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EMA/129698/2012: Concept paper on extrapolation of efficacy and safety in medicine development. [10] FDA-2015-D-1376: Leveraging existing clinical data for extrapolation to pediatric uses of medical devices. Guidance for Industry and Food and Drug Administration Staff. [11] ICH E5 (R1): Ethnic factors in the acceptability of foreign clinical ...
The WHO Smart Guidelines are part of a broader global trend of digitizing clinical guidelines to make them more actionable in healthcare systems. For example, the Centers for Disease Control and Prevention (CDC) in the United States developed the "Adapting Clinical Guidelines for the Digital Age" (ACG) initiative, which promotes a holistic ...
Volume 7 - Guidelines. Volume 8 - Maximum residue limits. Concerning Medicinal Products for Human and Veterinary use: Volume 4 - Good Manufacturing Practices. Volume 9 - Pharmacovigilance. Miscellaneous: Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03)
In February 2015, the "EMA announced it would no longer accept paper application forms for products applying to the centralized procedure beginning 1 July 2015." [ 11 ] The EMA verified on that date that it would no longer accept "human and veterinary centralised procedure applications" and that all electronic application forms would have to be ...
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 ).
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained.
It was developed by the European Medicines Agency (EMA, Europe), the Food and Drug Administration (USA) and the Ministry of Health, Labour and Welfare (Japan) starting at World Health Organization International Conference of Drug Regulatory Authorities (ICDRA) at Paris in 1989. [1]
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]