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Regulatory News | 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