FDA To Work With Pan American Partners To Regulate Drugs

Representatives from the Food and Drug Administration recently attended a steering committee meeting of the Pan American Network for Drug Regulatory Harmonization (PANDRH). PANDRH is a continental forum that seeks to harmonize drug regulation in Pan America, including North America, Central America, South America, the Caribbean, and the sub-regions. The organization has recently announced its commitment to improving its effectiveness in response to globalization.

Charles Preston, M.D., MPH, in the FDA’s Office of International Programs, wrote in the “FDA Voice,” “These are exciting developments that portend an auspicious new direction for PANDRH. The FDA will continue its active engagement in the network’s efforts.”

PANDRH Past Efforts

PANDRH states its mission, objectives, and strategies in its Norms and Regulations document. The network’s past efforts have focused on developing guidance for industry and improving regulator training. While many guidances have been published and many training sessions have been performed, the agency acknowledges that its efforts need new focus. 

PANDRH Modernization

PANDRH outlined its plan at the FDA-attended meeting. While the region-specific guidances have been well received, the agency now feels that it may be more effective to leverage the works of other global regulatory bodies. Those entities include the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the Pharmaceutical Inspection Cooperation Scheme.

To strengthen its regulator training programs, PANDRH will develop a set of regulator competencies that are globally agreed upon by members. The agency hopes that new standards in training will professionalize the regulatory workforce.  PANDRH also commits to using data and evidence to drive decision making. PANDRH member states will be analyzing data from other regulatory systems in the region to set priorities.

PANDRH Members

PANDRH began in 1999 and was officially recognized by the Pan American Health Organization (PAHO) in 2000. PANDRH members include all of the drug regulatory authorities in the Western Hemisphere. Other members are economic groups, such as CARICOM, MERCOSUR, TLCA, Latin American Association for Integration (ALADI), and the Andean Community. Additionally, academic groups are represented as well as physician groups and community groups. Members fund the agency and/or participate in biennial Pan American conferences, steering committee meetings, and technical working groups.