Regulatory Requirements for Human Biopharmaceuticals, European Community

Abstract

Abstract The European Union (EU), consisting of 27 member states and supporting a population of almost 500 million, now represents the world's single largest developed pharmaceutical market. Throughout the 1980s and early 1990s, a series of pharmaceutical laws were enacted throughout the EU, which effectively harmonized pharmaceutical regulations within all member states. This legislation, along with associated guidelines and other interpretative documents, collectively comprise the 10‐volume “rules governing medicinal products within the EU”, which is published by the European Commission. These laws also paved the way for the establishment of the European Medicines Agency (EMEA), charged with managing and coordinating the new EU‐wide drug regulatory system. The EMEA assesses new marketing application for biotech drugs via a centralized system. The agency, through its Committee for Medicinal Products for Human Use (CHMP), formulates an opinion on the application within an active evaluation time frame of 210 days. This opinion is then transmitted to the European Commission, the EU body with the legislative power to actually grant marketing authorization. The commission has 90 days in which to examine the EMEA opinion and make a final decision. Thus, the overall drug approval process is undertaken within 300 days of active evaluation. In addition to playing a central role in assessing new biotech drugs for marketing authorization, the EMEA also plays various roles in other activities pertinent to a drug's life cycle. This includes the drug development process, pharmacovigilance, and manufacturing. Much of the day‐to‐day activities concerning the latter regulatory issues, however, are undertaken within the national regulatory bodies of the individual EU member states.