Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at firstname.lastname@example.org if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Posted 02 September 2015 | By Zachary Brennan
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:
Tags: GMP, investigational products for human use, clinical trials, European Commission
Regulatory Focus newsletters
All the biggest regulatory news and happenings.