European Commission Seeks Industry Comment on New GMP Guidelines for Investigational Drugs

The European Commission is seeking comment from industry on two documents tied to the guidelines and principles of good manufacturing practices (GMP) for investigational drugs.

The commission notes that the current GMPs for medicinal products for human use from a 2003 directive are "generally well-functioning," so, "There is no need to reinvent the wheel."

The application of GMPs for investigational drugs is intended to ensure that clinical trial subjects are not placed at risk, and that the results of clinical trials are unaffected by inadequate quality, safety or efficacy arising from the unsatisfactory manufacturing of the drugs. The commission also seeks to ensure consistency between batches of the same investigational drug used in the same or different clinical trials and that changes to a drug are documented and justified.

The commission also includes a new provision in one of the consultation documents related to the use of GMPs for advanced therapy medicinal products (ATMPs), which include gene and cell therapies.

The requirements are meant to be adapted to the specific characteristics of ATMPs in accordance with a risk-based approach.

Industry and public comments are requested by 24 November and may be sent to:

• SANTE-D6-DA-GMP-IMP@ec.europa.eu on the consultation document on the Commission Delegated Act on principles and guidelines of good manufacturing practice for investigational medicinal products and on inspection procedures referring to "DA on GMP for IMP";
• SANTE-D6-GL-GMP-IMP@ec.europa.eu on the consultation document on detailed Commission guidelines on GMP for investigational medicinal products referring to "GL on GMP for IMP." The commission asks that commenters make reference to the lines or sections of the consultation document.