CPMP-Note for guideline on Harmonization of requirements for influenza vaccine欧盟-流感疫苗标准指南.docxVIP

The European Agency for the Evaluation of Medicinal ProductsHuman Medicines Evaluation Unit 12 March 1997 CPMP/BWP/214/96 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS(CPMP) NOTE FOR GUIDANCE ON HARMONISATION OF REQUIREMENTSFOR INFLUENZA VACCINES DISCUSSION IN THE BIOTECHNOLOGY WORKING PARTY(BWP) March 1996 TRANSMISSION TO THE CPMP July 1996 TRANSMISSION TO INTERESTED PARTIES July 1996 DEADLINE FOR COMMENTS January 1997 RE-SUBMISSION TOTHE BWP March 1997 RE-SUBMISSION TO THE CPMP March 1997 APPROVAL BYTHECPMP March 1997 DATE FOR COMING INTO OPERATION April 1997 7 Westferry Circus, Canary Wharf, London E14 4HB, UKSwitchboard: (+44-171) 418 8400 Fax: (+44-171)418 8551E_Mail: mail@ /emea.html HARMONISATION OF REQUIREMENTS FOR INFLUENZA VACCINES (CPMP/BWP 口 14/96) Immediate package Outer packaging Package leaflet YEARLY CHOICE OF INFLUENZA VIRUS STRAINS FOR VACCINES WHO has three international influenza centres (at the National Institute for Medical Researchin Mill Hill UK; and at the Centers for Disease Control in Atlanta, USA and at CSL Ltd,Parkville, Australia), which are assisted by national laboratories, designated by WHO. Thenational laboratories isolate viruses and then refer them to an international centre for detailedantigenic analysis. Reports are regularly sent to WHO in Geneva. Once a year, in mid-February, a meeting of WHO experts takes place in Geneva, leading to arecommendation on the influenza A and B virus variants which should be used for theproduction of vaccine for the coming season, but there remains very broad flexibility withinthis recommendation. The WHO recommendations are aimed worldwide and therefore need tobe adapted to the epidemiological situation of the European Union (EU). The predominantinfluenza viruses are believed to be similar from one Member State of the EU to another,There is thus little scientific justification for different composition of vaccines throughout theEU. As from 1992, a meeting of EU experts will h