ANVISA is Brazil's centralized regulatory body that oversees pharmaceuticals and health products. It regulates drugs, medical devices, cosmetics and other products. In contrast, regulatory frameworks in African countries are more decentralized and vary between countries. The African Medicines Registration Harmonisation initiative aims to strengthen regulatory capacity and harmonize requirements across African nations to facilitate regional access to medicines.

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

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

3. ANVISA
National Health Surveillance Agency

4. 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.

5. – 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

6. 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

8. OFFICES OF ANVISA
ADVISORY 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.

9. 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.

10. 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.

11. 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.

12. The 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.

13. The 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)

14. Pharmaceutical 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.

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