New FDA Plans Intend to Ensure Drug Safety for Imported Products

GMP News
21 May 2008

New FDA Plans Intend to Ensure Drug Safety for Imported Products

Dr Janet Woodcock, FDA CDER (Center for Drug Evaluation and Research) Director, presented the draft of the "FDA Globalization Act• for drug safety to the U.S. House Representatives. In her presentation she particularly covered how the authority intends to face the increasing challenges in a global drug market in the future. The Act's core document is the "Action Plan for Import Safety". This plan was ordered by President Bush and developed by representatives of 12 US authorities and departments - with the goal to ensure the quality of drugs that are completely or partly produced outside the USA and imported into the country.

Following are listed some of the most important items:

• Additional Inspections
Inspections conducted by the FDA are still in the centre. For that reason the authority plans on increasing the number of so-called "pre-approval• inspections. It plans to conduct 500 PAIs in 2009 (in comparison: 332 in the fiscal year 2007). By adding national and international investigators, the FDA also plans on increasing other inspection activities as well, like conducting more routine and "for cause• inspections.

• "Beyond our Borders Initiative"
This initiative actually builds the core of the "Action Plan for Import Safety". It is structured in several planned activities and proposals. One part of the initiative is to increase FDA presence abroad. In China, for instance, the authority is preparing the setup of an office full speed. A staff of 13 (eight of them are directly employed by FDA) is supposed to improve cooperation and to increase the number of inspections as well as to train Chinese inspectors.

Another idea is to increasingly analyse inspection reports from foreign authorities. For that purpose the FDA already signed 30 non-disclosure agreements with authorities from several countries. The reports are not supposed to replace own inspections, but rather to help gain important information and set priorities. For this the authority also plans on taking advantage of certificates from third parties. These certificates can be issued by a foreign country's authority, but also by independent, accredited organisations.

• Improved IT Structure
There are several approaches for improving the support for FDA's work through enhanced IT systems. They include the establishment of new databases and a better harmonisation of the various systems.

• Expanded Lab Capacities
The capacities are supposed to be expanded, including the development of faster analysis methods. They are also supposed to be applied directly at customs or port of entry. That way, the boarder is supposed to become an integral part of the new concept. Products can be processed, controlled and refused whenever appropriate.

• Track-and-Trace Systems
FDA still plans on controlling the complete drug supply chain, preferably electronically ("e-pedigree").


To realise all of what is planned, it is necessary to generate new competencies. The FDA already addressed this issue. Now it remains to be seen in what detail the proposed items can be realised. The first steps are done, and the build-up of staff is progressing. It can be expected that the additional inspections will primarily concentrate on facilities in Southeast Asia. However, European sites will also further be inspected regularly though. Somewhat critical are the Food & Drug Administration's activities on the boarder. It is not mentioned, for instance, how necessary storage conditions are maintained in a case of delay. Unfortunately the pharmaceutical industry is most likely supposed to develop own strategies here.

Dr Woodcock's complete presentation is available in the Internet at:

Prepared by:
Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)

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