natgillin/translations-raw huggingface dataset:
ςέκινθε ςιτ όπα ιατνοχέραπ υοπ νώισερηπυ νωτ ςυοτσόκ υοτ αρετίαιδι ςαίσακιδαιδ ςήκιρτνεκ ςητ
Benchmarking the quality management systems of the European competent authorities to assure the quality of the tasks of the competent authorities will result in the harmonisation of the best regulatory practices.
ςυοτσόκ υοτ ό σιροθακ νοτ οχότσ ε ησηγόλοτσοκ νητ ιεσίχενυσ αθ ησηκίοιδ η ότυα οισίαλπ οτΣ νώλετ α ητσύσ νούχσι οτ ε ησέχσ εσ ύο σιναγρΟ υοτ αίριεπ ε.
The report of the first Pan-European Regulatory Forum conference is now available. “ Pan-European Regulatory Forum Report” can be obtained from the PERF web site (http: / /perf. eudra. org), by e-mail (perf@emea. eudra. org) or by writing to the PERF Secretariat at the EMEA address.
ςεσσώλγ
EMEA Work Programme 2001-2002
.
9
ςησαβσόρπ ςητ ησωίτλεβ ητ οχότσ οιρύκ ε ιατεσσίλεξε αν ιεζίχενυσ αθ ΑΕΜΕ υοτ ησέθοτσι αέν Η ακα ράφ ατ ε ησέχσ εσ ησηρόφορηλπ. η ιατενάβ αλιρεπ ατα έθ ησατέξε όπυ ατΣ ςαίεγυ ςαισό ηδ ςητ ιατετπά υοπ α έθ ανέ ονε ίεκιτνα.
The Agency’ s participation in the EU team in the International Conferences on Harmonisation for medicines for human and veterinary use (ICH and VICH) will continue in 2001-2002.
ε ησαίρδενυσ αισήτε αι νοέλπ ιενάβ αλιρεπ αθ ιακ εκητσίροιδσορπαναπε
ICH activities will in particular focus on maintenance, new therapies, pharmacovigilance and implementation of the electronic Common Technical Document (eCTD).
ςαίσαγρε α αργόρΠ 2001- 2002
1.9 Financial control EMEA Financial controller, a. i.
ΥΟΠ ΑΕΜΕ νωεσήτια ςησυενχίνα ςοτα ήτσυσ ύονιοκ υοτ
Claus CHRISTIANSEN In line with other European Union institutions, the EMEA will
2001
The EMEA will continue to cooperate with the World Health Organisation, in particular towards the completion in 2001 of the joint EMEA-WHO application tracking system – SIAMED.
νητ οχότσ ε ςωίρυκ ςαίεγΥ ησωνάγρΟ αι σόκγαΠ νητ ε ιατεζάγρενυσ αν ιεσίχενυσ αθ
Once the system has been fully tested it is intended to make the upgraded product available to partner authorities within the
υολέκαφ ύοκινχετ ύονιοκ (eCTD). ύοκινορτκελη υοτ ησηίοπολυ ςωίδι νύοθωρτνεκιπε αθ ςωχίοτσιτνα) ιακ
replace the function of financial control with an internal audit function.
νητσ ιακ ησηνπύργαπεοκα ραφ ητσ ςείεπαρεθ ςεέν εσ ησηρήταιδ ητσ ςητ ςετητόιρητσαρδ ιΟ ICH οδοίρεπ νητ άτακ ιακ ίετσιχενυσ 2001- 2002.
This process is expected to take 2-3 years due to the need to consult and coordinate with the European Commission and other EU bodies on the recasting of the financial regulation.
ησήρχ ήκιρταινητκ ιακ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ νωτ (ICH
European Economic Area, central and eastern European countries and other European countries.
ησινό ρανε νητ αιγ ςιεψέκσαιδ ςίενθειδ ςιτ άτακ ΕΕ ςητ αδά ο νητσ ύο σιναγρΟ υοτ ήχοτε υσ Η ΑΕΜΕ υοτ ησνυθύειδ ήκι ορδυχατ νητσ ςήλοτσιπε ςήκιτεχσ νιπότακ ή
This should facilitate harmonisation of regulatory authority tracking systems within Europe, with consequent benefits in terms of transparency and effectiveness of drug registration processes.
. υοίε ορδυχατ ύοκινορτκελη ωσέ
Whereas it is still difficult to outline the future set-up, the Agency’ s interim financial controller will continue to ensure the application of the financial regulation and prepare and commence the transition to a system of internal audit.
υοτ αίετα αργ ητσ
A priori control of budgetary transactions 2000-2002
(perf@ emea. eudra. org)
1.8 European Department for the Quality 12000 of Medicines
(http: // perf. eudra. org),
10000 Useful web sites:
υοτ ησέθοτσι νητσ ιατεθίταιδςησυελένυΣςήκιτσι θυρ ςήκϊαπωρυεναπ υοτώρπ υοτ ησεθκέ Η PERF
European Department for the Quality of Medicines/ European Pharmacopoeia http: / /www. pheur. org
(‘ acquis
8000 6000
:
50
υοτ ςοχότσ αίταρκο η∆ ήκιχεσΤ ιακ αίνεβολΣ αίκαβολΣ PERF II),
The EMEA will maintain its collaboration with the European Pharmacopoeia on matters relating to product quality by:
,,,,,,,,,
4000
νώρωχ ησωνΈ ήκϊαπωρυΕ νητ ε νωνέ εδεδνυσ νωτ νώχρα νωιδό ρα νώκινθε νωτ ήχοτε υσ ητ εΜ οτ αιγ
• participation in the work of the European Pharmacopoeia Commission as part of the European Commission delegation
2001.
2000
υοπίρεπ εσ άκιλονυσ ιεθλένα αθ υοπ όσοπ ανέ ε
• by inviting representatives of the European Pharmacopoeia
ςοτα άργορπ
Secretariat to attend meetings of the Joint CPMP/ CVMP
PHARE
2000
2001.
2001
ςαίσαγρε α αργόρΠ 2001- 2002
2002
όκιλεΤ EMEA/ MB/ 003/ 01- EL - ΣΕΖΕ ΧΟΕ νώταρκ νωτ
Quality Working Party and the ad hoc Good Manufacturing Practice Inspectors’ meetings
αθ ατνόϊορπ αΤ
Other financial transactions Personnel related Payment orders
υοτ αιεκράιδ ητσ ίετσιχενυσ αθ ςαίσακιδαιδ ςήκιρτνεκ ςητ 2001
The contractual agreement and collaboration between the Commitment proposals European Department for the Quality of Medicines and the EMEA for the sampling and testing of centrally authorised products will continue in 2001 and 2002.
οισίαλπ οτσ νωνέ ιρκεκγε νωτνόϊορπ οχγελέ νοτ ιακ αίψηλοτα γιεδ ητ αιγ ΑΕΜΕ υοτ ιακ νωκά ραΦ νωτ ατητόιοΠ νητ αιγ ςαίσερηπΥ ςήκϊαπωρυΕ ςητ ύξατε αίσαγρενυσ η ιακ ησαβ ύσ ασίεθφανυσ Η ςήυεκσαραπ νώκιτκαρπ νώθρο νώτηρωεθιπε νώκιδιε νωτ ςιεσάιρδενυσ.
Products will be Additional activities will include the delivery of opinions on included in each of these annual programmes when they reach financial systems and procedures and, in cooperation with the the third anniversary of receiving the Community marketing IT sector, the development of a specific tool for financial control authorisation or where there is a specific need as agreed by that links in with the EMEA accounting system, SI2. the EMEA scientific committees.
ςαίσαγρε ςαδά ο ςήνιοκ ςητ ςιεσάιρδενυσ ςιτσ
Testing will be carried out on a work sharing basis by the Official Medicines Testing Laboratories of the European Union and EEA-EFTA Member States.
EMEA
10 EMEA Work Programme 2001-2002
http: // www. pheur. org
Chapter 2 Medicines for human use Overview
αίιοποκα ραΦ ήκϊαπωρυΕ
The Units for the evaluation of medicines for human use are responsible for:
/
•
νωκά ραΦ νωτ ατητόιοΠ νητ αιγ αίσερηπΥ ήκϊαπωρυΕ: ησνυθύειδ ήκινορτκελη η ισήρΧ
provision of support to scientific advice and protocol assistance to sponsors
ραΦ νω τ ατητό ιοΠ νητ αιγ αίσερηπΥ ή κϊαπωρυΕ
• management and follow-up of marketing authorisation applications under the centralised procedure
1. 8
•
ςαίσαγρε α αργόρΠ 2001- 2002
management of Community referrals and arbitrations arising from the mutual recognition procedure
υοτ α ητσύσ όκιτσιγολ οτ ε ησεδνύσ εσ υοχγέλε ύοκι ονοισο ηδ υοίελαγρε ύοκιδιε ςόνε ηξυτπάνα νητ νώιροφορηλπ νωτ ςαίγολονχετ ςητ αέ οτ νοτ ε αίσαγρενυσ εσ ιακ ςείσακιδαιδ ιακ ατα ήτσυσ
• post-authorisation maintenance and pharmacovigilance of centrally authorised medicinal products • management of and follow-up of designation for orphan medicinal products
ατ ίρεπ ιεσέκραιδ αθ ιτό ιατά ιτκε ήτυα ησαβάτε 2- 3
provision of support to European and international harmonisation activities of the CPMP and working parties and of the COMP in relation to orphan medicinal products.
Η υοχγέλε ύοκιρετωσε αίγρυοτιελ αι ε υοχγέλε ύοκι ονοισο ηδ υοτ αίγρυοτιελ ητ ιεσήτσατακιτνα. αν ιατιεκόρπ ΑΕΜΕ ο ςησωνΈ ςήκϊαπωρυΕ ςητ αναγρό άκι σεθ αλλά ατ ε ςονε όζινο ρανΕ,
Unit for the Pre-authorisation evaluation of medicines for human use Head of Unit Patrick LE COURTOIS Head of Sector, Scientific advice and orphan drugs Patrick LE COURTOIS (acting) Head of Sector, Quality of medicines John PURVES Head of Sector, Safety and efficacy of medicines Isabelle MOULON Deputy Head of Sector, Safety and efficacy of medicines Marisa PAPALUCA AMATI
Yann LE CAM Josep TORRENT i FARNELL
Committee for Proprietary Medicinal Products Chairman Daniel BRASSEUR Vice-Chairman Eric ABADIE Committee for Orphan Medicinal Products Chairman Josep TORRENT i FARNELL Vice-Chairman Yann LE CAM Working parties and ad hoc groups Biotechnology Working Party
ςορδεόρπιτνΑ ςορδεόρΠ
Unit for the Post-authorisation evaluation of medicines for human use
ακα ράφ άναφρο ατ αιγ ήπορτιπΕ
Jean-Hughes TROUVIN Efficacy Working Party
Eric ABADIE Daniel BRASSEUR
Head of Unit Noël WATHION
ςορδεόρπιτνΑ ςορδεόρΠ
Barbara VAN ZWEITEN-BOOT Pharmacovigilance Working Party
νωτά σαυεκσοιδΙ νώκιτυεκα ραΦ ήπορτιπΕ
Fernando GARCIA ALONSO Joint CPMP/CVMP Quality Working Party Jean-Louis ROBERT Safety Working Party Beatriz SILVA LIMA Scientific Advice Review Group Markku TOIVONEN
ςαίεδα ςησηγήροχ ςητ ιατεπέ υοπ νωτνόϊορπ νώκιτυεκα ραφ νωτ
ad hoc Working Group on Blood Products Manfred HAASE Herbal Medicinal Products Working Party Konstantin KELLER
νώκιτυεκα ραφ νωτ
EMEA Work Programme 2001-2002
ςαίεδα ςησηγήροχ ςητ ιατεπέ υοπ νωτνόϊορπ ατητόκιτα σελετοπα ιακ αιελάφσα νητ ιακ
11
ησηνπύργαπεοκα ραφ νητ αιγ αέ οτ ςονε άτσϊορΠ
Re-organisation of the Unit for the Evaluation of Medicinal Products for Human Use
νωεσέθοπυ νώκιτσι θυρ αέ οτ ςονε άτσϊορΠ
In addition, there will be a better use of the professional qualifications and experience of staff members.
ςαδάνο ςονε άτσϊορΠ ςαιεδά
One of the primary goals for the new units and sec tors will be
ςησηγήροχ ςητ ιατεπέ υοπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ ησηγόλοιξα νητ αιγ αδάνοΜ
The Unit for the Evaluation of Medicinal Products for Human Use was re-organised at the beginning of 2001 as a result of changes in the profile and volume of work of the Unit.
νωκά ραφ νωτ ατητόκιτα σελετοπα νητ
Two new units have been created, dealing with pre- and with post-authorisation activities.
ιακ αιελάφσα νητ αιγ αέ οτ ςονε άτσϊορπ ςήτωρηλπανΑ
to implement the changes in operational activities that result from the restructuring of the Unit for the Evaluation of Medicinal Products for Human Use.
νωκά ραφ νωτ ατητόκιτα σελετοπα
The implementation will be helped by the quality management system that has already been put in place within the Agency
νητ ιακ αιελάφσα νητ αιγ αέ οτ ςονε άτσϊορΠ
These changes are intended to facilitate the efficient handling of tasks, while maintaining support to the Committee for Proprietary Medicinal Products (CPMP), its working parties and to the Committee for Orphan Medicinal Products (COMP).
νωκά ραφ νωτ ατητόιοπ νητ αιγ αέ οτ ςονε άτσϊορΠ
The new structures will also improve the consistency in the operation of the centralised procedure (both from a procedural and a scientific point of view).
)
and in particular the use of standard operating procedures to assist the consistent handling of the various activities associated with the centralised procedure.
ακα ράφ άναφρο ατ ιακ νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ αιγ αέ οτ ςονε άτσϊορΠ
Further developments and implementation of the quality management system will be pursued to increase the robustness of the centralised procedure in relation to the review process.
Patrick LE COURTOIS
Priorities for medicines for human use in 2001-2002:
ςαδάνο ςονε άτσϊορΠ ςαιεδά ςησηγήροχ
In the post-authorisation field:
ςητ ιατίεγηορπ υοπ ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ ησηγόλοιξα νητ αιγ αδάνοΜ
To implement a procedure for the annual follow-up of designated products and to identify experts on rare diseases for the benefit of the Agency processes from designation to
ατνόϊορπ άκιτυεκα ραφ άναφρο ε ησέχσ εσ
To improve the management of a significant increase in maintenance activities as a consequence of the growing
(COMP) ακα ράφ άναφρο ατ αιγ ςήπορτιπε ςητ ιακ ςήτυα
marketing authorisation.
ςαίσαγρε νωδά ο νωτ ιακ
number of centrally authorised products.
ςητ ςησινό ρανε νωτήτοιρητσαρδ νώνθειδ ιακ νώκϊαπωρυε ηξιρήτσ ητ
To measure performance through a survey of post-authorisation activities, especially in relation to variation and line extension applications.
CPMP ςησιρώνγανα ςαίαβιο α αίσακιδαιδ ητ όπα νυοτπύκορπ υοπ νώισητιαιδ ιακ νώισακιδαιδ νώκιτπ επαραπ νώκιτονιοκ νωτ ησιρίεχαιδ ητ ςανυερέ ςητ ςετόδοτα ηρχ ςυοτσ υολλόκοτωρπ ησιτράτακ νητ αιγ ςή ορδνυσ ήχοραπ νητ ιακ νώλυοβ υσ νώκινο ητσιπε ήχοραπ νητ ε ηξιρήτσοπυ νητ, νωτνόϊορπ νώκιτυεκα ραφ νώναφρο ύο σιρητκαραχ υοτ ησηθύολοκαραπ ιακ ησιρίεχαιδ ητ ςαίσακιδαιδ ςήκιρτνεκ ςητ ιεσάβ νωτνόϊορπ νώκιτυεκα ραφ νωνέ ιρκεκγε ςαίροφολκυκ ςαιεδά ςησοδκέ ςητ ιατεπέ υοπ ησηνπύργαπεοκα ραφ ητ ιακ ςαίροφολκυκ νώιεδα ησηρήταιδ ητ ςαίσακιδαιδ ςήκιρτνεκ ςητ ιεσάβ ςαίροφολκυκ νώιεδα ςησηγήροχ νωεσήτια νωτ ησηθύολοκαραπ νητ ιακ ησιρίεχαιδ ητ αιγ ςενυθύεπυ ιανίε ησήρχ ηνιπώρθνα αιγ νωτνόϊορπ νώκιτυεκα ραφ ςησηγόλοιξα ςεδάνο ιΟ: ησηπόκσιπε ήκινεΓ ησήρχ ηνιπώρθνα αιγ ατνόϊορπ άκιτυεκα ραΦ
To implement the protocol assistance policy for orphan medicinal products for scientific and regulatory aspects in a framework allowing the interaction and communication expected by sponsors.
οιαλ άφεΚ
To develop a follow-up of the protocol
ςαίσαγρε α αργόρΠ 2001- 2002
To implement the electronic transmission and management of individual case safety reports in 2002 through the EudraVigilance project that allows for the establishment of a pharmacovigilance database and the use of a data-processing network.
EMEA/ MB/ 003/ 01- EL -
assistance procedure up to the marketing authorisation phase and to monitor the impact of the protocol assistance on such marketing authorisation procedure for medicinal products using the central route.
Konstantin KELLER Manfred HAASE Markku TOIVONEN Beatriz SILVA LIMA Jean- Louis ROBERT Fernando Garcia Alonso Barbara VAN ZWEITEN- BOOT Jean- Hughes TROUVIN
To increase the quality of the provision of scientific advice through strengthened interactions with companies and involvement of complimentary expertise.
ατνόϊορπ άκιτυεκα ραφ άκιτυφ ατ αιγ ςαίσαγρε αδά Ο ςοτα ία ατνόϊορπ ατ αιγ ςαίσαγρε αδά ο ήκιδιΕ νώλυοβ υσ νώκινο ητσιπε νωτ ςησηπόκσανα αδά Ο αιελάφσα νητ αιγ ςαίσαγρε αδά Ο ατητόιοπ νητ αιγCPMP/ CVMP ςαίσαγρε αδά ο ήνιοΚ ησηνπύργαπεοκα ραφ ητ αιγ ςαίσαγρε αδά Ο ατητόκιτα σελετοπα νητ αιγ ςαίσαγρε αδά Ο αίγολονχετοιβ ητ αιγ ςαίσαγρε αδά Ο ςεδά ο (ad hoc) ςέκιδιε ιακ ςαίσαγρε ςεδά Ο
To foresee in an adequate follow-up through continuous dialogue with the companies allowing to further improve the monitoring of the impact of the provision of scientific advice on the marketing authorisation procedure for medicinal products using the central route.
ςαίσαγρε α αργόρΠ 2001- 2002
In the pre-authorisation field:
όπα οσότ ςαίσακιδαιδ ςήκιρτνεκ ςητ ςαίγρυοτιελ ατητόκιτκενυσ ητ ςησίπε νυοσώιτλεβ αθ ςέ οδ ςεέν (
To continue the quality assurance exercise through continuous monitoring of the centralised marketing authorisation procedure by means of the EMEA-European Federation of Pharmaceutical Industries and Associations (EFPIA) survey.
ακα ράφ άναφρο ατ αιγ ήπορτιπΕ νητ ςορπ ιακ ςητ ςαίσαγρε ςεδά ο ςιτ ιακ
To increase the EMEA contribution in such quality improvement through a strengthened involvement of the EMEA scientific expertise through its specialised groups.
νωτά
In the orphan drugs field:
(COMP). σαυεκσοιδΙ νώκιτυεκα ραΦ ήπορτιπΕ νητ ςορπ ηξιρήτσοπυ νητ αληλλάραπ ςατνώρηταιδ
To further strengthen the provision of advice given to sponsors applying for orphan drugs designation in order to improve the quality of the applications and to reduce the time for validation.
(CPMP),
12 EMEA Work Programme 2001-2002
ςαίσαγρε ςητ ό σιριεχ όκιτα σελετοπα νοτ νυονύλοκυειδ αν νυοχέ όποκσ ςέτυα ςέγαλλα ιΟ, αχιοτσίτνα ςαίροφολκυκ ςαιεδά. ησηγήροχ ητ άτε ιακ νιρπ ςετητόιρητσαρδ ςιτ ε ςενέ σιτροφιπε ςεδάνο ςεέν ούδ νακηθήγρυοι η∆, ςητ ςαίσαγρε ςητ οκγό νοτσ ιακ αρήτκαραχ οτσ νώγαλλα νωτ α σελέτοπα ςω
To identify the areas for improvement in the functioning of the Committee, with a view of developing an action plan in order to allow the CPMP to cope with its increasing workload and to
υοτ ςέχρα ςιτσ 2001
prepare for future challenges (such as gene therapy, cell therapy and medicinal products derived from transgenic animals and transgenic plants) as a result of the EU 2001 review of the marketing authorisation procedures.
όκιλεΤ
In the field of transparency:
ςαίσαγρε α αργόρΠ 2001- 2002
In the field of harmonisation:
EMEA/ MB/ 003/ 01- EL - υοτ ΕΕ ςητ ςαίροφολκυκ νώιεδα ςησηγήροχ νώισακιδαιδ 2001. νωτ ςησατέξεναπε ςητ α σελέτοπα ςω άτυφ άκαιδινογαιδ ιακ αώζ άκαιδινογαιδ όπα ιατνοχρέορπ) υοπ ατνόϊορπ άκιτυεκα ραφ ατ ιακ αίεπαρεθοραττυκ η αίεπαρεθ ήκαιδινογ η ςωπό ςοτνολλέ
To further promote the implementation of a single EU market for medicinal products via harmonisation activities with focus on the product information for nationally authorised products and on the technical requirements in the field of quality, safety and efficacy through the development and updating of CPMP
υοτ ςιεσήλκορπ ςιτ αιγ ίετσα ιοτεορπ αν ιακ ςητ ςαίσαγρε οτρόφ ονε όναξυα νοτ ςώχυτιπε
To further improve the transparency of the Agency’s activities, with special emphasis on the operation of the centralised procedure.
υοτ νωδάνο νωνέ υεκιδιεξε νωτ ωσέ ΑΕΜΕ υοτ.
To increase the interaction and discussions with all stakeholders in order to implement changes in the Agency’s
νωνέ οδεδ
guidance documents.
ςαίσαγρεξεπε υούτκιδ ςησήρχ ιακ ςησηνπύργαπεοκα ραφ νωνέ οδεδ ςησάβ ςαίγρυοι ηδ
The extent of such harmonisation activities will have to be adjusted according to the funding made available by the EU.
υοίδεχσ υοτ ωσέ
transparency policy, especially in the post-authorisation field.
οτ ςιεσώτπιρεπ
In the field of international collaboration:
ςαίσαγρε α αργόρΠ
To further strengthen the collaboration with the national
2001
The workload arising from these priorities can be seen in the increase in meeting days forecast for 2001 and 2002.
2000
200 192 183
44
150 149 100
42
50
36
70
70
36
192
42
183
44
2002.
2000
οτ αιγ ίεθφελβορπ νυοχέ υοπ ςησαίρδενυσ νώρε η 2001
2001
οτ
CPMP meetings Working party meetings Other meetings
ςητ ςιεσάιρδενυΣ
EMEA Work Programme 2001-2002
οτ
13
CPMP ςητ ςιεσάιρδενυΣ 2001 οτ CPMP
2.1 Initial evaluation
ςητ ςιεσάιρδενυΣ
The Committee for Proprietary Medicinal Products began a new three-year mandate in January 2001.
οτ ιακ
Discussions on the future
2001
The number of applications for initial evaluation is expected to increase in 2001 and 2002.
οτ ησάβ αίαινη εσ ιεζάιρδενυσ αν ιεσίχενυσ αθ
A large number of these applications will be for authorisation of
νολλέ οτσ ιεσίπωτε ιτνα αν ίεθηλκ αθ υοπ. ςιεσήλκορπ ςιτ αιγ ιακ ςητ ςαίσαγρε υοτρόφ υοτ ησηξύα ητωίε ησοιξα ηνε όνε ανα νητ αιγ ήπορτιπε
organisation of CPMP meetings will be initiated in 2001 in order to allow the elaboration of proposals with a view of preparing the Committee for the expected significant increase in workload as well as the future challenges it will face.
ςητ νωεσάιρδενυσ
medicines designated under new orphan drug legislation in 2000 and 2001.
νωτ ησωνάγρο ήκιτνολλε η ιατίετηζυσ αν ιεσίχρα αθ υοτ ςότνΕ
Fee reductions for this are granted from a special contribution to the EMEA budget from the EU general budget. • Increase in initial evaluation work of 40% in 2001 and 42% in 2002
2001
The CPMP will continue to meet in 2001 and 2002 on a monthly basis.
2001
CPMP meetings in 2001 CPMP meetings in 2002 (to be confirmed) 3-25 January1 15-17 January1
ςίενεθσα εσ ιακ ςαίεγυ ςητ αέ οτ υοτ ςείτα λεγγαπε εσ ιατνεθίταιδ
• Improve quality and consistency of CPMP assessment reports and EPARs • Improve quality, consistency and readability of information
υοπ νώιροφορηλπ νωτ
29-31 May1 28-30 May1 26-28 June 25-27 June
ςησωνγάνα ςαιερέχυε ιακ ςατητόκιτκενυσ ςατητόιοπ ςητ ησωίτλεΒ ςείσυο ςέκιτσαρδ ςιτ ησάβ ε ςιεσήτια ςεέΝ) () ατνόϊορπ άκιτυεκα ραφ ατ ησάβ ε ςιεσήτια ςεέΝ (
23-25 July1
,
80
EPARs
21-23 August2
2002 2001
20-22 August2
2000
74
0 10 20
60
60 59 74 73 2000- 2002 ςησηγόλοιξα ςήκιχρα ςιεσήτιΑ
15-17 October
30 40 50 60 70 80
30
ςήκιχρα νώισαγρε νωτ ησηξύΑ 40% ΑΕΜΕ
40
2. 1
1 1-13 December
αδίλεΣ
17-19 December
όκιλεΤ
20 10 0
ίετσαιερχ νοσόφε νονόΜ υοίρβ εκε∆ 17- 19 1
1 Rapporteurs to be appointed
2
2 Only if required
ADR
2001
2001
As this process nears completion it is expected that the number of type II variations in 2001 will drop by comparison.
200 300
This expected decrease also
14000
This includes follow-up measures, specific obligations, annual reassessments, renewals of marketing authorisations, pharmacovigilance (expedited reporting of adverse drug reports (ADRs) and management of periodic safety update reports (PSURs). • Increase in applications for renewal of marketing authorisations to 24 in 2001 and 22 in 2002
11285
reflects a relatively high number of class-related labelling changes submitted in 2000.
5000 10000
• Increase in EU and non-EU ADRs and PSURs as the stock of centrally authorised products on the market increases
480
• An overall increase in the level of activities related to post-
458
authorisation applications is expected
400
Eu and non-Eu adverse drug reports 2000-2002
17000
• Develop and implement performance indicators in 2001-2002
14372
25000
560
Post-authorisation applications 2000-2002
500 600
20000
22000
22000
18000
18000
(ADR)
17000
II I
400
346
346
2001
250
2000
292
0 50
200 150
90
232
82
150
80
160
100
100 50
νώλυοβ υσ νωτ νωνέ οναβ αλιρεπ υσ νώλυοβ υσ νώκινο ητσιπε ήχοραπ αιγ νωεσήτια ςέλοβοπΥ
Periodic safety reports, follow-up measures and specific obligations 2000-2002
12, 5
2000
οτ
28
2. 4
26
2001- 2002
2002
οτ αιγ ςησηρήταιδ ςετητόιρητσαρδ ςιτΣ όκιλεΤ
32
2002
600 560
2001 320
Type I variations
2000 189
Type II variations
0 100 200
Extensions
350
500
300 400
400
ςή
458
οτ
480
εσ ιακ
300 294
2002.
200 100
350
206
320
252
2000 οτ
2000
οτ
2001
2002.
2002
2001
PSURs
οτ όπα υοίλυοβ υΣ υοτ
FUM - SO EMEA Work Programme 2001-2002
12
• Increase in the number of Community referrals (Articles 7(5), 12 and 15 of Council Directive 75/319/EEC) from 4 in 2000 to 7 in 2001 and 8 in 2002
ςοφαργάραπ ορθρά νώισακιδαιδ νώκιτπ επαραπ νώκιτονιοκ νωτ ύο θιρα υοτ ησηξύΑ
The Group is supported by the Sector for scientific advice and orphan drugs.
5,
Arbitration and Community referrals 2000-2002
7
30 • Increase in the number of initial and follow-up scientific 8 advice procedures of 2.5% in 2001 and 12.5% in 2002 7
(
Scientific advice submissions
οτ
20
εσ ιακ
22
οτ όπα υοίλυοβ υΣ
(including follow-up advice) 2000-2002
11
100
ςέ αργ
80 90 80 8 2
58
4
6
2000
60 80
2001
CPMP 2000 -
2000
οτ ιακ
2001
2001
Scientific advice procedures will be streamlined in 2001 for greater efficiency, including the operation of the Scientific Advice Review Group.
οτ εσ 6
2.6 Special services
οτ όπα
2.8 Orphan medicinal products
2000
The EMEA role in orphan medicinal products began in 2000 and the Committee for Orphan Medicinal Products (COMP) was established in April 2000.
2Ι ησινό
400 300
ρανε (CH)
320
νητ αιγ ηψεκσάιδ ήνθειδ ητ ε ησέχσ εσ
350
CPMP ςητ νώ αργ νωιρήτνυθυετακ νωτ ησηξύΑ
The Committee for Orphan Medicinal Products will meet in 2001 and 2002 on a monthly basis.
2002
200
οτ
100
58
189
εσ ιακ
COMP meetings in 2001 COMP meetings in 2002 (to be confirmed)
2001 οτ 62 εσ 2000 οτ 26 όπα CPMP ςητ νώ αργ νωιρήτ
2000
οτ 58 εσ ιακ 2001 οτ
2001
62 εσ 2000 οτ 26 όπα CPMP ςητ νώ αργ νωιρ
2002
εσ ιακ 2001 οτ 62 εσ
15-16 January 8-9 February
2000 οτ 26 όπα CPMP
22-23 January 26-27 February
οτ 58 εσ ιακ 2001 οτ 62 εσ 2000 οτ
20-21 March
26
25-26 March
όπα
2.7 Guideline development
CPMP
9-10 April
ςητ νώ
29-30 April
αργ νωιρήτνυθυετακ νωτ ησηξύΑ
The development and continuous revision of CPMP guidelines is an important contribution to ensuring harmonisation of
ησωνΈ ήκϊαπωρυΕ νητ όπα νωρόπ νώκιτοδοτα ηρχ.
22-23 May
ςαιεκράπε ςητ ησεθόπϋορπ νητ όπυ
22-23 May
ςαίσαγρε νωδά ο νωτ
The Units will continue to support the
ογρέ οτ νυοζίρητσοπυ CPMP,
11-12 June
αν νυοσίχενυσ αθ ςεδάνο ιΟ ςαίροφολκυκ νώιεδα ςησηγήροχ ςοτα ήτσυσ ύοκϊαπωρυε υοτ. οισίαλπ οτσ ςησηγόλοιξα νωίρητιρκ νώκινο ητσιπε νωτ ςησινό ρανε ςητ ησιλάφσαιδ ητσ ήλοβ υσ ήκιτνα ησ ίελετοπα
19-20 June
ςητ νώ αργ νωιρήτνυθυετακ νωτ ησηρώεθανα ςήκραιδ ιακ ησιτράτακ Η CPMP
work of the CPMP working parties, subject to the availability of
νώ αργ νω ιρή τ νυθυετακ ησιτράταΚ
17-18 July
2. 7
17-18 July
25/ 65
funding from the European Union.
αδίλεΣ
6-7 September
όκιλεΤ
11-12 September
ςαίσαγρε α αργόρΠ 2001- 2002
Increase in CPMP guidelines from 26 in 2000 to 62 in 2001 and 58 in 2002
EMEA/ MB/ 003/ 01- EL -
25-26 October
οτ ιακ
8-9 October
οτ ςερέ η
Increase in ICH-derived CPMP guidelines from 2 in 2000 to
2002
20-21 November
εσ
14-15 November
2001
6 in 2001 and 2002
οτ ςερέ η
17-18 December
όπα ακα
12-13 December