The National Agency for Food and Drug Administration and Control (NAFDAC) was established by Decree No. 15 of 1993 as amended by Decree No. 19 of 1999 and now the National Agency for Food and Drug Administration and Control Act Cap N1 Laws of the Federation of Nigeria (LFN) 2004 to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale and use of Food, Drugs, Cosmetics, Medical Devices, Packaged Water, Chemicals and Detergents (collectively known as regulated products). The agency was officially established in October 1992.
The National Health Research Ethics Committee (NHREC) is the apex body responsible for the provision of and ensuring adherence to guidelines that govern ethical research practice in order to ensure the protection of human research participants in Nigeria.
The Nigeria Association of Pharmacists in Academia (NAPA) is the umbrella body for all pharmacists working in tertiary educational institutions and research institutes across the country. The main aim of the Association is to serve as a support for development, capacity building and enhancement of members welfare using the instruments of communication, training and exposure to opportunities. NAPA is a technical group of the Pharmaceutical Society of Nigeria (PSN) solely responsible for training pharmacy students in various Pharmacy schools across the country.
The Nigerian Medical Association is the largest medical association in the West African sub-region with over 40,000 members. The NMA is involved in influencing health policy formulation, but it is only consulted by the federal government on an ad-hoc basis. The association aims to become more a part of the Ministry of Health, to ensure that it is as involved as possible in the planning stages of health policy formulation. NMA’s membership spans all six major specialties of Internal Medicine, Surgery, Obstetrics and Gynaecology, Paediatrics, Public Health, and Laboratory Medicine/Pathology. The major goal of the Nigerian Medical Association is to assist the government and the people of the Federal Republic of Nigeria in the provision of a smooth, efficient, and effective healthcare delivery system in the country. To promote the welfare, and interaction of all medical and dental practitioners in the country.
NIPRID became functional in the year 1989. In 2001, the International Organization for Standardization accreditation (ISO/IEC 17025) as well as the Standards Organisation of Nigeria (SON) certification (ISO 9001:2015). This enables the body’s laboratory to carry out quality control tests for medicines, food, cosmetics, herbal product, and agricultural products that will be accepted globally.
The Nigerian Institute of Medical Research (NIMR) is a reputable point of reference in basic, applied and operational research for the promotion of national health and development in Nigeria. NIMR play a vital role in developing viable structures for the dissemination of research findings, and providing the enabling environment and facilities for health research and training in cooperation with the Federal and State ministries of health and in collaboration with universities, allied institutions and organized private sector nationally and internationally.
PHARMACY BOARD OF SIERRA LEONE
The Pharmacy Board of Sierra Leone was established through an Act of Parliament in 1988 and reviewed in 2001 to regulate Pharmaceutical Products Medical Devices Cosmetic Chemical substances food and dietary supplement and herbal products the practice of Pharmacy and any other matters related thereof. The Board therefore regulates the following:
- Manufacturing establishments and Pharmaceutical premises
- Pharmacy professionals
- Pharmaceutical Products and other related substances
- Advertisement of all of the above mentioned products
The Pharmacy Board of Sierra Leone aims at implementing appropriate and workable regulatory of the practice of pharmacy by professionals and of safety efficacy and quality of all drugs medical devices cosmetics and nutritional agents (collectively termed “products”) locally manufactured imported exported distributed sold or used to ensure the protection of the public health as envisaged by the Pharmacy and Drugs Act 2001
NATIONAL DRUG AUTHORITY, UGANDA
The National Drug Authority (NDA) was established in 1993 by the National Drug Policy and Authority Statute which in 2000 became the National Drug Policy and Authority (NDP/A) Act, Cap. 206 of the Laws of Uganda (2000 Edition).
The Act established a National Drug Policy and National Drug Authority to ensure the availability, at all times, of essential, efficacious and cost-effective drugs to the entire population of Uganda as a means of providing satisfactory healthcare and safeguarding the appropriate use of drugs.
The functions of the Drug Authority are stated under Section 5 of the NDP/A Act, Cap. 206.
- Deal with the development and regulation of the pharmacies and drugs in the country
- Control the importation, exportation and sale of pharmaceuticals
- Control the quality of drugs
- Promote and control local production of essential drugs
- Encourage research and development of herbal medicines
- Establish and revise professional guidelines and disseminate information to the health professionals and the public
- Provide advice and guidance to the Minister and bodies concerned with drugs on the implementation of the National Drug Policy
- Perform any other function that is connected with the above or that may be accorded to it by law.
PHARMACY AND POISON BOARD (PPB) KENYA
The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya.
The Board regulates the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons
The Board aims to implement the appropriate regulatory measures to achieve the highest standards of safety, efficacy and quality for all drugs, chemical substances and medical devices, locally manufactured, imported, exported, distributed, sold, or used, to ensure the protection of the consumer as envisaged by the laws regulating drugs in force in Kenya.
AFRICAN VACCINE REGULATORY FORUM (AVAREF)
The African Vaccine Regulatory Forum (AVAREF) is a network of African national regulatory authorities and ethics committees that uses harmonization and reliance as pillars for capacity building. AVAREF works to ensure collaboration between key stakeholders across the continent—including donors, health professionals, and regional economic blocs—by promoting joint reviews and the sharing of work and expertise.
As a result of AVAREF’s efforts, vaccines against meningitis, malaria, rotavirus, pneumococcal pneumonia, and Ebola have been developed, and medicines against neglected diseases such as human African trypanosomiasis and leishmaniasis are currently being developed.
AVAREF’s mission is to help national regulatory authorities, ethics committees, and sponsors achieve consensus on ethical and regulatory questions surrounding the research and development of medical products in Africa. Its primary aim is to improve access to medical products across the continent by reducing review and approval times for clinical trial applications, while also optimizing quality of regulatory processes.
Since AVAREF was formed in 2006, it has evolved into a strong network of partners and medical professionals who work together with Member States to build capacity and improve the harmonization of regulatory practices on the African continent in support of product development.
THE ZAMBIA MEDICINES REGULATORY AUTHORITY
The Zambia Medicines Regulatory Authority formally the Pharmaceutical Regulatory Authority is the Statutory National Medicines Regulatory Body for Zambia established under an Act of Parliament, the Medicines and Allied Substances Act No. 3 of 2013 of the Laws of Zambia to regulate and control the manufacture, importation, storage distribution, supply, sale and use of medicines and allied substances. The main objective of the Authority is to ensure that all medicines and allied substances being made available to the Zambian people consistently meet the set standards of quality, safety and efficacy
FOOD AND DRUG AUTHORITY, GHANA
The FDA established in 1992 and integrated into a new public health act in 2012 has as its vision to protect the health and safety of people in Ghana and be a global centre of excellence for food and medical product regulation through the enforcement of relevant standards.