Proceedings of the Tenth International Conference of Drug Regulatory Authorities (ICDRA) - Hong Kong, China, 24 - 27 June 2002
(2002; 166 pages) View the PDF document
Table of Contents
View the documentAbbreviations and acronyms used in this report
Open this folder and view contentsOpening ceremony
Open this folder and view contentsHerbal medicines
Open this folder and view contentsKeynote address
Open this folder and view contentsSafety of blood-derived products
Open this folder and view contentsAntimicrobial resistance - new initiatives
Open this folder and view contentsHarmonization I
Close this folderHarmonization II
View the documentRegional harmonization initiatives - the Association of South-East Asian Nations (ASEAN)
View the documentHarmonization in the Americas
View the documentCentralized drug registration system in the Gulf Region
View the documentRecommendations
Open this folder and view contentsProtection of trial subjects in clinical trials
Open this folder and view contentsRegulating biotechnology products
Open this folder and view contentsRegulatory challenges: health sector reform and drug regulatory capacity
Open this folder and view contentsAccess to drugs and vaccines I
Open this folder and view contentsAccess to drugs and vaccines II
Open this folder and view contentsCounterfeit pharmaceutical products
Open this folder and view contentsHomoeopathy
Open this folder and view contentsSafety monitoring
Open this folder and view contentsE-Commerce
Open this folder and view contentsCurrent topics
Open this folder and view contentsRegulatory challenges of new technologies
View the documentList of participants
View the documentBack cover

Harmonization in the Americas

Dr Grandville G. de Oliveira, Brazil

The Brazilian Sanitary Surveillance Agency (now called ANVISA) is the national regulatory agency in Brazil. It has financial and administrative independence despite being politically subordinate to the Ministry of Health. There are five directors, appointed for three years, who are responsible for developing plans for the Government. ANVISA has responsibilities in various specific areas, including products (e.g. biologicals, drugs, devices and cosmetics), medical and health services, price monitoring and the borders. It also deals with international affairs and financial and administrative matters. The administration of the health system has three levels: (1) federal, (2) state and (3) municipal/county. The mission is to protect and to promote health, by ensuring the safety of products and services.

The vision of ANVISA is “To be the agent of transformation of the decentralized sanitary surveillance system within a network, holding a distinct position, legitimized by the population, as regulator and promoter of social welfare.” Acting at the national level, ANVISA has as main activities the decentralization of surveillance, interaction with society, and the development of relationships with the regulated sector. The concept of essential drugs was developed in 1971. ANVISA is also responsible for national regulation and international harmonization. Harmonization has been achieved through the Pan American Network for Drug Regulatory Harmonization (PANDRHA) and MERCOSUR, the Southern Common Market.

The participants in PANDRHA are the regulatory authorities from each member state and representatives from industry, academia, professional groups, consumers, regional economic integration groups, global drug harmonization initiatives, and other interested groups. The initiative to support the processes of regulatory harmonization covers the whole of the Americas, with the coordination of the Pan American Health Organization. It deals with issues related to bioequivalence, good manufacturing practices, good clinical practice, counterfeit drugs and the pharmacopoeia. New issues to be taken up include medicinal plants, pharmacovigilance, drug registration and drug classification. Three conferences have already taken place.

MERSOCUR comprises Argentina, Brazil, Paraguay and Uruguay, and is a political and economic grouping. MERCOSUR seeks to harmonize efforts in health, to improve health protection and to eliminate nontariff barriers to increased flow of goods at national, regional and international levels. Some results are:

• regulation is harmonized among members, and the national legislation of each member state must reflect the agreements and be enacted simultaneously;

• the technical skills of human resources are improved through control and inspection;

• joint inspection programmes are carried out on manufacturing companies;

• sanitary surveillance systems have been improved in all member states;

• there is a common drug policy.


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