Implications for APIs in the European Falsified Medicines Directive - Pharmaceutical Technology

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Implications for APIs in the European Falsified Medicines Directive
Two industry groups offer perspectives on The European Falsified Medicines Directive.

Pharmaceutical Technology
pp. s44-s49

Supply-chain security
PharmTech: From an industry perspective, as regulatory and industry groups seek ways to fortify the pharmaceutical supply chain in an increasingly global environment, what are the implications in the outsourcing relationship, either from the perspective of a sponsor company (i.e., pharmaceutical company) or contract manufacturer/supplier?

APIC and EFCG: The sponsor company needs a contractor that it can trust to meet appropriate GMP standards in terms of product quality, quality culture, regulatory compliance with the laws of the country of product destination, and delivery at a price they are prepared to pay. Roles and responsibilities with respect to manufacture and distribution, including sub-contracting or use of third party distributors, should be clearly defined and understood by both parties. The contractor should be aware of the relevant regulations and should be able to comply with them. They must not fail their sponsor by delivering sub-standard products.

Initiatives from APIC and EFCG
PharmTech: Can you outline key recent activities of APIC and EFCG in 2012 and 2013 in response to the EU FMD implementation and other measures that affect API supply into the EU?

APIC and EFCG: APIC and EFCG have been very active opposite the EC during the implementation of the FMD. We have written letters and made face-to-face representations to the EC’s Directorate-General for Health and Consumers (DG SANCO) to point out the continuing risks to EU patients (we are all patients) and to the EU API manufacturing base (our members). The latter suffer unfair competition mainly from Asian API manufacturers, many of whose facilities fall well short of the EU-required GMP standard (ICH Q7) (10).

We have challenged the “loopholes” that remain within the FMD, which unless rigorously enforced by the various national regulatory authorities, will not prevent substandard APIs from continuing to enter the EU market, either as bulk API (requiring written confirmations) or through formulated products (where there is no separate check on APIs). We are pleased to note via DG SANCO that the national authorities in China and India have severely limited the number of sites for whom written confirmations are permitted. APIC and EFCG will continue to press for mutual recognition agreements with other countries (e.g., US, Japan, and Australia) that operate to the same GMP standards to help level the global playing field.

1. P. Van Arnum, Pharm. Technol. 37 (7) 62-63 (2013).
2. EMA, “Falsified Medicines,”, accessed July 16, 2013.
3. EC Directive 2011/62/EU, Falsified Medicines Directive (Brussels, July 2011).
4. EMA, “Falsified Medicines Directive: Imported Active Substances Need Written Confirmation to Guarantee GMP Standards,” Press Release (July 2, 2013).
5. EMA, “Key Deliverable of Falsified Medicines Directive Achieved,” Press Release (Apr. 8, 2013).
6. CEFIC, “About CEFIC,”, accessed July 16, 2013
7. APIC, “Objectives,”, accessed July 16, 2013.
8. EFCG, “Membership,”, accessed July 16, 2013.
9. European Commission website, Mar 27, 2013,, accessed July 27, 2013.
10. ICH, Q7 Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, Step 4 version (2000),, accessed July 22, 2013.


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