13/14 March 2024
The EU Commission has published a new public consultation on an Implementing Act on Principles and guidelines on good manufacturing practices for medicinal products for human use.
The reason is that once Regulation (EU) No 536/2014 on clinical trials becomes applicable, manufacture and import of Investigational Medicinal Products (IMPs) for the use in clinical trials carried out under that Regulation cannot follow GMP for IMPs set out in Directive 2003/94/EC. They then have to be manufactured or imported under regulations laid down by the Delegated Act or other specified regulation. It is therefore necessary that Directive 2003/94/EC is revised by a new Implementing Directive on principles and guidelines of good manufacturing practice for medicinal products for human use (without IMPs).
The EU Commission states that because "good manufacturing practice for medicinal products for human use already exists and is generally well-functioning, there is no need to reinvent the wheel". So the GMP related consultation documents carry over elements set out in Directive 2003/94/EC relating to medicinal products for human use. GMPs for advanced therapy medicinal products will be introduced with a new provision.