natgillin/translations-raw huggingface dataset:
Hvad angår den del, der omhandler virkninger og klinisk sikkerhed, blev der på ICH- mødet i Tokyo i september 1998 opnået enighed om omfanget af harmoniseringen af indholdsfortegnelsen for undersøgelsesrapporter og systematisk registrering af undersøgelserne.
For the efficacy and clinical safety part, the scope of harmonisation for the table of contents for study reports and tabulated listing of studies was agreed during the ICH meeting in Tokyo, which was held in September 1998.
Formålet hermed var at forberede udarbejdelsen af EU- holdningen vedrørende den del, der vedrører virkninger og klinisk sikkerhed, til mødet i Tokyo i september 1998.
A workshop of clinical assessors from all CPMP delegations chaired by Dr Barbara van Zwieten-Boot was held in order to prepare the EU position on the efficacy and clinical safety part for the September 1998 Tokyo meeting.
De vigtigste dokumenter, der blev udarbejdet af de enkelte arbejdsgrupper i 1998, og dokumenternes status vises senere i dette kapitel.
Highlights from each working party and the status of documents prepared in 1998 are given below.
Guidelines for lægemiddelkvalitet findes i kapitel 4.
Guidelines relating to pharmaceutical quality are presented in Chapter 4.
Lægemiddelovervågningsaktiviteter og arbejdsgruppen vedrørende lægemiddelovervågning
Pharmacovigilance activities and the Pharmacovigilance Working Party
Susan Wood (†) som formand, holdt 7 møder i 1998.
The Pharmacovigilance Working Party (PhVWP) chaired by Dr Susan Wood (†) held seven meetings in 1998.
Arbejdsgruppen behandlede 19 sager på anmodning af CPMP og 39 spørgsmål på anmodning af medlemsstaterne.
The working group considered 19 issues at the request of the CPMP and 39 issues at the request of the Member States.
Arbejdsgruppen vedrørende lægemiddelovervågning fortsatte arbejdet med at undersøge og behandle kritiske spørgsmål, der giver anledning til bekymring for sikkerheden ved centralt og nationalt godkendte lægemidler.
The Pharmacovigilance Working Party continued to review safety concerns in relation to centrally and nationally authorised medicinal products.
Arbejdsgruppen udformede en europæisk advarsel mod at føre køretøjer og betjene farlige maskiner i forbindelse med brug af insulin, som efterfølgende blev godkendt af CPMP.
In this respect a core European warning concerning driving and operation of machinery when using insulin was agreed upon by the working party and endorsed by the CPMP.
Arbejdsgruppen udarbejdede et dokument vedrørende operationelle anliggender, der efterfølgende blev vedtaget af CPMP: “ Principles of providing the World Health Organisation with pharmacovigilance information ”, som blev vedtaget i januar 1998 (CPMP/ PhV/ 053/ 98).
One document dealing with operational matters was agreed and subsequently adopted by the CPMP. ‘ Principles of providing the World Health Organisation with pharmacovigilance information’ was adopted in January 1998 (CPMP/ PhV/ 053/ 98).
Dette dokument vil blive indføjet i bind IX af “ De gældende regler for lægemidler i Den Europæiske Union ” (se bilag 8 for yderligere publikationsreferencer).
It will be included in Volume IX of ‘ The rules governing medicinal products in the European Union’ (see Annex 8 for publication details).
I 1998 modtog EMEA et stigende antal indberetninger om tilfælde uden for EU af formodede alvorlige uventede bivirkninger ved centralt godkendte produkter.
In 1998 the EMEA was notified of an increasing number of reports of suspected serious unexpected adverse drug reactions occurring outside the EU for centrally authorised products.
I alt modtog man 4 417 indberetninger om sådanne bivirkninger og 4 516 indberetninger om alvorlige bivirkninger inden for EU.
A total of 4 516 reports of serious adverse drug reactions which occurred within the EU were received.
For at forebygge en eventuel udfældning af det aktive stof i Norvir henstillede arbejdsgruppen, at anbefalingerne vedrørende opbevaring og holdbarhed ændredes.
In order to prevent potential precipitation of the active substance in Norvir, changes to the storage recommendations and shelf-life were recommended.
Dette fulgtes op af en type II - ændringsprocedure.
This was followed up by a type II variation procedure.
EF- markedsføringstilladelsen vedrørende Tasmar (tolcapon), der oprindelig var tilladt til supplerende behandling af Parkinsons sygdom, blev suspenderet, fordi det var blevet klart, at fordelene ikke opvejede de risici, der var forbundet med brugen.
The Community marketing authorisation for Tasmar (tolcapone), originally authorised for adjunctive treatment of Parkinson’ s disease, was suspended because it became apparent that its benefits did not outweigh the risks of use.
Bekymringer vedrørende Comtess (entacapon), der virker på nogenlunde samme måde som tolcapon, førte ligeledes til udformning af forskellige former for advarsler.
Concerns over Comtess (entacapone), which has a similar mode of action to tolcapone, also led to introduction of different warnings.
For lægemidlet Mabthera (rituximab), der er tilladt til behandling af visse former for lymfom, blev der vedtaget yderligere begrænsninger vedrørende brugen.
Mabthera (rituximab), authorised for the treatment of certain forms of lymphoma, was also subject to increased restrictions on use.
I hvert enkelt tilfælde udformede EMEA en offentlig meddelelse, som blev lagt ind på agenturets website.
In each case, a public statement was issued by the EMEA and made available on the Agency’ s website.
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29
Arbejdsgruppen vedrørende bioteknologi
Biotechnology Working Party
Giuseppe Vicari som formand, mødtes 8 gange i 1998.
The Biotechnology Working Party (BWP), chaired by Professor Giuseppe Vicari, met on eight occasions in 1998.
I 1998 fortsatte BWP med at yde faglig ekspertbistand til CPMP vedrørende ansøgninger, der indgives til EMEA.
During this year, the BWP has continued to provide specialist technical assistance to the CPMP on applications submitted to the EMEA.
Arbejdsgruppen har også ydet rådgivning vedrørende fremstilling og kontrol af bioteknologiske og biologiske lægemidler, herunder produkter fremstillet på basis af blod og plasma samt immunologiske produkter.
General advice has also been given on the manufacture and control of biotechnological and biological medicinal products, including products derived from blood and plasma, and of immunological products.
Formålet var at drøfte de foreliggende informationer om nyvarianter af Creutzfeldt- Jakob- sygdommen (nv- CJD) og TSE.
In the light of the emerging information, a workshop of international experts on transmissible spongiform encephalopathies (TSEs), convened under the auspices of the CPMP, was held on 15 January 1998 to consider the available information on new variant Creutzfeldt-Jakob disease (nv-CJD) and relevant TSEs.
CPMP vedtog den 25. februar 1998 et holdningsdokument om nv- CJD og lægemidler fremstillet på basis af plasma 1998 (CPMP/ 201/ 98), som indeholdt henstillinger vedrørende foranstaltninger i tilfælde af, at et anvendt lægemiddel viste sig at være fremstillet på basis af blod fra patienter med nv- CJD.
The CPMP adopted a position statement on nv-CJD and plasma-derived medicinal products on 25 February 1998 (CPMP/ 201/ 98), which included recommendations on the action to be taken in relationship to medicinal products, if donations were subsequently found to be from patients with nv-CJD.
Desuden foreslog BWP en revision af CPMP´s vejledningsnotat vedrørende minimering af risikoen for overførsel af spongiform encephalopati gennem lægemidler, som blev sendt til høring.
In addition, the BWP proposed a revision of the CPMP note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products, which was released for consultation.
Henstillingerne vedrørende fremstilling af talgbaserede stoffer til brug i farmaceutiske præparater (CPMP/ BWP/ 1163/ 97 - vedtaget i december 1997), samt henstillingerne vedrørende anvendelse af gelatine i farmaceutiske præparater blev medtaget i den foreslåede revision af CPMP´s guideline vedrørende TSE.
The recommendations (adopted in December 1997) for the production of tallow derivatives for use in pharmaceuticals (CPMP/ BWP/ 1163/ 97), as well as the recommendations for gelatine use in pharmaceuticals, were incorporated into the proposed revision of the ‘ TSE guideline’.
CPMP gav i denne sammenhæng sin tilslutning til forslaget om at afholde en workshop med deltagelse af CPMP/ BWP og andre berørte parter med henblik på udveksling af informationer om fremskridtene med at finde frem til assays til lokalisering af TSE- markører med henblik på potentiel anvendelse på lægemidler.
In this area, the CPMP also endorsed the need to hold a workshop between CPMP/ BWP and other interested parties to share the available information on the progress on assays for markers of TSE in relation to their potential applications to medicinal products.
Den første EMEA- workshop om genterapi blev afholdt den 23. april 1998.
The first EMEA workshop on gene therapy was held on 23 April 1998.
Formålet var at identificere prioriterede arbejdsfelter, at fremme nye lovende terapeutiske strategier og revidere genterapi- guidelines.
The objective of this workshop was to identify priorities, to facilitate the progress of new and promising therapeutic strategies and revise gene therapy guidelines.
I workshoppen deltog repræsentanter for Europa- Parlamentet og Kommissionen, CPMP- medlemmer og - eksperter samt repræsentanter for industrien, forskningsinstitutter og patientforeninger.
Participants of the workshop included representatives of the European Parliament, European Commission and members and experts of the CPMP, as well as representatives from industry, academia and patient groups.
EMEA fungerede som forum for denne udveksling af videnskabelig information, og debatten dannede grundlag for den igangværende revision af genterapi- guidelines.
The EMEA provided a forum for the exchange of scientific information and the debate was the basis for the ongoing revision of gene therapy guidelines.
På anmodning af Gruppen for Fremme af Gensidig Anerkendelse har arbejdsgruppen vedrørende bioteknologi ydet videnskabelig rådgivning vedrørende udvælgelse af virusstammer til influenzavacciner.
At the request of the Mutual Recognition Facilitation Group, the Biotechnology Working Party has provided scientific advice relating to the selection of virus strains for incorporation into influenza vaccines.
Henstillingen vedrørende anvendelsen af virusstammer i fremstillingen af influenzavaccine i Europa blev vedtaget med enstemmighed af de eksperter, der deltog i ad hoc- arbejdsgruppen vedrørende influenzavacciner, og BWP.
The recommendation for 30 influenza strains, for use in influenza vaccine production in Europe, was reached by consensus of opinion of the experts attending the ad hoc Influenza Working Group in conjunction with the Biotechnology Working Party.
EMEA/ MB/ 040/ 98 EMEA ’ årsberetning for 1998
The following documents were adopted or released for consultation by the CPMP in 1998:
Side 29
Reference number CPMP/ BWP/ 201/ 98
s
Guidelines New variant CJD and plasma-derived medicinal products
Følgende dokumenter blev vedtaget eller sendt til høring af CPMP i 1998:
Status Adopted in February 1998
Referencenummer CPMP/ BWP/ 201/ 98
CPMP/ BWP/ 921/ 98
Holdningsdokumenter New variant CJD and plasma- derived medicinal products
Report on selection of influenza vaccines strains for 1998/ 99
Status Vedtaget i februar 1998
Adopted in May 1998
CPMP/ BWP/ 921/ 98
CPMP/ BWP/ 972/ 98
Report on selection of influenza vaccines strains for 1998/ 99
Viral safety of oral poliovirus vaccine
Vedtaget i maj 1998
Adopted in May 1998
CPMP/ BWP/ 972/ 98 CPMP/ BWP/ 1952/ 98
CPMP/ BWP/ 1952/ 98
Viral safety of oral poliovirus vaccine Position statement on Polysorbate 80
Position statement on Polysorbate 80
Vedtaget i maj 1998 Vedtaget i oktober 1998
Adopted in October 1998
Referencenumber CPMP/ BWP/ 1106/ 97 CPMP/ BWP/ 1113/ 98
Reference number CPMP/ BWP/ 1106/ 97 CPMP/ BWP/ 1113/ 98
Konceptdokumenter Concept paper om gene therapy Concept paper on the development of a CPMP guideline on comparability of biotechnology- derived products
Guidelines Concept paper on gene therapy Concept paper on the development of a CPMP guideline on comparability of biotechnology-derived products
Status Vedtaget i januar 1998 Vedtaget i juni 1998
Status Adopted in January 1998 Adopted in June 1998
Referencenumber CPMP/ BWP/ 390/ 97
Reference number CPMP/ BWP/ 390/ 97
Guidelines The introduction of nucleic acid amplification technology (NAT) for the detection of hepatitis C virus RNA in plasma pools (addendum to note for guidance on plasma- derived medicinal products)
Guidelines The introduction of nucleic acid amplif ication technology (NAT) for the
Status Vedtaget i marts 1998
Status Adopted in March 1998
CPMP/ BWP/ 477/ 97
CPMP/ BWP/ 477/ 97
Pharmaceutical and biological aspects of combined vaccines
Pharmaceutical and biological aspects of combined vaccines
Vedtaget i juli 1998
Adopted in July 1998
CPMP/ BWP/ 269/ 95 rev. 2
CPMP/ BWP/ 269/ 95 rev.2
Note for guidance on plasma- derived medicinal products
Note for guidance on plasma-derived medicinal products
CPMP/ BWP/ 1230/ 98
CPMP/ BWP/ 1230/ 98
Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products.
Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products.
Revision October 1998
Revision October 1998
Sendt til høring i oktober 1998
Released for consultation in October 1998
Arbejdsgruppen vedrørende virkninger
Efficacy working party
Barbara van Zwieten- Boot, og desuden var der en række udbryder - og ad hoc- møder.
The efficacy working party (EWP), chaired by Professor Alfred Hildebrandt and co-chaired by Dr Barbara van Zwieten-Boot met on five occasions in 1998 with a number of break-out and ad hoc meetings.
Samarbejdet med de andre arbejdsgrupper fortsatte, navnlig med den fælles CPMP/ CVMP- arbejdsgruppe vedrørende kvalitet om orale og parenterale administrationsformer med modificeret frigivelseshastighed, med den fælles gruppe vedrørende kinetik og med BWP om klinisk undersøgelse af nye vacciner og genterapi.
Cooperation with the other working parties continued, particularly with the Joint CPMP/ CVMP quality working party on modified release oral and transdermal dosage form, with the joint group on kinetics and with the BWP on clinical investigation of new vaccines and gene therapy.
José Guimarães Morais som formand, mødtes 6 gange og fortsatte arbejdet med at ajourføre det eksisterende vejledningsnotat om biotilgængelighed og bioækvivalens og om populations- farmakokinetik (CPMP/ EWP/ QWP/ 1401/ 98).
The EWP/ QWP joint group on pharmacokinetics, chaired by Professor José Guimarães Morais, met six times and continued its task on updating the existing note for guidance on bioavailability and bioequivalence, as well as on population pharmacokinetics (CPMP/ EWP/ QWP/ 1401/ 98).
Følgende dokumenter blev vedtaget eller sendt til høring af CPMP i 1998.
The following documents were adopted or released for consultation by the CPMP in 1998:
Dokumenter med punkter, som bør tages i betragtning
Points to consider
CPMP/ EWP/ 784/ 97
CPMP/ EWP/ 784/ 97
Clinical investigation of medicinal products used in the treatment of osteoarthritis
Clinical investigation of medicinal products used in the treatment of osteoarthritis
CPMP/ EWP/ 556/ 95
CPMP/ EWP/ 556/ 98
Clinical investigation of slow- acting anti- rheumatic medicinal products in rheumatoid arthritis
Clinical investigation of slow-acting anti-rheumatic medicinal products in rheumatoid arthritis
Vedtaget i december 1998
Adopted in December 1998
CPMP/ EWP/ 562/ 98
CPMP/ EWP/ 562/ 98
Clinical investigation of medicinal products in the treatment of patients with chronic obstructive pulmonary disease
Clinical investigation of medicinal products in the treatment of patients with chronic obstructive pulmonary disease
Referencenummer CPMP/ EWP/ 518/ 97
CPMP/ EWP/ 518/ 97
Konceptdokumenter Clinical investigation of antidepressant agents medicinal products (revision)
Clinical investigation of antidepressant agents medicinal products (revision)
Status Vedtaget i januar 1998
Adopted in January 1998
CPMP/ EWP/ 561/ 98
CPMP/ EWP/ 561/ 98
Clinical investigation of medicinal products for the treatment of multiple sclerosis
Clinical investigation of medicinal products for the treatment of multiple sclerosis
CPMP/ EWP/ 567/ 98
CPMP/ EWP/ 567/ 98
Clinical investigation of medicinal products for the treatment of bipolar disorders
Clinical investigation of medicinal products for the treatment of bipolar disorders
CPMP/ EWP/ 560/ 98
CPMP/ EWP/ 560/ 98
Clinical investigation of medicinal products for the treatment of acute ischemic stroke
Clinical investigation of medicinal products for the treatment of acute ischemic stroke
CPMP/ EWP/ 566/ 98
CPMP/ EWP/ 566/ 98
Clinical investigation of medicinal products for the treatment of epileptic disorders (revision)
Clinical investigation of medicinal products for the treatment of epileptic disorders (revision)
CPMP/ EWP/ 571/ 98
CPMP/ EWP/ 571/ 98
Clinical investigation of medicinal products for the treatment of cardiac failure (revision)
Clinical investigation of medicinal products for the treatment of cardiac failure (revision)
CPMP/ EWP/ 714/ 98
CPMP/ EWP/ 714/ 98
Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease (revision)
Clinical investigation of medicinal products for the treatment of peripheral arterial occlusive disease (revision)
CPMP/ EWP/ 570/ 98
CPMP/ EWP/ 570/ 98
Clinical investigation of medicinal products for the treatment of unstable coronary artery disease
Clinical investigation of medicinal products for the treatment of unstable coronary artery disease
CPMP/ EWP/ 707/ 98
CPMP/ EWP/ 707/ 98
Clinical investigation of medicinal products for prophylactic the treatment of peri - and post- operative venous thrombo- embolic risk
Clinical investigation of medicinal products for prophylactic treatment of peri- and post-operative venous thrombo- embolic risk
CPMP/ EWP/ 563/ 98
CPMP/ EWP/ 563/ 98
Clinical investigation of medicinal products for the treatment of venous thrombo- embolic disease
Clinical investigation of medicinal products for treatment of venous thrombo-embolic disease
CPMP/ EWP/ 559/ 98
CPMP/ EWP/ 559/ 98
Clinical investigation of medicinal products for prevention and the treatment of osteoporosis in men
Clinical investigation of medicinal products for prevention and treatment of osteoporosis in men
CPMP/ EWP/ 565/ 98
CPMP/ EWP/ 565/ 98
Clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis
Clinical investigation of medicinal products for treatment of amyotrophic lateral sclerosis
CPMP/ EWP/ 1119/ 98
CPMP/ EWP/ 1119/ 98
The evaluation of diagnostic agents
The evaluation of diagnostic agents
Referencenummer CPMP/ EWP/ 559/ 95
CPMP/ EWP/ 559/ 95
Guidelines Clinical investigation of medicinal products in the treatment of schizophrenia
Clinical investigation of medicinal products in the treatment of schizophrenia
Status Vedtaget i februar 1998
Adopted in February 1998
CPMP/ ICH/ 289/ 95 (E5)
CPMP/ ICH/ 289/ 95 (E5)
Ethnic factors in the acceptability of foreign clinical data
Ethnic factors in the acceptability of foreign clinical data
Vedtaget i marts 1998
Adopted in March 1998
CPMP/ ICH/ 363/ 96 (E9)
CPMP/ ICH/ 363/ 96 (E9)
Statistical principles for clinical trials
Statistical principles for clinical trials
CPMP/ EWP/ 563/ 95
CPMP/ EWP/ 563/ 95
Clinical investigation of medicinal products in the treatment of Parkinson ’ disease s
Clinical investigation of medicinal products in the treatment of Parkinson's disease
CPMP/ EWP/ 280/ 96
CPMP/ EWP/ 280/ 96
Modified release oral and transdermal dosage forms:
Modif ied release oral and transdermal dosage forms:
Section I (pharmacokinetic and clinical evaluation)
Section I (pharmacokinetic and clinical evaluation)
CPMP/ EWP/ 436/ 97
CPMP/ EWP/ 436/ 97
Clinical investigation of new vaccines
Clinical investigation of new vaccines
Sendt til høring i juli 1998.
Released for consultation in July 1998
CPMP/ EWP/ 1401/ 98 (in collaboration with QWP)
CPMP/ EWP/ 1401/ 98 (in collaboration with QWP)
Investigation of bioavailability and bioequivalence
Investigation of bioavailability and bioequivalence
Sendt til høring i december 1998
Released for consultation in December 1998
© EMEA 1999
Safety Working Party
Per Sjöberg som formand, afholdt to møder i 1998.
The Safety Working Party (SWP), chaired by Dr Per Sjöberg met twice in 1998.
Arbejdsgruppen ydede rådgivning i prækliniske spørgsmål og sikkerhedsrelaterede emner og deltog i en række tilfælde i forberedelsen af CPMP´s videnskabelige rådgivning.
The working party gave special advice on pre-clinical and safety issues and was involved on a number of occasions in the preparation of scientific advice.
Arbejdsgruppen beskæftigede sig navnlig med behovet for og omfanget af testning af lægemidlers cancerfrembringende potentiale i forbindelse med ICH - guidelines (ICH topic S1A: behovet for undersøgelse af lægemidlers cancerfrembringende potentiale, ICH topic S1B: testning af lægemidlers cancerfrembringende potentiale).
In particular the working party addressed the need and extent of testing carcinogenic potential in relation to the ICH guideline (ICH topic S1A: need for carcinogenicity studies of pharmaceuticals, ICH topic S1B: testing for carcinogenicity of pharmaceuticals).
SWP deltog sammen med BWP i udarbejdelsen af vejledningsnotater vedrørende DNA- vacciner og genterapi.
The SWP, in cooperation with the BWP, was involved in the preparation of the DNA vaccine and gene therapy related notes for guidance.
SWP afholdt i samarbejde med en ad hoc- gruppe vedrørende nye metoder til testning af lægemidlers cancerfrembringende potentiale en workshop under ledelse af dr.
In conjunction with the SWP, an ad hoc group on new methods for testing the carcinogenic potential of medicinal products was held, chaired by Dr Per Sjöberg.
Denne workshop bekræftede EU´s hidtidige holdning, nemlig at der på indeværende tidspunkt ikke foreligger tilstrækkelige oplysninger til, at det er muligt at forudsige eller vejlede om, hvilke af de nye modeller der er bedst egnet til et givet lægemiddel.
This workshop confirmed the EU position held earlier, namely that there is insufficient information at present to predict or offer guidance on which of the new models may be most suitable for a particular medicinal product.
De nye modeller vil blive evalueret, når der er indhøstet flere erfaringer.
The new models will be evaluated when more experience has been gained.
Følgende dokumenter blev vedtaget eller sendt til høring af CPMP i 1998:
The following documents were adopted or released by the CPMP for consultation in 1998:
Referencenummer CPMP/ SWP/ 160/ 98
CPMP/ SWP/ 160/ 98
Konceptdokument Immunotoxicity and the need to update the notes for guidance on repeat dose toxicity and on non - clinical local tolerance testing of medicinal products
Immunotoxicity and the need to update the notes for guidance on repeat dose toxicity and on non-clinical local tolerance testing of medicinal products
Reference Number CPMP/ SWP/ 997/ 96
CPMP/ SWP/ 997/ 96
Guidelines Pre- clinical evaluation of anticancer medicinal products
Pre-clinical evaluation of anticancer medicinal products
Status Vedtaget i juli 1998
Adopted in July 1998
CPMP/ ICH/ 300/ 95 (S4)
CPMP/ ICH/ 300/ 95 (S4)
Duration of chronic toxicity testing in animals (rodent and non- rodent toxicity testing)
Duration of chronic toxicity testing in animals (rodent and non-rodent toxicity testing)
Vedtaget i november 1998
Adopted in November 1998
CPMP/ SWP/ 112/ 98
CPMP/ SWP/ 112/ 98
Safety studies for gene therapy products.
Safety studies for gene therapy products.
This is an annex to the Note for guidance on gene therapy product quality aspects in the production of vectors and genetically modified somatic cells.
This is an annex to the Note for guidance on gene therapy product quality aspects in the production of vectors and genetically modif ied somatic cells
Sendt til høring i januar 1998
Released for consultation in January 1998
CPMP´s ad hoc- grupper
Ad hoc CPMP groups