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Marketing Authorization Procedure and Their Requirements for Pharmaceutical Products in European UnionBy Rasheed A., Dixit M., Charyulu R.N., Rahman F., Daniel S.
Abstract: Developing a new drug requires a great amount of research works in chemistry, manufacturing, controls, preclinical science and clinical trials. European Union (EU) is a hub of political and economic union of 28 member states (MS) and extensive amount of effort was spent by the EU Commission, the EU parliament, the European Medicines Agency (EMEA) and the national authorities in updating the EU regulatory environment for pharmaceuticals and granting marketing …
Published in Research & Reviews: A Journal of Drug Formulation, Development and Production · Vol. 1, Issue 3, 2014 · pp. 8–15 Read article →