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Non-EU APIs a concern says EMA in 2015 Roadmap

By Gareth Macdonald , 05-Jan-2011
Last updated on 07-Jan-2011 at 14:01 GMT

The European Medicines Agency (EMA) has highlighted the quality APIs manufactured outside the EU as an area of concern in the draft 2015 road map it unveiled this week.

In the document , which discusses the impact of globalisation on the drug industry, the agency suggests sourcing active pharmaceutical ingredients (API) internationally creates the “potential for substandard material to enter the supply chain.”

It goes on to cite problems with contaminated heparin imported from a manufacturer in China, which was responsible for a number of deaths worldwide, as well as a number of other high profile incidents as a basis for its concerns.

An EMA spokeswoman told in-PharmaTechnologist.com that: "In 2010 there were 14 Good Manufacturing Practice (GMP) non-compliance reports deposited in EudraGMP by the EU National Competent Authorities and 12 of these resulted from inspections outside of the EU [and] those 12, 8 were related to API manufacturers."

The comments follow European Directorate for the Quality of Medicines (EDQM) data showing that 24 of the 25 Certificates of Suitability (CEPs) it suspended or withdrew in 2010 for manufacturing reasons were for APIs made outside the EU.

Specifically, nine CEPs were for ingredients made by six companies in China, six were held by two companies in India, two from a Korean supplier and one from a manufacturer in Thailand. See EDQM site for details.

International collaboration

The key to addressing such quality issues for APIs and finished pharmaceutical products, according to the EMA, is greater collaboration with the 376 drug watchdogs outside Europe.

The agency said this approach will “improve the framework for the implementation of Good Manufacturing Practices (GMP) standards through capacity building,” and ensure inspection coverage based on sharing of planning and outcomes.

The EMA has already begun a joint inspection programme with the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA), results from which are due to be released this quarter .

Collaboration is hot topic for regulators this week. On Monday the US FDA finally became a member of the Pharmaceutical Inspection Convention and Pharmaceutical Co-Operation Inspection Scheme (PIC/S) after a five-year application process.

The US watchdog, which joined the scheme shortly before Ukraine’s State Inspectorate for Quality Control of Medicines (SIQCM), said membership means it is “sitting at the same table with other agencies that are looking at [the pharma industry’s] products and your procedures.”

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