Drug regulatory authorities from 120 countries exchange experiences in Brazil

Rio de Janeiro, Brazil, 28 August 2014 (PAHO/WHO) — Representatives of drug regulatory agencies from 120 Member States of the World Health Organization (WHO) are in Brazil this week for the 16th International Conference of Drug Regulatory Authorities (ICDRA), taking place in Rio de Janeiro on Aug. 24 to 29.

At the opening session of the conference, Dr. Carissa F. Etienne, Director of the Pan American Health Organization (PAHO), said, "Access to safe and efficacious medical products is one of the pillars of health systems, and there is no doubt that effective regulatory systems ensure the use of quality-assured medicines and promote and protect population health."

The ICDRA is being held in the Americas for the first time since 1980. It provides a forum for drug regulatory authorities from around the world to discuss trends and challenges, share solutions, and identify priority areas for action.

PAHO Director Etienne voiced concern about the challenges facing drug regulatory systems and the need to address existing weaknesses and lack of capacity. "The growing complexity of the pharmaceutical sector and the health technologies that are being presented for market authorization represent a challenge for national regulatory authorities, even for mature regulatory systems," she said. "Drug regulatory authorities do not always have the resources they need and sometimes do not have the support they require to do their job effectively."

Ensuring access to safe, effective and quality medicines and health technologies is critical to advancing universal health coverage, said PAHO Director Etienne. "This requires renewing international commitment and cooperation to develop national, regional, and global systems for the regulation and surveillance of medicines and other health technologies. This will require leadership from national regulatory authorities."

In May 2014, ministers of health attending the 67th World Health Assembly called for strengthening the performance of national drug regulatory authorities. At this week's conference, Minister of Health of Brazil Arthur Chioro recalled concerns raised at the World Health Assembly about safety and access to medicines and said it was essential to ensure that people have access to quality products they need to maintain good health.

Director General Dirceu Barbano of Brazil's National Agency for Health Surveillance (ANVISA) said this week's meeting will contribute to the harmonization of regulatory standards and improvements in quality, safety, and efficacy of medical products worldwide.

Strong regulatory systems are important to ensure that medicines are safe and effective for the population and that they are produced and distributed appropriately. PAHO/WHO helps countries strengthen capacity in this area through technical cooperation and by facilitating country-to-country collaboration.

PAHO, founded in 1902, is the oldest international public health organization in the world. It works with its member countries to improve the health and the quality of life of the people of the Americas. It serves as the Regional Office for the Americas of WHO and is part of the Inter-American system.