qanastek/EMEA-V3 huggingface dataset:
EMEA/ CPMP/ BWP/3207/00
EMEA/CPMP/BWP/3207/00
Note for Guidance on Comparability of medicinal products containing biotechnology-derived proteins as active substances Released for consultation May 2000
Note for Guidance on comparability of medicinal products containing biotechnology-derived proteins as active substances Publicada para consulta en mayo de 2000
EMEA/CPMP/BWP/1143/00
EMEA/CPMP/BWP/1143/00
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Released for consultation July 2000
Position statement on the Use of tumorigenic cells of human origin for the production of biological and biotechnological medicinal products Publicada para consulta en julio de 2000
EMEA/CPMP/BWP/269/95rev.
EMEA/CPMP/BWP/269/95 rev.
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Released for consultation July 2000
Revision of section 3.2.5 of CPMP Note for guidance on Plasma-derived medicinal products Publicada para consulta en julio de 2000
EMEA/CPMP/BWP/2571/00
EMEA/CPMP/BWP/2571/00
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Released for consultation November 2000
Points to consider on the Reduction, elimination or substitution of thiomersal in vaccines Publicada para consulta en noviembre de 2000
CPMP Blood and Plasma Working Group
Grupo de trabajo del CPMP «Sangre y plasma»
EMEA/CPMP/BPWG/575/99
EMEA/CPMP/BPWG/575/99
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Note for guidance on the Clinical investigation of human anti-D immunoglobulin for intravenous and/or intramuscular use Adoptada en junio de 2000
EMEA/CPMP/BPWG/388/95 rev.
EMEA/CPMP/BPWG/388/95 rev.
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Note for guidance on the Clinical investigation of human normal immunoglobulin for intravenous administration (IVIg) Adoptada en junio de 2000
EMEA/CPMP/BPWG/574/99
EMEA/CPMP/BPWG/574/99
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adopted June 2000
Core SPC for Human and anti-D immunoglobulin for intravenous and/or intramuscular use Adoptada en junio de 2000
EMEA/CPMP/BPWG/859/95 rev.
EMEA/CPMP/BPWG/859/95 rev.
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adopted June 2000
Core SPC for Human normal immunoglobulin for intravenous administration (IVIg) Adoptada en junio de 2000
EMEA/ CPMP/ BPWG/1619/99
EMEA/ CPMP/ BPWG/1619/99
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adopted June 2000
Core SPC for Human plasma derived and recombinant coagulation factor VIII products Adoptada en junio de 2000
EMEA/ CPMP/ BPWG/1625/99
EMEA/CPMP/BPWG/ 198/95 rev.1
Core SPC for Human plasma derived and recombinant coagulation factor IX products Adopted June 2000
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adoptada en octubre de 2000
EMEA/CPMP/BPWG/198/95 rev.1
EMEA/ CPMP/ BPWG/ 1561/ 99
Note for Guidance on the Clinical investigation of human plasma derived factor VIII and IX products Adopted October 2000
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adoptada en octubre de 2000
EMEA/CPMP/BPWG/ 1561/99
1
Note for Guidance on the Clinical investigation of recombinant factor VIII and IX products Adopted October 2000
Core SPC for Human albumin Adoptada en octubre de 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Publicada para consulta en junio de 2000
84 EMEA General Report 2000
EMEA/CPMP/BPWG/1561/99
1
EMEA/CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Core SPC for Human albumin Adopted October 2000 Note for guidance on the Clinical investigation of human plasma derived factor VIII and IX products Released for consultation June 2000
Core SPC for Human albumin Publicada para consulta en junio de 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Publicada para consulta en diciembre de 2000
EMEA/ CPMP/ BPWG/1561/99
EMEA/CPMP/BPWG/3226/99
Note for guidance on the Clinical investigation of recombinant factor VIII and IX products Released for consultation June 2000
Core SPC for Human plasma derived antithrombin Publicada para consulta en diciembre de 2000
EMEA/ CPMP/PhvWP/BPWG/ 2231/99 EMEA/CPMP/BPWG/2220/99
Grupo de trabajo del CPMP «Eficacia»
Core SPC for Human albumin Released for consultation June 2000 Note for Guidance on the Clinical investigation of plasma derived antithrombin products Released for consultation December 2000
Note for Guidance on clinical investigation of steroid contraceptives in woman Adoptada en febrero de 2000
EMEA/ CPMP/BPWG/3226/99
EMEA/ CPMP/ EWP/197/99
Core SPC for Human plasma derived antithrombin Released for consultation December 2000
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adoptada en febrero de 2000
CPMP Efficacy Working Party Reference number
EMEA/ CPMP/ EWP/570/98
Guidelines/Status
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST- segment elevation Adoptada en febrero de 2000
EMEA/ CPMP/ EWP/519/98
EMEA/ CPMP/ EWP/2922/99
Note for Guidance on clinical investigation of steroid contraceptives in woman Adopted February 2000
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adoptada en febrero de 2000
EMEA/ CPMP/ EWP/197/99
EMEA/ CPMP/ EWP/2863/99
Points to consider concerning Endpoints in clinical studies with haematopoietic growth factors for mobilisation of autologous stem cells Adopted February 2000
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adoptada en febrero de 2000
EMEA/ CPMP/ EWP/570/98
EMEA/ CPMP/ EWP/707/98
Points to consider on the clinical investigation of new medicinal products for treatment of acute coronary syndrome (ACS) without persistent ST-segment elevation Adopted February 2000
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adoptada en junio de 2000
EMEA/ CPMP/ EWP/2922/99
EMEA/ CPMP/ EWP/612/00
Concept paper on the development of a CPMP Note for Guidance on the clinical investigation of medicinal products in the treatment of asthma Adopted February 2000
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adoptada en junio de 2000
EMEA/ CPMP/ EWP/2863/99
EMEA/ CPMP/ EWP/2655/99
Concept paper on the development of a CPMP Points to Consider on biostatistical/methodological issues arising from CPMP discussions on licensing applications: adjustment for baseline covariates Adopted February 2000
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adoptada en julio de 2000
EMEA/ CPMP/ EWP/707/98
EMEA/ CPMP/ EWP/482/99
Points to consider on Clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk Adopted June 2000
Points to consider on switching between superiority and non-inferiority Adoptada en julio de 2000
EMEA/ CPMP/ EWP/612/00
EMEA/ CPMP/ EWP/1080/00
Concept paper on the Development of a CPMP Note for Guidance on the Clinical investigation of medicinal products in pain management Adopted June 2000
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adoptada en octubre de 2000
EMEA/ CPMP/ EWP/2655/99
EMEA/ CPMP/ EWP/785/97
Points to consider on pharmaco-kinetics and pharmacodynamics in the development of anti-bacterial medicinal products Adopted July 2000
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adoptada en noviembre de 2000
EMEA/ CPMP/ EWP/482/99
EMEA/ CPMP/ EWP/2284/99
Points to consider on switching between superiority and non-inferiority Adopted July 2000
Points to consider on Clinical investigation of medicinal products for the management of Crohn’s disease Publicada para consulta en julio de 2000
EMEA/ CPMP/ EWP/1080/00
EMEA/ CPMP/ EWP/560/98
Concept paper on the Development of a CPMP Note for Guidance on Clinical investigation of medicinal products in the treatment of diabetes mellitus Adopted July 2000
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Publicada para consulta en octubre de 2000
EMEA/ CPMP/ EWP/565/98
EMEA/ CPMP/ EWP/2330/99
Points to consider on Clinical investigation of medicinal products for treatment of Amyotrophic Lateral Sclerosis (ALS) Adopted October 2000
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Publicada para consulta en octubre de 2000
EMEA/CPMP/EWP/785/97
EMEA/CPMP/EWP/1119/98
Concept paper on the Evaluation of drugs for the treatment of the irritable bowel syndrome Adopted November 2000
Points to consider on the Evaluation of diagnostic agents Publicada para consulta en noviembre de 2000
1
EMEA/CPMP/EWP/714/98
Note for Guidance on Clinical investigation of medicinal products in the treatment of epileptic disorders Adopted in November 2000
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Publicada para consulta en noviembre de 2000
EMEA/CPMP/EWP/2284/99
EMEA/CPMP/EWP/QWP/ 1401/98 EMEA/CPMP/EWP/2747/00
Points to consider on Clinical investigation of medicinal products for the management of Crohn's disease Released for consultation July 2000
Note for Guidance on the investigation of bioavailability and bioequivalence Publicada para consulta en diciembre de 2000 Note for Guidance on co-ordinating investigator signature of clinical study reports Publicada para consulta en diciembre de 2000
85 EMEA General Report 2000
Grupo de trabajo del CPMP «Farmacovigilancia»
1
Número de referencia
Note for Guidance on Evaluation of anticancer medicinal products in man Released for consultation July 2000 and extended in September 2000 for a further 2 months
Directrices/Situación
EMEA/ CPMP/ EWP/560/98
EMEA/ CPMP/PhVWP/2058/99
Points to consider on Clinical investigation of medicinal products in the treatment of acute stroke Released for consultation October 2000
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent aut- horities, and the Pharmaceutical Industry Publicado para consulta en mayo de 2000
EMEA/ CPMP/ EWP/2330/99
EMEA/ CPMP/ SWP/2775/99
Points to consider on Validity and interpretation of meta-analyses, and one pivotal study Released for consultation October 2000
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adoptada en abril de 2000
EMEA/ CPMP/ EWP/1119/98
EMEA/ CPMP/ SWP/1042/99
Points to consider on the Evaluation of diagnostic agents Released for consultation November 2000
Note for Guidance on Repeated dose toxicity Adoptada en julio de 2000
EMEA/ CPMP/ EWP/714/98
EMEA/CPMP/SWP/2278/00
Note for Guidance on Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease Released for consultation November 2000
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adoptada en diciembre de 2000
EMEA/ CPMP/EWP/QWP/ 1401/98
EMEA/CPMP/SWP/4163/00
Note for Guidance on the investigation of bioavailability and bioequivalence Released for consultation December 2000
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adoptada en diciembre de 2000
EMEA/CPMP/EWP/2747/00
EMEA/CPMP/SWP/2145/00 Draft 4
Note for Guidance on co-ordinating investigator signature of clinical study reports Released for consultation December 2000
Note for Guidance on Non-clinical local tolerance testing of medicinal products Publicada para consulta en septiembre de 2000
CPMP Pharmacovigilance Working Party
Grupo de trabajo de la EMEA sobre medicamentos de origen vegetal
Guidelines/Status
EMEA/HMPWP/23/00
EMEA/CPMP/PhVWP/2058/99
CPMP/QWP/2819/00
Joint Pilot Plan for the implementation of the electronic transmission of individual case safety reports between the EMEA, national competent authorities, and the Pharmaceutical Industry Released for consultation May 2000
Note for guidance on quality of herbal medicinal products Publicada para consulta en noviembre de 2000
CPMP Safety Working Party
86 Informe General EMEA 2000
EMEA/ CPMP/ SWP/2775/99
EMEA/ CVMP/133/99
CPMP Position paper on Selective Serotonin Uptake Inhibitors (SSRIs) and dependency/withdrawal reactions Adopted April 2000
Conduct of pharmacokinetic studies in animals Adoptada en marzo de 2000
EMEA/ CPMP/ SWP/1042/99
EMEA/ CVMP/344/99
Note for Guidance on Repeated dose toxicity Adopted July 2000
Conduct of efficacy studies for intramammary products for use in cattle Adoptada en marzo de 2000
EMEA/ CPMP/ SWP/2278/00
EMEA/CVMP/005/00
Discussion paper on Possible pre-clinical studies to investigate addiction and dependence/withdrawal related to use of SSRIs Adopted December 2000
Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in cats and dogs Adoptada en noviembre de 2000
EMEA /CPMP/SWP/4163/00
EMEA/CVMP/016/00
Concept paper on the Development of a CPMP Points to consider on the need for reproduction toxicity studies in the development of human insulin analogues Adopted December 2000
The conduct of bioequivalence studies for veterinary medicinal products Publicada para consulta en enero de 2000
EMEA/CPMP/SWP/2145/00 Draft 4
CVMP/VICH/546/00
Note for Guidance on Non-clinical local tolerance testing of medicinal products Released for consultation September 2000
Specific recommendations for poultry Publicada para consulta en julio de 2000
EMEA Herbal Medicinal Products Working Party
CVMP/VICH/545/00
Reference number
Efficacy of anthelmintics:
EMEA/HMPWP/23/00
CVMP/IWP/52/97
Position paper on the Risks associated with the use of Herbal Products containing Aristolochia Species Adopted by the Working Party in October 2000
Requirements for combined veterinary vaccines Adoptada en marzo de 2000
CPMP/QWP/2819/00
CVMP/IWP/07/98
Note for guidance on quality of herbal medicinal products Released for consultation November 2000
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adoptada en marzo de 2000
CPMP/QWP/2820/00
EMEA/CVMP/682/99
Note for guidance on specifications: test procedures and acceptance criteria for herbal drugs, herbal drug preparations and herbal medicinal products Released for consultation November 2000
Duration of protection achieved by veterinary vaccines Adoptada en octubre de 2000
CVMP Efficacy Working Party Reference number EMEA/ CVMP/133/99
EMEA/ CVMP/852/99
Guidelines/Status Conduct of pharmacokinetic studies in animals Adopted March 2000
Field trials with veterinary vaccines Publicada para consulta en marzo de 2000
EMEA/ CVMP/344/99
EMEA/ CVMP/743/00
Conduct of efficacy studies for intramammary products for use in cattle Adopted March 2000
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Publicada para consulta en octubre de 2000
EMEA/ CVMP/005/00
EMEA/ CVMP/044/99
Testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in cats and dogs Adopted November 2000
Conduct of post-marketing surveillance studies of veterinary medicinal products Adoptada en abril de 2000
EMEA/CVMP/016/00
CVMP/VICH/547/00
The conduct of bioequivalence studies for veterinary medicinal products Released for consultation January 2000
Management of adverse event reports (AERs) Publicada para consulta en julio de 2000
CVMP/VICH/546/00
Directrices/Situación
Efficacy of anthelmintics:
EMEA/ CVMP/276/99
Specific recommendations for poultry Released for consultation July 2000
Assessment of the effect of antimicrobial substances on dairy starter cultures Adoptada en marzo de 2000
CVMP/VICH/545/00
EMEA/ CVMP/473/98
Specific recommendations for feline Released for consultation July 2000
Determination of withdrawal periods for milk Adoptada en marzo de 2000
CVMP Immunologicals Working Party Reference number CVMP/IWP/52/97
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adoptada en julio de 2000
Guidelines/Status Requirements for combined veterinary vaccines Adopted March 2000
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Publicada para consulta en mayo de 2000
CVMP/IWP/07/98
CVMP/VICH/526/00
DNA vaccines non-amplifiable in eukaryotic cells for veterinary use Adopted March 2000
Genotoxicity studies Publicada para consulta en julio de 2000
EMEA/ CVMP/682/99
CVMP/VICH/525/00
Duration of protection achieved by veterinary vaccines Adopted October 2000
Reproduction studies Publicada para consulta en julio de 2000
EMEA/ CVMP/852/99
CPMP/ QWP/1676/00
Field trials with veterinary vaccines Released for consultation March 2000
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adoptada en julio de 2000
EMEA/CVMP/743/00
CPMP/ QWP/3015/99
Requirements and controls applied to bovine serum (foetal or calf) used in the protection of immunological veterinary medicinal products Released for consultation October 2000
Note for Guidance on Parametric Release Publicada para consulta en marzo de 2000
CVMP Pharmacovigilance Working Party
CPMP/QWP/1719/00
Reference number EMEA/ CVMP/044/99
CPMP/QWP/2845/00
Guidelines/Status Conduct of post-marketing surveillance studies of veterinary medicinal products Adopted April 2000
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Publicada para consulta en noviembre de 2000
CVMP/VICH/547/00
CPMP/QWP/2820/00 (CVMP/815/00)
Management of adverse event reports (AERs) Released for consultation July 2000
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Publicada para consulta en noviembre de 2000
CVMP Safety Working Party
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/CVMP/065/99
linesStatus number
Development pharmaceutics for veterinary medicinal products:
Reference
EMEA/ CVMP/422/99
Guidelines/Status
Declaration of storage conditions for veterinary medicinal products in the product particulars Adoptada en febrero de 2000
EMEA/ CVMP/276/99
CVMP/ VICH/501/99
Assessment of the effect of antimicrobial substances on dairy starter cultures Adopted March 2000
Stability testing of biotechnological/biological veterinary medicinal products Adoptada en junio de 2000
EMEA/ CVMP/473/98
CVMP/VICH/502/99
Determination of withdrawal periods for milk Adopted March 2000
Impurities: residual solvents Adoptada en junio de 2000
CVMP/ VICH/592/98
EMEA/ CVMP/198/99
Environmental impact assessment (EIAS) for veterinary medicinal products - Phase 1 Adopted July 2000
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adoptada en julio de 2000
EMEA/CVMP/187/00
CVMP/VICH/595/98
Risk analysis approach for residues of veterinary medicinal products in food of animal origin Released for consultation May 2000
Good clinical practices Adoptada en julio de 2000
CVMP/VICH/526/00
EMEA/CVMP/846/99
Genotoxicity studies Released for consultation July 2000
Stability testing of existing active substances and related finished products Adoptada en noviembre de 2000
CVMP/VICH/525/00
EMEA/CVMP/816/00
Reproduction studies Released for consultation July 2000
Statistical principles for veterinary clinical trials Publicada para consulta en noviembre de 2000
87 EMEA General Report 2000
Grupo de trabajo ad hoc de inspectores de BPL
Joint CPMP/CVMP Quality Working Party
Número de referencia
Reference number
Directrices/Situación
Guidelines/Status
ENTR/III/5717/99
CPMP/ QWP/1676/00
ENTR/6266/00
Concept Paper on the Development of a CPMP/CVMP Note for Guidance on Quality of Water for Pharmaceutical Use Adopted July 2000
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalizada en abril de 2000
CPMP/ QWP/3015/99
ENTR/6270/00
Note for Guidance on Parametric Release Released for consultation March 2000
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Publicada para consulta en abril de 2000
CPMP/ QWP/1719/00
88 Agencia Europea para la Evaluación de Medicamentos
Note for Guidance on Medicinal Gases – Pharmaceutical Information Released for consultation July 2000
Sexto Informe General sobre las Actividades de la Agencia Europea para la Evaluación de Medicamentos — 2000
CPMP/QWP/2845/00
Luxemburgo:
Note for Guidance on Requirements for Pharmaceutical Documentation for Pressurised Metered Dose Inhalation Products Released for consultation November 2000
ISBN 92-9155-032-9 Venta • Salg • Verkauf • Pvlèseiw • Sales • Vente • Vendita • Verkoop • Venda • Myynti • Försäljning http://eur-op.eu.int/general/en/s-ad.htm BELGIQUE/BELGIË
CPMP/QWP/2820/00 (CVMP/815/00)
Ltd 5369 Chemin Canotek Road, Unit 1
Note for Guidance on Specifications:
(43-1) 53 16 11 00 Fax (43-1) 53 16 11 67
Test Procedures and Acceptance Criteria for Herbal Drugs, Herbal Drug Preparations and Herbal Medicinal Products Released for consultation November 2000
(372) 646 02 44 Fax (372) 646 02 45
CPMP/QWP/2819/00 (CVMP/814/00) EMEA/ CVMP/065/99
Ottawa, Ontario K1J 9J3 Tel.
Note for Guidance on Quality of Herbal Medicinal Products Released for consultation November 2000 Annex to Guideline:
URL: http://www.jean-de-lannoy.be La librairie européenne/ De Europese Boekhandel Rue de la Loi 244/Wetstraat 244
Development pharmaceutics for veterinary medicinal products:
E-Mail: manz@schwinge.at URL: http://www.manz.at PORTUGAL
Decision trees for the selection of sterilisation methods Adopted February 2000
(351) 214 95 87 87
EMEA/ CVMP/422/99
HR-10000 Zagreb Tel.
Declaration of storage conditions for veterinary medicinal products in the product particulars Adopted February 2000
(32-2) 552 22 11
CVMP/VICH/501/99
Fax (32-2) 511 01 84
Stability testing of biotechnological/biological veterinary medicinal products Adopted June 2000
(49-221) 97 66 80 Fax (49-221) 97 66 82 78 E-Mail: vertrieb@bundesanzeiger.de
CVMP/ VICH/502/99
POLSKA Ars Polona
Impurities: residual solvents Adopted June 2000
Krakowskie Przedmiescie 7 Skr. pocztowa 1001
EMEA/ CVMP/198/99
(48-22) 826 12 01
Maximum shelf-life for sterile medicinal products after first opening or following reconstitution Adopted July 2000
(30-1) 331 41 80/1/2/3/4/5
CVMP/VICH/595/98
S-221 82 Lund Tlf.
Good clinical practices Adopted July 2000
UNITED KINGDOM The Stationery Office Ltd
EMEA/CVMP/846/99
Centrum VTI SR Nám.
Stability testing of existing active substances and related finished products Adopted November 2000
Fax (421-7) 54 41 83 64 E-mail: europ@tbb1.sltk.stuba.sk URL: http://www.sltk.stuba.sk SLOVENIJA
EMEA/CVMP/816/00
Fax (354) 552 55 60
Statistical principles for veterinary clinical trials Released for consultation November 2000
Fax (34) 915 75 39 98 E-mail: libreria@mundiprensa.es URL: http://www.mundiprensa.com
Ad hoc GMP Inspectors Working Group
(386) 613 09 16 40 Fax (386) 613 09 16 45
Reference number
2146 Sandton Tel.
Guidelines/Status
Boks 6512 Etterstad
ENTR/ III/5717/99
N-0606 Oslo Tel.
Revised Version of Annex 14 - Manufacture of medicinal products derived from human blood or plasma to the EU Guide to Good Manufacturing Practice Finalised in February 2000
(82-2) 22 53-5631/4
ENTR/6266/00
EBIC Sri Lanka
Procedure for Handling Rapid Alerts and Recalls Arising from Quality Defects Finalised in April 2000
Fax (54-11) 48 15 81 56 E-mail: wpbooks@infovia.com.ar URL: http://www.wpbooks.com.ar
ENTR/6109/00
(359-2) 980 37 66
Draft Annex 6 to EU Guide to Good Manufacturing Practice on Medicinal Gases Released for consultation March 2000
(1-800) 274 44 47 (toll free telephone)
ENTR/6270/00
Publikaci
Draft Annex 17 to EU Guide to Good Manufacturing Practice on Parametric Release Released for consultation April 2000
Fax (1-800) 865 34 50 (toll free fax) E-mail: query@bernan.com URL: http://www.bernan.com
88
Tél.
The European Agency for the Evaluation of Medicinal Products
De La Agencia Europea para la Evaluación de Medicamentos
Seventh Annual Report 2001
Séptimo informe general 2001
Adopted by the Management Board on 18 December 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Adoptado por el Consejo de Administración el 18 de diciembre de 2001 The annual report for 2001 is presented to the Management Board by the Executive Director in accordance with Article 55(3) of Council Regulation (EEC) No 2309/ 93.
Previous annual reports and other reference documents are available from the EMEA web site at http: / /www. emea. eu. int
Previous annual reports and other reference documents are available from the EMEA web site at http: / /www. emea. eu. int
The Report, in accordance with Article 15c(1) of Council Directive 75/ 319/ EEC and Article 23c(1) of Council Directive 81/ 851/ EEC, also summarises the operation of the decentralised (mutual recognition) procedure during 2001.
The Report, in accordance with Article 15c(1) of Council Directive 75/ 319/ EEC and Article 23c(1) of Council Directive 81/ 851/ EEC, also summarises the operation of the decentralised (mutual recognition) procedure during 2001.
New e-mail addresses for the EMEA staff members were introduced with effect from 1 November 2001 with the introduction of the ‘ emea. eu. int ’ domain for e- mail:
New e-mail addresses for the EMEA staff members were introduced with effect from 1 November 2001 with the introduction of the ‘ emea. eu. int’ domain for e- mail:
firstname. familyname@emea. eudra. org becomes: firstname. familyname@emea. eu. int
firstname. familyname@emea. eudra. org becomes: firstname. familyname@emea. eu. int
The general e-mail address for the EMEA becomes mail@emea. eu. int and other functional e-mail addresses will change in the same way, e. g. certificate@emea. eu. int
The general e-mail address for the EMEA becomes mail@emea. eu. int and other functional e-mail addresses will change in the same way, e. g. certificate@emea. eu. int
The ‘ emea. eudra. org’ e-mail address format will continue to be recognised until 1 October 2002.
The ‘ emea. eudra. org’ e-mail address format will continue to be recognised until 1 October 2002.
(44-20) 74 18 84 16 E-mail: mail@emea. eu. int Internet: http: / /www. emea. eu. int
(44-20) 74 18 84 16 E-mail: mail@emea. eu. int Internet: http: / /www. emea. eu. int
It can be accessed through the Europa server (http: / /europa. eu. int)
It can be accessed through the Europa server (http: / /europa. eu. int)
Foreword by the Chairman of the Management Board
Adoptado por el Consejo de Administración el 18 de diciembre de 2001
Chapter 3 Veterinary Medicines 3.1 Initial evaluation
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
3.2 Establishment of maximum residue limits for old substances
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. eu. int http: / /www. emea. eu. int Índice PREÁMBULO DEL PRESIDENTE DEL CONSEJO DE ADMINISTRACIÓN INTRODUCCIÓN DEL DIRECTOR EJECUTIVO ESTRUCTURA DE LA EMEA
5
5 6 7
3.3 Post-authorisation activities 3.4 Pharmacovigilance and maintenance activities
CAPÍTULO 1 LA EMEA EN EL SISTEMA EUROPEO 1.1 Consejo de Administración 1.2 Autoridades nacionales competentes 1.3 Transparencia y diálogo regulador 1.4 Revisión de las tasas de la EMEA
26 26
8 8 9 9 9
Chapter 1 EMEA in the European System
1.5 Revisión del sistema europeo de autorizaciones de comercialización 1.6 Gestión de la calidad 1.7 Colaboradores internacionales 1.8 Departamento Europeo para la Calidad de los Medicamentos 1.9 Control financiero
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CAPÍTULO 2 MEDICAMENTOS DE USO HUMANO 2.1 Evaluación inicial 2.2 Actividades posteriores a la autorización 2.3 Actividades de farmacovigilancia y mantenimiento 2.4 Asesoramiento científico 2.5 Arbitrajes y remisiones comunitarias 2.6 Servicios especiales 2.7 Actividades internacionales 2.8 Medicamentos huérfanos 2.9 Grupos de trabajo y grupos ad hoc 2.10 Grupo de facilitación del reconocimiento mutuo
International activities
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CAPÍTULO 3 MEDICAMENTOS VETERINARIOS 3.1 Evaluación inicial 3.2 Establecimiento de límites máximos de residuos para sustancias antiguas 3.3 Actividades posteriores a la autorización 3.4 Actividades de farmacovigilancia y mantenimiento 3.5 Asesoramiento científico 3.6 Arbitrajes y remisiones comunitarias 3.7 Partes interesadas 3.8 Actividades internacionales 3.9 Grupos de trabajo y grupos ad hoc 3.10 Grupo de facilitación del reconocimiento mutuo veterinario
Revision of EMEA fees
33 35 37 37 38 38 38 40 40 41 43
Chapter 4 Inspections
CAPÍTULO 4 INSPECCIONES
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Chapter 5 Administration and Support Activities 5.1 Administration 5.2 Document management and publishing
CAPÍTULO 5 ADMINISTRACIÓN Y SERVICIOS DE APOYO 5.1 Administración 5.2 Gestión y publicación de documentos 5.3 Organización de reuniones y servicios de conferencias 5.4 Tecnología de la información
32 32 33
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Chapter 2 Medicines for Human Use 2.1 Initial evaluation 2.2 Post-authorisation activities
ANEXOS Anexo 1 Miembros del Consejo de Administración Anexo 2 Miembros del Comité de Especialidades Farmacéuticas Anexo 3 Miembros del Comité de Medicamentos Veterinarios Anexo 4 Miembros del Comité de Medicamentos Huérfanos Anexo 5 Autoridades nacionales competentes que colaboran con la EMEA Anexo 6 Resumen de los presupuestos de la EMEA para el período 2000 – 2002 Anexo 7 Dictámenes del CPMP en 2001 para medicamentos de uso humano Anexo 8 Dictámenes del CVMP en 2001 para medicamentos de uso veterinario Anexo 9 Dictámenes del COMP en 2001 para la designación de medicamentos huérfanos Anexo 10 Directrices y documentos de trabajo en 2001 Anexo 11 Puntos de contacto de la EMEA
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54 55 56 57 58 59 63 64 68 71 78 83
5.3 5.4
Es remitido también al Parlamento Europeo, al Consejo, a la Comisión y a los Estados miembros.
Meeting management and conferences Information technology
Está disponible previa petición en todas las lenguas oficiales de la UE.
Pharmacovigilance and maintenance activities Scientific advice Arbitration and Community referrals
Los informes anuales correspondientes a años anteriores y otros documentos de referencia están disponibles en el sitio web de la EMEA en http: / /www. emea. eu. int
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En el capítulo 1 se describen las actividades del Consejo de Administración, las relaciones de la Agencia con las autoridades nacionales competentes y las instituciones europeas, y otras actividades generales de la EMEA, entre ellas las referentes a transparencia y relaciones internacionales.
Annexes 1 Members of the Management Board 2 Members of the Committee for Proprietary
Los aspectos operativos y técnicos del trabajo de la EMEA en 2001 se exponen en el capítulo 2 sobre medicamentos de uso humano, en el capítulo 3 sobre medicamentos de uso veterinario, y en el capítulo 4 sobre actividades de inspección.
International activities
Por último, el capítulo 5 trata de los asuntos relacionados con la administración y otras actividades de apoyo.
3 Members of the Committee for Veterinary Medicinal Products
De conformidad con el apartado 1 del artículo 15c de la Directiva 75/ 319/ CEE del Consejo y el apartado 1 del artículo 23c de la Directiva 81/ 851/ CEE del Consejo, el informe expone asimismo, de forma resumida, el funcionamiento del procedimiento descentralizado (reconocimiento mutuo) en 2001.
4 Members of the Committee for Orphan
El 1 de diciembre de 2001 se introdujeron nuevas direcciones de correo electrónico para el personal de la EMEA, al implantarse el dominio ‘ emea. eu. int’ para el correo electrónico
Working parties and ad hoc groups
nombre. apellido@emea. eudra. org
2.10 Mutual recognition facilitation group
nombre. apellido@emea. eu. int
National competent authority partners EMEA budget summaries 2000-2002 CPMP opinions in 2001 on medicinal products for human use CVMP opinions in 2001 on medicinal products for veterinary use COMP opinions in 2001 on designation of orphan medicinal products
La dirección general de correo electrónico para la EMEA pasa a ser mail@emea. eu. int y otras direcciones funcionales cambiarán del mismo modo, por ejemplo certificate@emea. eu. int
43 47 48 51 53
El formato de dirección ‘ emea. eudra. org’ seguirá siendo reconocido hasta el 1 de octubre de 2002.
Guidelines and working documents in 2001 EMEA contact points
Este cambio de dominio es la consecuencia lógica del cambio delsitio web de la Agencia a www. emea. eu. int a principios de 2001 y forma parte de la adaptación de la EMEA al uso de otras instituciones y órganos de la Unión Europea.
EMEA mission statement
Declaración de misión de la EMEA
The EMEA plays a role in both procedures:
Contribuir a la protección y promoción de la salud humana y animal mediante:
To contribute to the protection and promotion of public and animal health by: • Mobilising scientific resources from throughout the European Union to provide high quality evaluation of medicinal products, to advise on research and development programmes and to provide useful and clear information to users and health professionals
La movilización de recursos científicos en toda la Unión Europea para realizar una evaluación de alta calidad de los nuevos medicamentos, ofrecer asesoramiento sobre los programas de investigación y desarrollo, y proporcionar información útil a los usuarios y profesionales de los servicios sanitarios.
Applications are submitted directly to the EMEA.
El desarrollo de procedimientos eficaces y transparentes que permitan el acceso puntual de los usuarios a los nuevos medicamentos mediante una única autorización europea de comercialización.
At the conclusion of the scientific evaluation undertaken in 210 days within the Agency, the opinion of the scientific committee is transmitted to the European Commission to be transformed into a single market authorisation applying to the whole European Union.
El aumento de la seguridad de los medicamentos de uso humano y veterinario, en particular a través de una red de farmacovigilancia, y el establecimiento de límites de seguridad de los residuos en animales destinados a la alimentación.
• Developing efficient and transparent procedures to allow timely access by users to innovative medicines through a single European marketing authorisation
La EMEA interviene en ambos procedimientos:
The decentralised procedure (or mutual recognition procedure) applies to the majority of conventional medicinal products and is based upon the principle of mutual recognition of national authorisations.
Las solicitudes se remiten directamente a la EMEA.
It provides for the extension of marketing authorisations granted by one
Al concluir la evaluación científica realizada en un plazo de 210 días por la Agencia, el dictamen del comité científico es transmitido a la Comisión Europea para que lo transforme en una autorización de comercialización única aplicable en toda la Unión Europea.
• Controlling the safety of medicines for humans and animals, in particular through a pharmacovigilance network and the establishment of safe limits for residues in food-producing animals
El procedimiento descentralizado (o procedimiento de reconocimiento mutuo) es aplicable a la mayoría de los medicamentos convencionales y se basa en el principio del reconocimiento mutuo de las autorizaciones nacionales.
Member State to one or more other Member States identified by the applicant.
Permite la extensión de las autorizaciones de comercialización concedidas por un Estado miembro a uno o más Estados miembros identificados por el solicitante.
Where the original national authorisation cannot be recognised, the points in dispute are submitted to the EMEA for arbitration.
En el caso de que una autorización nacional original no pueda reconocerse, los puntos que susciten controversia se remitirán a la EMEA para arbitraje.
The opinion of the scientific committee is transmitted to the European Commission.
El dictamen del comité científico se transmite a la Comisión Europea.
The European Commission adopts its decision with the assistance of a standing committee composed of representatives of the Member States.
La Comisión Europea adopta su decisión con la ayuda de una comisión permanente compuesta por representantes de los Estados miembros.
EMEA Annual Report 2001
2001 fue un año de continuos éxitos para la EMEA, conseguidos pese a los numerosos cambios que tuvieron lugar.
We welcomed Thomas Lönngren at the start of the year as the new Executive Director.
Acogimos a Thomas Lönngren a principios de año como nuevo Director Ejecutivo.
The Management Board elected a new chairman and several organisational changes were adopted within the Agency with a view to improving both efficiency and effectiveness.
El Consejo de Administración eligió a un nuevo presidente y se aprobaron una serie de cambios en la organización de la Agencia, con vistas a mejorar su eficiencia y eficacia.
The environment within which the EMEA operated also saw significant change, the nature and extent of which is likely to increase even further in the future.
El entorno en el que opera la EMEA fue también testigo de cambios importantes, cuya naturaleza y extensión probablemente sigan aumentando en el futuro.
The Agency, its management, its staff and its advisors, took all of these changes in their stride, and achieved all that was expected of them, as is described in this report.
La Agencia, sus directivos, sus empleados y sus asesores, estuvieron a la altura de todos estos cambios y lograron todo lo que se esperaba de ellos, como queda reflejado en el presente informe.
None of this will be achieved in isolation and the Agency will work hard to harness the good will, experience, knowledge and expertise of all existing regulators in this venture.
La Agencia desempeña ya una función operativa única en la aplicación de la política comunitaria para alcanzar altos niveles de salud pública y culminar la creación de un mercado único farmacéutico, sin perjuicio del desarrollo de una industria competitiva importante en la esfera internacional.
A closer association of heads of the national authorities to the Agency’s resource planning will be important in achieving better joint management of the resources available across the entire Community.
Ahora tiene que mirar hacia delante y prepararse para un futuro interesante, emocionante y ambicioso con la perspectiva de un aumento de la demanda en nuevos ámbitos de la terapéutica y la normativa.
The Management
Los numerosos colaboradores de la Agencia, entre ellos las instituciones europeas, las autoridades competentes de los Estados miembros, los ciudadanos de la Comunidad Europea, los pacientes, los representantes de los pacientes y la industria farmacéutica, seguirán depositando grandes esperanzas en esta Agencia y, en mi opinión, la Agencia está en condiciones de colmar esas esperanzas.
The Agency already has a unique operational role in implementing the Community policy for high standards of public health and completion of the single market in pharmaceuticals, without prejudicing the development of an important internationally competitive industry.
Los importantes retos del futuro que la EMEA está dispuesta a afrontar son la ampliación de la Comunidad, la implantación de la Revisión 2001, el aumento de los ensayos clínicos, las funciones de farmacovigilancia e inspección, la responsabilidad de los sistemas de gestión de la información farmacéutica de la Comunidad, la ampliación del proceso de transparencia a todos los aspectos de su función, la mejora de su capacidad de aplicar la legislación y cumplimiento de su labor internacional.
It must now look forward and prepare for an interesting, exciting and challenging future with the prospect of increasing demands in new areas of therapeutics and regulation.
Para lograr todo ello, tendrá que asegurarse una base sólida y estable de gobernanza corporativa y mantener los niveles más altos de prácticas administrativas, incluida la gestión del rendimiento.
The Agency’s many stakeholders, including the European institutions, the competent authorities of Member States, citizens of the European Community, patients, patient representatives and the pharmaceutical industry, will continue to have high expectations of this Agency, and the Agency is in my opinion, in a position to deliver against those expectations.
El Consejo de Administración tendrá la importante función de asegurar que los directivos de la Agencia estén debidamente preparados y cuenten con el apoyo necesario para hacer frente a todos esos retos.
Board also wishes to thank all of the members of the Agency’s expert committees and the 3 000 independent European experts for their important contribution to these accomplishments.
Será importante estrechar la colaboración con los responsables de las autoridades nacionales para la planificación de los recursos de la Agencia, si se quiere lograr una mejor gestión conjunta de los recursos disponibles en toda la Comunidad.
The important challenges of the future, against which the EMEA is determined to deliver, include enlargement of the Community, implementation of the 2001 Review, increasing clinical trials, pharmacovigilance and inspection functions, responsibility for Community pharmaceutical information management systems, extending the process of transparency to every aspect of its function, improving its ability to enforce regulation, and fulfilling its international role.
Mis compañeros y yo en el Consejo de Administración quisiéramos expresar nuestro agradecimiento a todos los que han contribuido al éxito de la EMEA, especialmente a los empleados por su buen trabajo y su dedicación durante todo el año.
To achieve all of this it will need to ensure a sound and stable basis of good corporate governance, and maintain the highest standards of management practice, including performance management.
Sin esa dedicación no hubiera sido posible conseguir tantos logros como los que se describen en el presente informe.
4 EMEA Annual Report 2001
El Consejo de Administración quiere expresar asimismo su agradecimiento a todos los miembros de los comités de expertos de la Agencia y a los 3.000 expertos europeos independientes por su importante contribución a dichos logros.
Introduction by the Executive Director Thomas Lönngren
Introducción del Director Ejecutivo Thomas Lönngren
This is my first annual report as Executive Director of the European Agency for the Evaluation of Medicinal Products.
Este es mi primer informe anual como Director Ejecutivo de la Agencia Europea para la Evaluación de Medicamentos.
As you will see from reading the report, it has been an exciting and challenging year for the Agency.
Como se desprende del informe, ha sido un año muy interesante y lleno de desafíos para la Agencia.
Important progress has also been made in the field of antimicrobial resistance, particularly in the field of veterinary medicines.
Una de mis primeras tareas fue elaborar un programa de trabajo y estoy satisfecho de ver que casi todas las prioridades y los objetivos que nos fijamos se han alcanzado.
Overall we have been able to handle incoming applications within the required timelines, despite an increase in the level of overall activities.
En conjunto, hemos sido capaces de tramitar las solicitudes recibidas dentro de los plazos establecidos, pese al aumento del nivel de actividades generales.
Significant resource has been directed to implementation of a new computerised system to improve the way the safety of medicines is monitored in the European Community.
Se han dedicado recursos importantes a la instalación de un nuevo sistema informático que mejorará la vigilancia de la seguridad de los medicamentos en la Comunidad Europea.
Similarly the EMEA has had to deal with a number of referrals made to it concerning medicines authorised through national procedures.
Igualmente, la EMEA ha tenido que tramitar una serie de expedientes relativos a medicamentos autorizados por medio de procedimientos nacionales.
The number of applications for designation of orphan medicines also exceeded original forecasts.
El número de solicitudes para la designación de medicamentos huérfanos también superó las previsiones iniciales.
An event that will have an important effect on the EMEA was the announcement by the European Commission of its proposals to reform the European system for the authorisation and supervision of medicines.
La prestación de asesoramiento científico a las empresas en la fase de investigación y desarrollo de nuevos medicamentos se ha convertido en una de las prioridades de la Agencia.
The proposals contain a number of new responsibilities for the Agency and an analysis of the resource and organisational consequences is already underway.
Una encuesta a empresas que han utilizado el procedimiento indica que hemos mejorado el servicio y yo espero que sigamos progresando en este terreno.
The EMEA became involved in a number of new activities during the year that had not been foreseen in the work programme.
Se ha hecho también un progreso importante en el campo de la resistencia a los antibióticos, especialmente en el campo de los medicamentos veterinarios.
A survey of companies who have used the
Un acontecimiento que tendrá una importante repercusión para la EMEA fue el anuncio por la Comisión Europea de sus propuestas para reformar el sistema europeo para la autorización y supervisión de medicamentos.
became actively involved together with the European Commission in preparing the Community response to the threats of bio-terrorism.
Las propuestas contemplan una serie de nuevas responsabilidades para la Agencia y ya se está realizando un análisis de sus consecuencias en términos de recursos y organización.
We have also worked closely with partners elsewhere in the world, both through the ICH and VICH initiatives and bilaterally.
La EMEA ha llevado a cabo algunas actividades nuevas durante el año que no se habían previsto en el programa de trabajo.
With the launch of a new web site at the beginning of 2001, we have begun also to look at ways of providing more information to people outside of the regulatory and pharmaceutical industry circles.
La Comisión Europea y los Estados miembros instaron a la EMEA a asumir la responsabilidad sobre la red de tecnología de la información (TI) para la regulación de productos farmacéuticos en 2003 y nosotros comenzamos los preparativos oportunos.
One important step forward that has been especially welcomed is the publication of summaries of opinions at the time they are adopted by our scientific committees.
Hacia finales de año colaboramos activamente con la Comisión Europea en la preparación de la respuesta de la Comunidad a las amenazas del bioterrorismo.
Amidst all this the Agency’s staff has been involved in a process of internal reorganisation throughout the year, including the creation of two units dealing with medicines for human use and of a new unit responsible for communications and networking with the Agency’s external partners.
Entre las actividades orientadas al exterior de la Unión Europea, hemos continuado con nuestro programa de cooperación con nuestros homólogos de países candidatos a la adhesión a través del PERF y me complace poder afirmar que se han hecho grandes progresos durante el año.
I take this opportunity to thank them all for their hard work.
Hemos trabajado también estrechamente con colaboradores de otros países, tanto a través de las iniciativas ICH y VICH como a través de acuerdos bilaterales.
EMEA Annual Report 2001
Con el lanzamiento de un nuevo sitio web a principios de 2001, hemos empezado también a considerar formas de proporcionar más información a personas ajenas a los círculos de la industria farmacéutica y los organismos de control.
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Aprovecho esta oportunidad para agradecerles lo mucho que han trabajado.