European Commission Won't Pursue Directive for Excipient GMPs

June 11, 2009
Patricia Van Arnum

Patricia Van Arnum was executive editor of Pharmaceutical Technology.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The European Commission's (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients.

The European Commission’s (EC) Directorate-General for Enterprise and Industry (EC-DG Enterprise) announced last week that it will not continue preparing a commission directive on good manufacturing practices (GMPs) for certain excipients. A 2001 EC directive (Article 46(f), Directive 2001/83/EC as amended by EC-Directive 2004/27/EC) called for the EC to develop a list of excipients that would be subject to GMPs.

GMP standards for excipients have been considered and discussed between the EC-DG Enterprise and interested stakeholders for several years. The EC-DG Enterprise reached its decision following a public consultation, which revealed concerns by stakeholders and member states regarding the lack of flexibility in such a directive.

“The results of the consultation suggest a balanced approach for requiring GMP for excipients within the concert of legal requirements on manufacturing and quality control in the legal pharmaceutical framework,” said the EC-DG Enterprise in a prepared statement. “The requirement for selected GMP conditions to be applied for excipients seems to be justified both from a public health and a business perspective if linked to a formalized decision-making process by the manufacturer of the medicinal product.”

The EC-DG Enterprise added that such a decision-making process should be based on internationally agreed concepts and quality risk-management criteria as specified in the International Conference on Harmonization’s Q9 Quality Risk Management guideline and the

. It also specified that the 2001 EC directive would have to be amended before such a concept could be further pursued. 

The EC-DG Enterprise’s decision not to develop a directive on excipient GMPs follows the release of results from an

and related

in December 2007. As part of that study, the EC consulted manufacturers and users of certain categories of excipients on various policy options. These options included maintenance of the status quo, legislation (i.e., a commission directive on GMP requirements), GMP guidelines, risk-management tools, and self regulation. The study found that although the industry was concerned about the cost implications of more regulation, there was general agreement that excipients should be manufactured to GMP standards.

See related stories:

Regulation for Excipients is Brewing Across the Atlantic

EC Plans Directive on GMPs for Excipients