title: [Major milestones for European pharmaceutical policy].
abstract: Under the 1985 White Paper on the completion of the single market, several pharmaceutical harmonisation measures were unanimously adopted, in favor of biotech products and on pricing transparency, legal status of prescription, wholesale distribution and advertising. The European pharmaceutical harmonisation was extended to Norway and Iceland, to new accession member states and through major international conferences with the US and Japan (ICH). Starting in 1995, the European medicines agency has produced an efficient marketing authorisation system for new human and veterinary medicines. The system was extended to pediatric medicines and advanced therapies. The monitoring of drug adverse effects (pharmacovigilance) has been gradually strengthened.
authors: Fernand
authors: F
authors: Sauer
mesh_terms: D005060:Europe; D006077:Government Agencies / Q000266:history*; D049673:History, 20th Century; D049674:History, 21st Century; D007880:Legislation, Drug / Q000266:history*