Good Clinical Practice Directive

Directive 2005/28/EC laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorization of the manufacturing or importation of such products has been on 8 April 2005 by the Commission of the European Community adopted. With it, the principles and guidelines of good clinical practice (GCP ) for for human use, investigational medicinal products and lays down certain requirements for authorization of the manufacturing or importation of such products.

It is based on the Directive 2001/20/EC on the implementation of good clinical practice of the European Parliament and of the Council of 4 April 2001 on the approximation of laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal drugs, and in particular Article 1, paragraph 3, Article 13, paragraph 1 and Article 15, paragraph 5

It is divided into the following seven chapters:

  • Subject
  • Good Clinical Practice for the planning, conduct, recording and reporting clinical trials
  • Authorization of the manufacturing or importation of
  • As a continuous record for documentation ( Trial Master File ) and archiving
  • Inspectors
  • Inspection procedures
  • Final provisions
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