Role of the French drug licensing authority in the prevention of influenza pandemics.
The French Drug Agency is responsible for the control and delivery of batch release certificates. In the case of an influenza pandemic, the use of inactivated vaccines, produced according to well-established procedures and controlled according to the European Pharmacopea and FDA requirements, will be strictly dependent on the necessary delays for production and controls. Mutual recognition between the National Control Laboratories in Europe might help in shortening the delays. If new, inactivated vaccines are produced either on cell cultures or by using genetically modified organisms, and if live attenuated vaccines are needed, it would be suitable to organize ad hoc working groups and international collaborative studies in fields of both research and regulation.
National Influenza Reference Centre, Lyon, France.
M
M
Aymard
J P
JP
Cano
D000818:Animals; D002642:Chick Embryo; D003657:Decision Making; D004196:Disease Outbreaks / Q000517:prevention & control*; D004335:Drug and Narcotic Control; D005060:Europe; D005602:France; D006801:Humans; D007252:Influenza Vaccines / Q000592:standards / Q000600:supply & distribution; D007251:Influenza, Human / Q000453:epidemiology* / Q000517:prevention & control*; D007753:Laboratories; D008004:Licensure; D013678:Technology, Pharmaceutical; D015164:Vaccines, Inactivated / Q000592:standards / Q000600:supply & distribution
D007252:Influenza Vaccines; D015164:Vaccines, Inactivated