American, European And Australian Drug Regulatory Agencies Increasing Collaboration

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Main Category: Regulatory Affairs / Drug Approvals
Article Date: 03 Aug 2011 - 9:00 PDT


Two reports were released today by the FDA (USA), EMEA (Europe) and TGA (Australia) reporting on two pilot programs aimed at widening international regulatory collaboration so that medication quality and safety can be secured worldwide.

Good Clinical Practice (GCP) initiative - the report explains the extent of information-sharing and collaboration on clinical trials inspections. The FDA (Food and Drug Administration) and EMA (European Medicines Agency) exchanged over 250 documents concerning 54 different medications. Together, the two agencies organized 13 clinical trial inspections.

The Agencies say this is an example of better and more efficient use of finite resources, enhanced inspectional coverage and a better understand on how the other agencies work.

In a communiqué, the FDA wrote:

"It demonstrates how the agencies can work together to improve human subject protection and better ensure the integrity of data submitted as the basis for drug approvals."

Active Pharmaceutical Ingredients initiative - the report explains how successful information-sharing has been among EMA, TGA (Therapeutic Goods Administration, Australia), FDA, Ireland, Italy, the UK, France, Germany and EDQM (European Directorate for the Quality of Medicines & Healthcare).

During the two-year pilot phase, collaborators shared their surveillance lists and identified 97 sites they all had in common. This led to the exchange of almost 100 inspection reports and 9 collaborative inspections.

The FDA says it used those reports to decide whether to postpone or go ahead with its own inspections. More products were banned from being imported into the USA after the FDA was given negative data by European inspectors.

Deborah M. Autor, FDA deputy commissioner for Global Regulatory Operations and Policy, said:

"It is imperative that FDA work closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone. We are grateful to our European and Australian colleagues for their willingness to partner with us in these pilot programs. The pilots are important stepping stones toward further global regulatory collaboration."

The FDA says that these pilot programs form part of its global strategy to make sure imported products are safe and of the highest quality. The number of foreign drug manufacturing inspections organized by the FDA grew by 27% between 2007 and 2009. The FDA now has offices in China and India.

In a communiqué, the European Medicines Agency wrote:

"Both pilots involved the exchange of considerable amounts of information and the establishment of inspections carried out jointly by the agencies. This led to increased levels of understanding between the agencies, and a greater number of inspections of value to more than one authority.

Based on the positive experience in the two pilots, the agencies have agreed to continue with their collaboration on inspections, taking into account the experiences and lessons learned during the pilot phases."

Written by Christian Nordqvist
Copyright: Medical News Today
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