Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper

At the end of January this year, the EU Commission published a concept paper entitled "Delegated Act on the Principles and Guidelines of Good Manufacturing Practice for Active Substances in Medicinal Products for Human Use". As a consequence of Directive 2011/62/EU on the prevention of the entry into the legal supply chain of falsified medicinal products a delegated act should lay down the principles of Good Manufacturing Practice for APIs in the form of a new directive. The EU Commission decided to simply extend the existing Directive 2003/94/EC ("Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use") to the provisions for API-GMP and made the concept paper named above available on their website for comment for a period of 12 weeks (see also our News from 25 January 2012).


In total, the Commission has received 28 comments from pharmaceutical companies, API manufacturers, authorities and associations. Overall, those comments can be summarised as follows: an extension of Directive 2003/94/EC to GMP provisions for APIs is rejected. The umbrella organisation of the European pharmaceutical industry - EFPIA (European Federation of Pharmaceutical Industries and Associations) says for example that the differences between GMP for medicines and for APIs are too big to be dealt with in the same document. Exception clauses should be described which would make the whole text nearly incomprehensible. Among other things, such exceptions would cover areas which are treated differently whether in API facilities or in pharmaceutical facilities like for example storage periods for documents and retain samples, complaints management, product recalls, reworking and re-processing, etc.


APIC, the organisation for European API manufacturers, points out that an extension of the Directive to API GMP would make the status of Part 2 of the EC GMP Guide (Eudralex, Vol. 4 Part II) very unclear. The APIC suggests clarifying in a future API GMP Directive that Part 2 of the Guide - which is based on the harmonised ICH Q7 Guideline - is still valid and that each time reference is made to "detailed guidelines", reference should be made to "Eudralex, Vol 4 Part II". Moreover, the APIC recommends that the GMP provisions for APIs should take the form of a Regulation. Unlike a Directive which must be first transposed into the respective national laws, a Regulation applies directly to all member states of the EU after it has entered into force. This would considerably facilitate the implementation of API GMP.


For further information please see the EU concept paper "Delegated Act on the Principles and Guidelines of Good Manufacturing Practice for Active Substances in Medicinal Products for Human Use" as well as the Commission website with the published comments.


Note: At the "15th APIC/CEFIC European Conference on Active Pharmaceutical Ingredients" on 9 - 11 November 2012 in Budapest, you will get first-hand information about the further development of GMP regulations for APIs.

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