Mixed response to EC plan to extend Directive 2003/94/EC to APIs

By Gareth Macdonald

- Last updated on GMT

EC API regulations plan get mixed pharma response

Related tags: Active pharmaceutical ingredients, Pharmacology, Pharmaceutical drug

The EC plan to extend drug GMP guidelines to APIs has met with a mixed response from industry groups, drugmakers and API manufacturers with some - like DSM and CEFIC – asking for clarification on the future of EudraLex Volume 4 Part II.

The proposal – published for comment earlier this year​ – is that good manufacturing practices (GMP) guidelines for drugs - Directive 2003/94/EC - be applied to active pharmaceutical ingredients (API) to ‘bring coherence’ to the regulations and stop falsified medicines entering European supply chains.

Netherlands-based supplier DSM - one of the 27 groups to comment publically​* – agreed with the idea in principal, but raised some concerns​ about how the move would impact the current guidelines on API quality covered in EudraLex Volume 4 Part II​.

It is unclear however if it is the intention of commission to suppress Part II of the GMP guidelines, and apply the requirements of Part I to APIs. We would strongly oppose to such a change, as this would create a disharmony between the ICH regions, increase the manufacturing cost for API​.”

The firm argued that such a cost increase would be more of an incentive for unscrupulous suppliers to “avoid the higher costs of compliance, and penetrate aggressively into a higher cost market.”

The European Chemical Industry Council’s (CEFIC) Active Pharmaceutical Ingredients Committee (APIC) had a similar take​. The group said that: “It appears from comments from our different members that it is not clear if EudraLex  – Volume 4, Part II, would still apply to Active Substances as the “detailed guidelines.​"

The Society of Chemical Manufacturers and Affiliates’ (SOCMA) Bulk Pharmaceuticals Task Force (BPTF) went further​, suggesting that any changes to current API GMP guidelines would lead to confusion across the supply chain.

The principles of ICH Q7 align with Directive 2003/94/EC, but there are substantive differences. ICH Q7 has served the pharmaceutical industry and European public well. The concept paper fails to identify any shortcoming of this quality standard, nor explain why it should be abandoned​.”

Like DSM, the BPTF also raised concerns about the impact on the cost of API production, suggesting that higher costs may force some generic producers out of the market. This, it believes, would increase the amount of actives sourced in countries which have poor quality oversight, potentially enabling substandard APIs to enter the European market.


Other parties supported the plan with Bayer​ joining Germany’s Ministry of Health and Environment​, China’s State Food and Drug Administration (SFDA​), the European Directorate for the Quality of Medicines & Healthcare (EDQM​) all backing the idea of extending Directive 2003/94/EC to APIs to a greater or lesser extent.

The European Commission (EC) has not yet issued a response to any of the comments.

* Israeli generic drugmaker Teva Pharmaceutical Industries asked for its response not to be published.

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