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International Pharmaceutical Excipients Council is a global organization founded in 1991 representing producers, suppliers, and end users of excipients. The body has three divisions in Europe , Japan , and the United States , each of which focuses on local regulations concerning the excipients market, as well as on new research and business ...
Pharmacopoeial reference standards are a subset of pharmaceutical reference standards. They are established for the intended use described in pharmacopeial texts (monographs and general chapters). Pharmacopeial reference standards are available from various pharmacopoeias such as United States Pharmacopeia and the European Pharmacopoeia. Where ...
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of the Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products. [1] [2] The initial members comprised the 10 member countries of EFTA at that time.
The Common Technical Document is divided into five modules: [4] Administrative and prescribing information; Overview and summary of modules 3 to 5; Quality (pharmaceutical documentation)
World Health Organization building from the South-East, Geneva The International Pharmacopoeia (Pharmacopoeia Internationalis, Ph. Int.) is a pharmacopoeia issued by the World Health Organization [1] as a recommendation, with the aim to provide international quality specifications for pharmaceutical substances (active ingredients and excipients) and dosage forms, [2] together with supporting ...
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
In the 1980s, the European Union began harmonising regulatory requirements. In 1989, Europe, Japan, and the United States began creating plans for harmonisation. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) was created in April 1990 at a meeting in Brussels.