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The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The MHRA has several independent advisory committees which provide the UK Government with information and guidance on the regulation of medicines and medical devices. There are currently eight such committees: [citation needed] Advisory Board on the Registration of Homeopathic Products; Herbal Medicines Advisory Committee; The Review Panel
Critical process parameters (CPP) in pharmaceutical manufacturing are key variables affecting the production process. CPPs are attributes that are monitored to detect deviations in standardized production operations and product output quality or changes in critical quality attributes .
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.
MHRA may refer to: Organisations. Medicines and Healthcare products Regulatory Agency, UK; Michigan Hot Rod Association, US; Modern Humanities Research Association, UK
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 Human Medicines Regulations 2012 in the United Kingdom were created, under statutory authority of the European Communities Act 1972 and the Medicines Act 1968 in 2012. . The body responsible for their upkeep is the Medicines and Healthcare products Regulatory Age
WHO Good Clinical Laboratory Practice (GCLP) ISBN 978-92-4-159785-2 Stevens W. (2003) Good Clinical Laboratory Practice (GCLP): The need for a hybrid of Good Laboratory Practice and Good Clinical Practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries.