Brazilian Health Surveillance Agency - Anvisa & Brazilian Pharmacopoeia Global Regulatory Harmonization Opportunities
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1 Agência Nacional de Vigilância Sanitária Anvisa Brazilian Health Surveillance Agency - Anvisa & Brazilian Pharmacopoeia Global Regulatory Harmonization Opportunities Norberto Rech Brazilian Pharmacopoeia President São Paulo, August 2014
2 BRAZILIAN HEALTH SURVEILLANCE AGENCY (ANVISA) Agência Nacional de Vigilância Sanitária Anvisa National Health Surveillance System in SUS Federal Ministry of Health National Council of Health ANVISA FIOCRUZ INCQS Established by Federal Law 9.782/1999 (Health Surveillance Law 6.360/1976); Agency is linked to the Ministry of Health (Federal Public Administration). Municipal Level Local Secretary of Health Local Council of Health Local Health Surveillance State Level State Secretary of Health State State Level Council of Health State Secretary State Health of Surveillance Health State Council LACENS of Health State Health Surveillance LACENS Collegiate Board of 5 Directors; Coordinates the National Health Surveillance System (SNVS); Headquarters located in Brasilia DF; 83 local offices throughout Brazil at ports, airports and borders.
3 THINKING FORWARD National Agência Regulatory Nacional de Authority Vigilância & Pharmacopoeia Sanitária Anvisa CURRENT SITUATION PRINCIPLES FOR THE FUTURE Potential Health Risks posed by the complexity of the health product supply chain Multiplication of Efforts Harmonization / Standardization Improve the regulation and surveillance global capacity by recognizing, promoting and improving local capacities Identify synergies, reunite all efforts and build coalition mechanisms Achievement of Adequate Level of Protection
4 THINKING FORWARD National Agência Regulatory Nacional de Authority Vigilância & Pharmacopoeia Sanitária Anvisa Work closely to strategic partners for the implementation of international technical cooperation, promoting the exchange of experiences and knowledge. Identify synergies, reunite all efforts and build coalition mechanisms. Improve International Technical Cooperation between regulatory authorities and Phamacopoeias.
5 Strategic Objectives Agência Nacional OPPORTUNITIES de Vigilância Sanitária Anvisa Periodically define strategies and mechanisms for convergence and harmonization, and support their dissemination, adoption, and implementation by the regional NRAs and Pharmacopoeias NEW CHALLENGES = NEW PRIORITIES = NEW NETWORK
6 Strategic Objectives Agência Nacional OPPORTUNITIES de Vigilância Sanitária Anvisa - Cooperation to help countries to establish effective regulatory systems that apply international pharmaceutical regulatory standards progressively and systematically, and contribute to regional regulatory convergence. - Disseminate the standards that have already been developed and support countries in their adoption and implementation, and update standards that support the development of the NRAs and Phamacopoeias critical functions. - Increasing number of new health topics for regulation (such as high complexity technologies, including biotechnological and genomic products, medical and diagnostic devices).
7 Strategic Objectives - How to reach it? Agência Nacional de Vigilância Sanitária Anvisa Take advantage of existing experiences of cooperation between NRA, Pharmacopoeias and of the global harmonization work that is already in place (including the promotion of guidance from major harmonization bodies, Good Pharmacopoeial Practices). Establish communication tools to be used to disseminate the Network s priorities and technical standards. Enhance cooperative relationships with each pharmacopoeia including Japanese Pharmacopoeia, USP, EP and WHO. International information exchange among pharmacopoeias Workshop for training Exchange of experts
8 Strategic Objectives - How to reach it? Agência Nacional de Vigilância Sanitária Anvisa Establish formal cooperation with the Japanese Pharmacopoeia for: Exchange of information Development and sharing of monographs, including all drugs which are important for the National Health Systems. Development of chemical reference substances. Act to make possible the introduction of new knowledge and the latest science and technology. Following the building of the Mercosur Pharmacopoeia and Good Pharmacopoeial Practices.
9 Agência Nacional de Vigilância Sanitária Anvisa Thank you for your attention
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ISSUES AND PROBLEMS IN THE IMPLEMENTATION OF STANDARD INDUSTRIAL CLASSIFICATION -- THE BRAZILIAN CASE. by Magdalena Cronemberger Góes, IBGE, Brazil
ESA/STAT/AC.63/8 30 September 1998 UNITED NATIONS DEPARTMENT OF ECONOMIC AND SOCIAL AFFAIRS STATISTICS DIVISION Fourth Meeting of the Expert Group on International Economic and Social Classifications New