Essential Medicines and Biologicals
Medicines and Health Technologies
Regional Health Sector and Regulatory Experts Meet at Seventh PANDRH Conference
National health authorities, health experts, civil society and pharmaceutical industry representatives, and national regulatory authorities (NRAs) from the Region of the Americas and other parts of the world met in Ottawa, Canada, from 5 to 7 September 2013 for the Seventh Conference of the Pan American Network for Drug Regulatory Harmonization (PANDRH). The purpose of the conference was to promote drug regulatory harmonization, strengthen regulatory capabilities and convergence, promote health surveillance, and coordinate evaluation of a strategic development plan for the Network.
The theme of the three-day meeting was “16 years promoting good regulatory practices in the Region of the Americas,” and participants stressed the need for a governance mechanism that can effectively respond to changes in health regulations, promote medicines regulation through innovative research, and implement strategies that promote access to good-quality, safe, and effective medicines and health technologies. The participants also noted the importance of developing mechanisms for information exchange to facilitate the work of regulatory agencies and make health products safer through ongoing cooperation among countries.
The main topics of the conference included improving network governance; active NRA participation in efforts to foster convergence and drug regulatory harmonization; adopting strategies and mechanisms for drug regulatory harmonization and convergence; strengthening competencies in good regulatory practices and regulatory science; and promoting the sharing of regulatory experiences and know-how among NRAs.
Sessions were also held on the Region’s progress and challenges in the fields of medicines surveillance and patient safety, counterfeit medicines, biotherapy products, and the regulation of medical devices and bioequivalent medicines.
At the end of the meeting, the participants agreed on the need to establish a new governance structure for PANDRH that reorganizes the Network’s operations and coordinates its work with other international drug regulatory harmonization and convergence initiatives. Another proposed agreement was the adoption of a systematic mechanism for setting priorities based on a periodic analysis of the situation and needs of NRAs.
The participants also recommended that a competency-based curriculum and comprehensive capacity-building plan for the staff of regulatory agencies be developed that reflects the Region’s different realities and diversity, and that streamlined information exchange be established between network members and other regulatory agencies through knowledge management instruments to support the new PANDRH strategic plan for 2014-2020.
VII PANDRH Conference: Important documents
- Opening Remarks - James Fitzgerald - PAHO/WHO
- Strategic objectives sessions
- Thematic sessions
- VII PANDRH Conference: Recommendations and next steps