Medicines Control Agency MCA

Medicines Control Agency (MCA) Medical Matrix Medical Research Council MEDLINE (free)... 

Repeat-dose toxicity studies should be performed in a rodent, typically the rat, and a non-rodent. The longer the duration of human exposure, the longer must be the duration of the toxicity studies. The ICH guideline indicates that for Phase I and Phase II studies, the clinical duration can equal the duration of the toxicity studies in all regions. This concords with the UK guidelines revised by the Medicines Control Agency (MCA) in December 1995. ... 

Over the period, the successive professional heads of the Medicines Division have been Dr DA Cahal (1964-70), Dr D Mansel-Jones (1970-4), Dr EL Harris (1974-7), Dr JP Griffin (1977-84) and Dr G Jones (1984-9). In 1989, when the Medicines Division was reorganised into the Medicines Control Agency (MCA) (see section 16.7), Dr KH Jones was appointed the first Director of the new Agency. 

The applications for national authorisations are submitted to the national competent authority which, in the United Kingdom, is the Licensing Authority (LA), whose functions are discharged by the Medicines and Healthcare products Regulatory Agency (MHRA, previously Medicines Control Agency, MCA) of the Department of Health. The LA/MHRA are advised by the CSM, a multidisciplinary scientific body consisting of clinical, preclinical and pharmaceutical members well known for their expertise in their respective fields. Lay members are also included. 

Medicines Control Agency (MCA). Rules and Guidance for Pharmaceutical Manufacturers and Distributors 1997, Part Four—Good Manufacturing Practice for Medicinal Products. The Stationary Office, London. 

The release of a new drug onto the market must be approved by the regulating authority for that country. For example, in Britain this is the Medicines Control Agency (MCA), in the European Union it is the European Medicines Evaluation Agency (EMEA) and in the USA the US Food and Drugs Administration (FDA). These bodies, which are essentially consumer protection agencies, issue a so called product licence or marketing authority (MA) when they are satisfied... 

Such as the European Medicines Evaluation Agency (EMEA), or the British Medicines Control Agency (MCA) and Committee on Safety of Medicines (CSM), or Italy s Pharmaceutical Commission. Throughout the book, general references to the FDA imply or other international regulatory body. ... 

The Licensing Authority consists of the responsible Minister(s) and the Medicines Control Agency (MCA) — the executive arm in the Department of Health. 

Regulatory bodies around the world have given approval for NIR methods for a variety of purposes. In June 1995, the Medicines Control Agency (MCA) granted approval to Glaxo Wellcome in the United Kingdom for a NIR method for the identification and assay of Zovirax (acyclovir) tablets. This is believed to be the first official approval for NIR granted by the MCA as an assay method for tablets. 

Without going into more detail it should be pointed out that the NIP mirrors, both in its organization and responsibilities, its counterpart in the European medicines control agencies (the Medicines Control Agency [MCA] in the United Kingdom, the Medical Product Agency [MPA] in Sweden, the medicines part of the National Board of Health in Denmark, etc.). 

Committee on Safety of Medicines (CSM) An independent body set up to give advice via the Medicines Control Agency (MCA), which administers the Medicines Act, to the licensing authorities under the Ministry of Health, competitive anatgonism See antagonism -pharmacodynamic. 

In 1988, the DHSS was split into two departments, the Department of Health (DoH) and the Department of Social Security (DSS). Following the Evans-Cunliffe report, from April 1989, the Medicines Division of the DoH became the Medicines Control Agency (MCA) under a director, and was expected to self-fund its operation from fees commensurate with the services provided. The UK MCA in 1997 had 458 staff, of whom 150 approximately worked in licensing, 130 in post-licensing, including pharmacovigilance, 75 in licensing inspection of manufacture and enforcement, and... 

Medicines Control Agency (MCA) National Institutes of Health National Library of Medicine Regulatory Affairs Professional... 

The UK fees to the Medicines Control Agency (MCA) for a major application over the past seven years have varied from about 60,000 to 100,000, the costings being very carefully calculated and adjusted if necessary year on year. The fee for an NCE is 74,657 for the year beginning 1 April 2002. The allocation of 57,500 (equivalent to 35,900) to a UK rapporteur or co-rapporteur would therefore appear to leave a significant shortfall. 

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