FDA and Pan American Partners Work to Strengthen Regulatory Systems

By: Charles Preston, M.D., MPH

Regulatory systems are essential for good health care because they ensure safe, high quality and effective medicines. However, these systems must be strengthened in many parts of the world — a subject that is a core effort of the Pan American Network for Drug Regulatory Harmonization (PANDRH).

Charles PrestonI had the privilege of representing the FDA at a recent steering committee meeting, and I am happy to report that this network, which includes countries from all over the Western Hemisphere, is ready to adapt to new challenges like globalization, and improve its effectiveness.

In the past, the network has concentrated on upgrading regulatory standards by developing guidances and strengthening regulator capacity through training. There have been many successes, including multiple guidances issued and numerous trainings conducted.  However, there is a recognition that these efforts need new focus.

Thus, PANDRH has a strategic plan for modernizing its activities.

Rather than only developing region-specific guidances, it proposes improving standards by leveraging the work of global bodies, such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, and the Pharmaceutical Inspection Cooperation Scheme.

To strengthen capacity for oversight, PANDRH members will work to develop and implement a globally agreed upon set of regulator competencies, and use this to drive curricula and training objectives in the region. By doing this, the regulatory workforce can be professionalized, which will strengthen it for the future.

Another new emphasis will be to use evidence to help set priorities. The secretariat and PANDRH member states will now analyze data from evaluations of regulatory systems in the region to decide on future activities and benchmark success.

The importance of these changes is obvious: in today’s world of global manufacturing, trade and consumption, national regulators must be truly professional and able to implement global standards.

These are exciting developments that portend an auspicious new direction for PANDRH. FDA will continue its active engagement in the network’s efforts. They are essential to achieving a world in which everyone has access to safe, high quality and effective medical products that can protect or restore human health.

Charles Preston, M.D., MPH, is a medical officer in FDA’s Office of International Programs

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