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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 ...
The UCPMP is an extension of the Uniform Code for Pharmaceuticals Marketing Practices 2015 (UCPMP 2015), which took effect on 1 January 2015.Although there were long-standing expectations that the 2015 Code would be legally enforced, it remained a voluntary guideline for pharmaceutical companies to follow in their marketing practices.
The electronic common technical document (eCTD) is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information. The specification is based on the Common Technical Document (CTD) format and was developed by the International Council for Harmonisation (ICH) Multidisciplinary Group 2 ...
Cover of the European Pharmacopoeia, 11th Edition. The European Pharmacopoeia [1] (Pharmacopoeia Europaea, Ph. Eur.) is a major regional pharmacopoeia which provides common quality standards throughout the pharmaceutical industry in Europe to control the quality of medicines, and the substances used to manufacture them. [1]
The British Pharmacopoeia (BP) is the national pharmacopoeia of the United Kingdom.It is an annually published collection of quality standards for medicinal substances in the UK, which is used by individuals and organisations involved in pharmaceutical research, development, manufacture and testing.
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 ...
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 ...
The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, [1] is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately.