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Marketing Authorisation Application (MAA) is an application submitted by a drug manufacturer seeking marketing authorisation, that is permission to bring a medicinal product (for example, a new medicine or generic medicine) to the market.
The Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was rebranded as the Clinical Practice Research Datalink (CPRD). In April 2013, MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used for ...
The California Code of Regulations (CCR, Cal. Code Regs. ) is the codification of the general and permanent rules and regulations (sometimes called administrative law ) announced in the California Regulatory Notice Register by California state agencies under authority from primary legislation in the California Codes .
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 ...
A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing ...
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 Food and Drug Administration (FDA) of the United States or the European Medicines Agency of the European Union.
The Pharmacopoeia 2018 was released by Secretary, Ministry of Health & Family Welfare, Government of India. [ 5 ] I.P. , the abbreviation of 'Indian Pharmacopoeia' is familiar to the consumers in the Indian sub-continent as a mandatory drug name suffix.
Download QR code; Print/export Download as PDF; Printable version; In other projects Wikidata item; Appearance. move to sidebar hide ... MHRA may refer to: Organisations