Therapeutic Products Directorate
- Therapeutic Products Directorate
Therapeutic Products Directorate (TPD) is a Canadian federal authority that regulates pharmaceutical drugs and medical devices for human use, a role performed by the Food and Drug Administration in the United States. Prior to being given market authorization, a manufacturer must present substantive scientific evidence of a product's safety, efficacy, and quality as required by the Food and Drugs Act and Regulations.
ee also
*European Medicines Agency
*Good Manufacturing Practice
*Good clinical practice
*Informed consent
*Institutional review board
*International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
*Investigational product
*Investigator's Brochure
Wikimedia Foundation.
2010.
Look at other dictionaries:
Health Products and Food Branch — The Health Products and Food Branch (HPFB) of Health Canada manages the health related risks and benefits of health products and food by minimizing risk factors while maximizing the safety provided by the regulatory system. HPFB has seven… … Wikipedia
Regulation of therapeutic goods — The regulation of therapeutic goods, that is 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… … Wikipedia
Medicines and Healthcare products Regulatory Agency — The logo of the MHRA. The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work and are acceptably safe. The agency was formed on 1 April… … Wikipedia
List of clinical research topics — Clinical research is the aspect of biomedical research that addresses the assessment of new pharmaceutical and biological drugs, medical devices and vaccines in humans. Contents 1 General topics 2 Drug terminology 3 T … Wikipedia
Drug Identification Number — Any product defined as a drug under the Canadian Food and Drugs Act must have an associated Drug Identification Number (or DIN). The Drug Identification Number (DIN) is the 8 digit number located on the label of prescription and over the counter… … Wikipedia
Regulation and prevalence of homeopathy — Homeopathy is fairly common in some countries while being uncommon in others; is highly regulated in some countries and mostly unregulated in others. Regulations vary in Europe depending on the country. In some countries, there are no specific… … Wikipedia
Federal administration of Switzerland — Switzerland This article is part of the series: Politics and government of Switzerland … Wikipedia
Alexander Catsch — (Katsch) (1913 ndash; 1976 in Karlsruhe) was a German Russian medical doctor and radiation biologist. Up to the end of World War II, he worked in Nikolaj Vladimirovich Timefeev Resovskij’s Abteilung für Experimentelle Genetik at the Kaiser… … Wikipedia
EudraLex — is the collection of rules and regulations governing medicinal products in the European Union.VolumesEudraLex consists of 10 volumes: *Concerning Medicinal Products for Human use: **Volume 1 Pharmaceutical Legislation. **Volume 2 Notice to… … Wikipedia
Homeopathy — Homeopathy: coined in German from Greek hómoios ὅμοιος like + páthos πάθος suffering Oxford English Dictionary … Wikipedia