EC Plans Directive on GMPs for Excipients

Brussels, Belgium (Mar. 22)-The European Commission’s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium, http://ec.europa.eu/index_en.htm) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

DG Enterprise and Industry will share the results of the questionnaire with Europe Economics (London, UK, www.europe-economics.com), an external contractor, for analysis. The results will then be written in a report, with parts made available to the public. The report will not reveal information that will allow retrieval of company-specific data.

A draft entitled “Specific Conditions of the Application of the Principles and Guidelines of GMP for Certain Excipients” is planned for publication as a possible basis for the GMP directive.

The questionnaire should be completed by July 30, 2007 and can be accessed by visiting http://ec.europa.eu/enterprise/pharmaceuticals/index_en.htm