The United States Food and Drug Administration is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products.
Health Canada is the department of the Government of Canada responsible for national health policy. The department itself is also responsible for numerous federal health-related agencies, including the Canadian Food Inspection Agency (CFIA) and the Public Health Agency of Canada (PHAC), among others. These organizations help to ensure compliance with federal law in a variety of healthcare, agricultural, and pharmaceutical activities. This responsibility also involves extensive collaboration with various other federal- and provincial-level organizations in order to ensure the safety of food, health, and pharmaceutical products—including the regulation of health research and pharmaceutical manufacturing/testing facilities.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
The United States Federal Food, Drug, and Cosmetic Act is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, medical devices, and cosmetics. The FDA's principal representative with members of congress during its drafting was Charles W. Crawford. A principal author of this law was Royal S. Copeland, a three-term U.S. senator from New York. In 1968, the Electronic Product Radiation Control provisions were added to the FD&C. Also in that year the FDA formed the Drug Efficacy Study Implementation (DESI) to incorporate into FD&C regulations the recommendations from a National Academy of Sciences investigation of effectiveness of previously marketed drugs. The act has been amended many times, most recently to add requirements about bioterrorism preparations.
The National Medical Products Administration is a national bureau responsible for drug supervision under the State Council of China and is managed by the State Administration for Market Regulation.
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP).
An online pharmacy, internet pharmacy, or mail-order pharmacy is a pharmacy that operates over the Internet and sends orders to customers through mail, shipping companies, or online pharmacy web portal.
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical, pharmaceutical, and scientific expertise to protect and advance public health and safety.
Dora Nkem Akunyili was the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) of Nigeria from 2001 to 2008.
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is a Directorate of the Council of Europe that traces its origins and statutes to the Convention on the Elaboration of a European Pharmacopoeia.
mPedigree refers both to a mobile telephony shortcode platform that interconnects GSM mobile networks in a number of African and Asian countries to a central registry wherein pedigree information of product brands belonging to participant manufacturers are stored, as well as the organisation that was founded in 2007 to manage and promote this registry to organisations and governments in Africa and other parts of the world. The latter is named the mPedigree Network. In December 2015, the mPedigree Network rebranded to 'mPedigree', and begun to trade under that name and a new logo, based on a knight-of-chess motif.
The following outline is provided as an overview of and topical guide to clinical research:
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical item which is produced and sold with the intent to deceptively represent its origin, authenticity, or effectiveness. A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body, may contain ingredients that are not on the label, or may be supplied with inaccurate or fake packaging and labeling. Counterfeit drugs are related to pharma fraud. Drug manufacturers and distributors are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs. Antibiotics with insufficient quantities of an active ingredient add to the problem of antibiotic resistance.
The Federal Ministry of Health is one of the Federal Ministries of Nigeria concerned with the formulation and implementation of policies related to health. It is headed by two Ministers appointed by the President, assisted by a Permanent Secretary, who is a career civil servant. The current Minister of Health is Muhammad Ali Pate. The current Minister of State for Health is Tunji Alausa. The Federal Ministry Of Health has over 800 workers consisting of closely 430 women and 370 men.[5]
The Central Drugs Standard Control Organisation (CDSCO) is India's national regulatory body for cosmetics, pharmaceuticals and medical devices. It serves a similar function to the European Medicines Agency of the European Union, the PMDA of Japan, the Food and Drug Administration (FDA) of the United States, and the Medicines and Healthcare products Regulatory Agency of the United Kingdom, and the State Administration for Market Regulation of China. The Indian government has announced its plan to bring all medical devices, including implants and contraceptives under a review of the Central Drugs and Standard Control Organisation (CDSCO).
EMDEX is the most commonly used reference source of drug and therapeutic information by healthcare professionals in Nigeria. It was first published in 1991 as Nigeria's Essential Drugs (NED) Guide.
EMDEX drug information contents, arrangements, and therapeutic recommendations are supported by several references and clinical guidelines notably WHO Model Formulary, WHO ATC Classification System, Nigeria's Essential Medicines List, and Standard Treatment Guidelines, etc. The information is regularly reviewed and updated by a select team of healthcare practitioners and academics.
The central objective of EMDEX has been to promote the rational use of medicines through the provision of independent drug information, and the use of clinical guidelines and essential medicines list. It is the largest and most up-to-date source of information on drug products approved for use in Nigeria by NAFDAC .
The use of EMDEX as a reference drug manual is endorsed by the Pharmacists Council of Nigeria, the Nursing & Midwifery Council of Nigeria, and major health institutions. It is used both within and outside Nigeria by physicians, dentists, pharmacists, nurse practitioners, and auxiliary health workers at all levels of healthcare delivery. These healthcare providers rely on EMDEX for accuracy and completeness of drug information namely indications, contra-indications, precautions or warnings, adverse effects, dosages, and drug use in special populations like children, elderly, pregnancy & lactation.
EMDEX publications are also in the syllabus of various colleges & schools of medicine, pharmacy & nursing.
Mojisola Christianah Adeyeye is a Nigerian pharmacist and professor. She was appointed the Director-General of National Agency for Food and Drug Administration and Control (NAFDAC) on 3 November 2017 by the President of The Federal Republic of Nigeria, Muhammadu Buhari. Before her appointment as NAFDAC boss, she was the founding Chair of Biopharmaceutical Sciences and a Professor of Pharmaceutics, Manufacturing Science and Drug Product Evaluation at the College of Pharmacy, Roosevelt University in Schaumburg, Illinois, where she spent 7 years. She was also a Professor of Pharmaceutics and Manufacturing for 21 years at Duquesne University in Pittsburgh, Pennsylvania, USA. She is Senior Fulbright Scholar and Specialist and 2008 American Association of Pharmaceutical Scientists Fellow. She is also a Fellow of the Nigerian Academy of Science and Nigeria Academy of Pharmacy. Her research interests are in the areas of pre-formulation, early phase development of solid, semisolid and liquid dosage forms, and IND-based and intellectual property-driven late phase drug product development. She is the founder and President of Elim Pediatric Pharmaceuticals Rolling Meadows, Illinois. Through Duquesne University, she was able to develop an anti-retroviral (HIV/AIDS) pediatric fixed-dose combination and received intellectual property on the formulations in the UK and South Africa.
The National Institute for Pharmaceutical Research and Development (NIPRD) is a Nigerian institution charged with developing drugs, biological products, and pharmaceutical raw materials, conducting quality-assurance tests, research for locally manufactured medicines and constituting guidelines for their production. Founded in 1987, it was a parastatal under the Federal Ministry of Science and Technology. In 2001, it was moved to Federal Ministry of Health.
Charles Obadiah Nimma Wambebe was a professor of pharmacology from Nigeria and served as the director-general/chief executive officer of the National Institute for Pharmaceutical Research and Development (NIPRD), Abuja. He contributed to the development of Niprisan, a phytomedicine for sickle cell disorder management, which led to The World Academy of Sciences Award in Medical Sciences. He also worked as a consultant in traditional medicine for various international organisations and held professorships at Tshwane University of Technology and Makerere University.
