Washington, D.C., September 30, 2010 (PAHO) — Health officials from throughout the Americas said they would work with the Pan American Health Organization (PAHO) to strengthen the capacities of their national regulatory authorities to guarantee the quality, safety and efficacy of pharmaceutical products.
The officials endorsed a PAHO proposal on "Strengthening of the National Regulatory Authorities of Medicines and Biologicals" during the Organization's 50th Directing Council meeting, which is taking place in Washington, D.C., this week.
Effective regulatory systems are important to prevent the circulation of harmful or ineffective medicines, vaccines and other biologicals on the market. The specific responsibilities of regulators range from authorizing clinical trials and approving products for the market, to inspection and licensing of manufacturers and distributors, post-marketing surveillance, and oversight of advertising and the rational use of medicines.
To be effective, regulatory systems must have adequate legal frameworks, standards and policies. The PAHO proposal will help countries strengthen their regulatory systems in these and other key areas through self-assessments, the establishment of reference institutions, and sharing of information and experiences.
In approving the proposal, PAHO member countries agreed to:
- Strengthen and evaluate their own drug regulatory systems by assessing the performance of their essential functions, as defined by the World Health Organization (WHO).
- Use the process of qualification and designation of "regulatory authorities of regional reference" to strengthen their own systems' performance of essential regulatory functions.
- Promote dissemination of information on the results and processes of regulation and oversight of medicines, biologicals, and other health technologies.
- Actively participate in the Pan American Network for the Drug Regulatory Harmonization (PANDRH).
The countries called on PAHO to support their efforts by:
- Establishing drug regulation and promoting harmonization mechanisms such as PANDRH.
- Developing and implementing a process for evaluating the performance of national regulatory authorities in terms of the basic functions established by WHO.
- Creating mechanisms to provide technical training for national regulatory authorities.
- Promoting interaction and technical cooperation among countries.
The PAHO Directing Council meets each year to set priorities for Pan-American cooperation in health and to guide PAHO's technical cooperation programs in its Member States.
PAHO was established in 1902 and is the world's oldest public health organization. It works with all the countries of the Americas to improve the health and quality of life of the people of the Americas and serves as the Regional Office for the Americas of the World Health Organization (WHO).
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