centralize & decentralize regulatory framework of brazil and south africa

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Centralize & Decentralize Regulatory Framework of Brazil and South Africa BY- Harishankar Sahu

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Page 1: Centralize & decentralize regulatory framework of brazil and south africa

Centralize & Decentralize Regulatory Framework of Brazil and South Africa

BY-Harishankar Sahu

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Brazil's pharmaceutical market is the 11th largest in the world and second in Latin America after Mexico since the devaluation of 2001

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ANVISANational Health Surveillance Agency

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Introduction

• ANVISA is regulatory body of BRAZIL. Some of the small countries nearby Brazil are following the rules according to ANVISA.

• ANVISA means “Agencia Nacional de Vigilancia Sanitaria”. This abbreviation is in Portuguese language. In English, it means “National Health Surveillance Agency” or sometimes it is written as “Brazilian Health Surveillance Agency”.

• ANVISA is established on 26th January, 1999. Thus it does not have long historical backgrounds.

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– monitoring drug prices – prices of medical devices– control and inspection of smoking products– technical support in granting of patents by the National Institute

of Industrial Property.– protection of the health of the population by exercising sanitary

control over production– marketing of products and services subject to sanitary

surveillance, controlling ports, airports and borders – linked to the Brazilian Ministry of Foreign Affairs and foreign

institutions over matters concerning international aspects of sanitary surveillance.

• ANVISA is responsible for

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Regulations by ANVISA• Blood and blood products• Cosmetics• Drugs• Generic Drugs• Food • Health services• International Affairs• Market regulations• Medical devices• Pharmacovigilance• Ports, airports and borders• REBLAS – Brazilian network of Analytical Laboratory• Sanitizing Products • Tobacco• Toxicology

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OFFICES OF ANVISAADVISORY COUNCIL

It monitors and follows up the development of activities carried out by ANVISA.The main function of advisory council is to provide information upon request by any citizen, patient, industrialist or health professional on any topics. It has a general functioning common Advisory council.

OFFICE OF OMBUDSMAN

It is an independent body for direct communication of Citizens or Institutes to attend the Complaints. It is characterized by impartiality and transparency. It has no direct or indirect linking with ANVISA. It is regulated directly under the Brazilian ministry of health.

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REGULATORY FRAMEWORK IN SOUTH AFRICA

African medicines regulatory authorities (MRAs) role is to ensure that the pharmaceutical products those are needed, are registered in their country: This process is called “registration,” “marketing approval,” “marketing authorization” or “product licensing”, and involves assessment of product information submitted by the manufacturer (the product ‘dossier’) to make sure that it is safe and effective for use by local patients.Every country of the African region has its own regulatory framework. Drug product registration was gradually introduced in Tanzania under the Tanzania Food, Drugs and Cosmetics Act 2003, to have a smooth transition, beginning with 1-year provisional registration taken as a notification from 1998.

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All documents shall be in Kiswahili or English. Applications that do not comply to requirements prescribed in these guidelines will be rejected and returned to the applicant at his own cost. All ingredients used in the formulation of generic medicinal products must comply with specifications prescribed either in the USP (United States pharmacopoeia), BP (British pharmacopoeia), EP (European pharmacopoeia), and International or Japanese pharmacopoeia.In-house specifications shall only be accepted if the limits are tighter than those prescribed in those pharmacopoeias and other specifications may be accepted if they are validated.

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For many years, African medicines regulatory authorities (MRAs) have managed a broad range of responsibilities, often with limited resources . Their focus has generally been on providing their population with access to a wide range of affordable essential medicines, usually generics, with less emphasis on rapid access to the latest products. As a result, African national MRAs may have experience in managing generics, but many have only limited experience in assessing, approving and registering innovator products, the vast majority of which are for global chronic diseases, such as diabetes, hypertension and cancer.

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REGISTRATION OF MEDICINESThe registration of medicine in South Africa is governed by the provisions and requirements of the Medicines and Related Substances Control Act No.101 of 1955.

The Medical Control Council endeavors to regularly update the guidelines to reflect current technical requirements and evaluation policies.

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AFRICAN MEDICINE HARMONISATION INITIATIVEThe African Medicines Registration Harmonisation (AMRH) Initiative is a welcome move. Investing in the AMRH initiative also provides an opportunity for African countries to strengthen their regulatory capacity, use their financial and human resources more effectively, thereby creating a more conducive environment for the attainment of the health-related Millennium Development Goals (MDGs)

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CONCLUSIONPharmaceutical companies operating in African markets are experiencing difficulties in complying with the technical requirements of individual African countries.

The African Regulatory Framework is scattered according to country by country and strict guidelines are not enforced whereas in Brazil the regulatory framework is more centralized and systemic.

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REFERENCE

•http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3471191/•www.anvisa.com