European Commission Publishes New Good Manufacturing Practice Measures for Medicines

• 02/10/2017
• Articles

On 16 September 2017, the European Commission published two measures that update good manufacturing practice (or “GMP”) for medicines for human use in the EU.

The first measure is Commission Directive 2017/1572 (EU) supplementing Directive 2001/83/EC as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (O.J. (2017) L 238/44). Directive 2017/1572 will apply to all medicinal products for human use manufactured in or imported into the Union, including medicinal products intended for export. It will replace Directive 2003/94/EC on a date that still has to be determined but that will not be earlier than 1 April 2018.

The second measure is Commission Delegated Regulation (EU) 2017/1569 supplementing Regulation (EU) No 536/2014 by specifying principles of and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections. This Regulation is required by Clinical Trials Regulation (EU) 536/2014 and tackles the specific challenges posed by investigational medicinal products such as the absence of fixed routines; the variety of clinical trial designs and packaging designs; the requirement of randomisation; and the need to disguise the identity of the investigational medicinal product. In addition, the toxicity, potency and sensitising potential of investigational medicinal products may not yet be fully understood at the time of the trial and there is an obvious need to minimise all risks of cross-contamination. Regulation (EU) 2017/1569 will enter into force on a date that has yet to be determined but that equally will not be earlier than 1 April 2018.

Both measures are attached for your information.