The European Commission’s long-awaited Delegated Regulation on Good Manufacturing Practice (GMP) principles and guidelines for active substances for medicinal products for human use was published in the EU’s Official Journal on November 25, 2014. The Regulation (available here) will apply from May 25, 2015, and follows the revision of several key parts of the European Commission’s GMP guidelines (see here) earlier in 2014.
Implementing rules on GMP for active substances have been under preparation since 2011, when the Falsified Medicines Directive (2011/62/EU) amended the Medicinal Products Directive (2001/83/EC) and introduced new, stricter GMP and Good Distribution Practice (GDP) requirements for active substances, as described in previous Sidley Updates (see here,here and here). Initially the European Commission intended to extend the scope of the existing EU GMP Directive on medicinal products (2003/94/EC) to active substances, but a public consultation (see here) and discussions with stakeholders led to the preparation of a separate Regulation.
The new Regulation is legally binding and imposes various requirements on manufacturers of active substances with respect to quality management, documentation practices, laboratory controls, measures to prevent cross-contamination, complaint investigations, product recalls, as well as the suitability of equipment, buildings, facilities, personnel and materials used by the manufacturer. The Regulation specifically provides that an active substance can only be placed on the market after it has been released for sale by the manufacturer’s quality unit.
The Regulation supplements existing European Commission guidance on GMP requirements for active substances (API GMP Guidance), a revised version of which was published in August 2014 (see here) and became applicable on September 1, 2014. The revision of the API GMP Guidance followed the publication in 2014 by the European Commission of new versions of several chapters of the EU GMP guide related to finished medicinal products, including on Personnel (Chapter 2), Premises and Equipment (Chapter 3), Production (Chapter 5), Quality Control (Chapter 6), and Complaints and Product Recalls (Chapter 8).
The broad range of revisions to the EU’s GMP rules and guidelines for active substances and finished medicinal products require careful review by manufacturers to ensure compliance in an increasingly strict and global enforcement environment. Stakeholders should also carefully review their compliance with the EU’s stricter GDP requirements, and monitor the expected publication of new EU guidelines on GDP requirements for active substances.