On 8 December 2017, detailed EU guidelines on good manufacturing practices (“GMP”) for investigational medicinal products for human use were adopted by the European Commission under the EU Clinical Trials Regulation. The document supplements the EU Delegated Regulation adopted in 2017 setting out GMP obligations for investigational medicinal products. The Delegated Regulation establishes a pharmaceutical
The U.S. Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), both part of the Department of Health and Human Services (HHS), issued final joint guidance on maintaining meeting minutes for Institutional Review Boards (IRBs).
Regulation No. 536/2014 repealed Directive 2001/20/EC of 4 April 2001 on the approximation of the laws, regulations, and administrative provisions of the member states relating to the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 products for human use. The main purpose of the Regulation is to harmonize and simplify
On 28 August 2015, the European Commission launched a public consultation on a new Implementing Act on principles and guidelines on good manufacturing practice (“GMP”) for medicinal products for human use. Article 46(f) of the Community Code relating to medicinal products for human use imposes on the holder of a marketing authorisation the obligation to comply