Resolution No. 435 of 2006 on the Egyptian Regulation for Good Fabrication Methods of Animal Preparations, Serums and Vaccinations.

The aim of this Resolution is to regulate and control animal preparations, serums and vaccinations. It is consists of 4 articles and the National Guidelines and Regulation for Good Clinical Practice (GCP). Article 1 adopts the GCP of the World Health Organization (WHO) for good fabrication methods of animal preparations, serums and vaccinations as an Egyptian Regulation. The development of the aforementioned Regulation shall be carried out according to the amendments issued and decided by the World Health Organization (art. 2). Article 3 entrusts the National Authority for Research and Control of Animal Preparations to print and publish the aforesaid Egyptian Regulation. The National Guidelines and Regulation for Good Clinical Practice (GCP) composed of 6 Chapters related to the following matters: principles of GCP; protection of trial subjects and consultation of ethics committees; sponsor; investigator; clinical trial protocol and protocol amendment (s); and definition of clinical trials.