International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making

The deepening channels of international information sharing are having an increasing impact on inspection decision-making and activities at FDA.

Regulatory agencies are being more open with each other and sharing inspection results as a way to improve both agency efficiency and industry compliance. Joint inspections, including initiatives between the US and Europe for finished products and the US, Europe and Australia for APIs, are also enhancing interagency linkages and increasing the comfort levels needed to share sensitive information.

The establishment of FDA offices in foreign countries is another manifestation of the deepening channels through which the inspection-related information sharing and decision making are flowing (IPQ "In the News" September 7 companion story).

At the DIA Annual Meeting in Chicago in June, CDER Office of Compliance Division of International Drug Quality Acting Director Carmelo Rosa provided recent examples of how FDA inspection processes are being affected by interagency cooperation.

Rosa’s examples illustrate the process and the outcomes of what the agency calls “desktop reviews” – using available information to help determine foreign inspection priorities. The reviews now include consulting with other regulatory agencies and examining their reports as inputs to the decision-making process. Rosa noted that his division performed 13 such reviews in 2009, 22 in 2010 and had expanded to 37 during the first six months of 2011.

Rosa explained that, as part of desktop reviews, FDA monitors the European Directorate for the Quality of Medicines (EDQM) database looking at approvals and suspensions of “certificates of suitability” (CEPs). CEPs are granted by EDQM to API, starting material and excipient manufacturers based on dossier reviews against the European Pharmacopeia and inspections against EU GMPs, and when approved, allow products to be sold in the EU.

A CEP may be issued before or after an EDQM inspection. When an inspection shows a lack of adherence to EU GMPs or a major deviation from the filed dossier, the certificate – often referred to as a license – can be revoked. CEPs are generally also revoked if the firm refuses to allow an inspection.

Between 2004 and 2010, 80% of EDQM’s CEP inspections were conducted in India and China. In 2010, 34 inspections were conducted with six sites found noncompliant, and four sites (including three in China) refusing inspection, resulting in their CEPs being suspended.

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Source: This article is taken from the IPQ (International Pharmaceutical Quality Journal).
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