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 regulation of therapeutic goods, defined as drugs and therapeutic devices, varies by jurisdiction. In some countries, such as the United States, they are regulated at the national level by a single agency. In other jurisdictions they are regulated at the state level, or at both state and national levels by various bodies, as in Australia.
Ranitidine, sold under the brand name Zantac among others, is a medication used to decrease stomach acid production. It is commonly used in treatment of peptic ulcer disease, gastroesophageal reflux disease, and Zollinger–Ellison syndrome. It can be given by mouth, injection into a muscle, or injection into a vein. In September 2019, the probable carcinogen N-nitrosodimethylamine (NDMA) was discovered in ranitidine products from a number of manufacturers, resulting in recalls.
The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
Theralizumab is an immunomodulatory drug developed by Thomas Hünig of the University of Würzburg. It was withdrawn from development after inducing severe inflammatory reactions as well as chronic organ failure in the first-in-human study by Parexel in London in March 2006. The developing company, TeGenero Immuno Therapeutics, went bankrupt later that year. The commercial rights were then acquired by a Russian startup, TheraMAB. The drug was renamed TAB08. Phase I and II clinical trials have been completed for arthritis and clinical trials have been initiated for cancer.
The Health Protection Agency (HPA) was a non-departmental public body in the United Kingdom. It was set up by the UK government in 2003 to protect the public from threats to their health from infectious diseases and environmental hazards.
The Yellow Card Scheme is the United Kingdom's system for collecting information on suspected adverse drug reactions (ADRs) to medicines. The scheme allows the safety of the medicines and vaccines that are on the market to be monitored.
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.
The Clinical Practice Research Datalink (CPRD) is an observational and interventional research service that operates as part of the UK Department of Health. It is jointly funded by the National Institute for Health and Care Research(NIHR) and the Medicines and Healthcare products Regulatory Agency (MHRA). CPRD is working closely with the extensive primary care, topic specific and comprehensive NIHR research networks and with NHS Digital.
The Cambridge Biomedical Campus is the largest centre of medical research and health science in Europe. The site is located at the southern end of Hills Road in Cambridge, England.
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.
Sir Gordon William Duff, is a British medical scientist and academic. He was Principal of St Hilda's College, Oxford, from 2014 to 2021. He was Lord Florey Professor of Molecular Medicine at the University of Sheffield from 1991 to 2014.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Ian Robert Burton Hudson is a British physician and former government official who served as the chief executive of the Medicines and Healthcare products Regulatory Agency (MHRA) from 2013 to 2019. He later became Senior Advisor, Integrated Development, Global Health for the Bill and Melinda Gates Foundation. He was appointed an OBE for services to healthcare in the 2020 New Year Honours.
Molnupiravir, sold under the brand name Lagevrio, is an antiviral medication that inhibits the replication of certain RNA viruses. It is used to treat COVID‑19 in those infected by SARS-CoV-2. It is taken by mouth.
The Human Medicines (Amendment) Regulations 2020 is a statutory instrument (SI) that was laid before Parliament on 16 October 2020 to make provision for the strengthening of existing regulations that allow for the temporary authorisation of the supply of unlicensed medicines, including vaccines, in response to certain public health threats, and for the expansion of the workforce able to administer the COVID-19 vaccines and influenza vaccines. Certain amendments within the instrument, regulations 3, 12 and 3, allowing for the administration of vaccines by a wider range of medically trained people such as an "occupational health vaccinator" are time-limited to 1 April 2022.
Valneva COVID-19 vaccine is a COVID-19 vaccine developed by French biotechnology company Valneva SE in collaboration with the American biopharmaceutical company Dynavax Technologies.
Post-vaccination embolic and thrombotic events, termed vaccine-induced immune thrombotic thrombocytopenia (VITT), vaccine-induced prothrombotic immune thrombocytopenia (VIPIT), thrombosis with thrombocytopenia syndrome (TTS), vaccine-induced immune thrombocytopenia and thrombosis (VITT), or vaccine-associated thrombotic thrombocytopenia (VATT), are rare types of blood clotting syndromes that were initially observed in a number of people who had previously received the Oxford–AstraZeneca COVID‑19 vaccine (AZD1222) during the COVID‑19 pandemic. It was subsequently also described in the Janssen COVID‑19 vaccine, leading to the suspension of its use until its safety had been reassessed. On 5 May 2022 the FDA posted a bulletin limiting the use of the Janssen Vaccine to very specific cases due to further reassessment of the risks of TTS, although the FDA also stated in the same bulletin that the benefits of the vaccine outweigh the risks.
Sotrovimab, sold under the brand name Xevudy, is a human neutralizing monoclonal antibody with activity against severe acute respiratory syndrome coronavirus 2, known as SARS-CoV-2. It was developed by GlaxoSmithKline and Vir Biotechnology, Inc. Sotrovimab is designed to attach to the spike protein of SARS-CoV-2.
