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Eudralex,The Rules Governing Medicinal Products in the European Union, European Communities Commission. Directorate-General for Industry, Pharmaceuticals and Cosmetics. Vol. 1: Pharmaceutical legislation: medicinal products for human use.
The European Union Clinical Trials Regulation (regulation (EU) No 536/2014) is the legislation relating to the conduct of clinical trials of investigational medicinal products within the European Union. The regulations repealed the previous legislation, namely the clinical trials directive and came into force on 31 January 2022. [1]
The European regulatory authorities update the database continuously and expect it to grow extensively over the next few years as more “GMP certificates are imported each year.” [2] The database serves as a quick reference for checking the good manufacturing practice (GMP) of a potential contract manufacturer.
European Union: In the EU, Good Clinical Practice is backed and regulated by formal legislation contained in the Clinical Trial Regulation (Officially Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC). [3]
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate and partial agreement of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia (an international treaty adopted by the Council of Europe in 1964: ETS 50, [2] Protocol [3]).
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages , [ 1 ] cosmetics , [ 2 ] pharmaceutical products , [ 3 ] dietary supplements , [ 4 ] and medical devices . [ 5 ]
The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or European Medicines Evaluation Agency ( EMEA ).
The European Journal of Pharmaceutical Sciences is a peer-reviewed medical journal and the official journal of the European Federation for Pharmaceutical Sciences. It publishes research reports, review articles, and scientific commentaries on all aspects of the pharmaceutical sciences. The abstracts of the biennial European Congress of ...