Medicines Control Agency

Laboratories wishing to claim GLP compliance are nonually registered with Competent Authorities who issue statements of compliance following successful periodic inspections of the premises to monitor compliance with the relevant legislation. In the UK compliance with the Good Laboratory Practice Regulations 1999 is audited by the Medicines Control Agency. 

Tlie views expressed in this chapter are those of the author and do not necessarily represent the views or the opinions of the Medicines Control Agency, other regulatory authorities or any of dieir advisory committees. 

Sarah K. Branch Medicines Control Agency Market Towers 1 Nine Elms Lane London SW8 5NQ UK... 

Medicinal Products in 1989 and are now published in the UK as Rules and Guidance for Pharmaceutical Manufacturers and Distributors (1997) by the Medicines Control Agency, Department of Health. 

Zimbabwe has mles regarding the practice of traditional medicine, but not for registration of traditional medicinal products. In future, however, the Medicines control agency can be expected to exert some control over this category of product. In Cypms, there are no legislative provisions for herbal, dietary or homeopathic medicines, but some herbal medicines are registered as allopathic medicines. 

Regulation of medicines in Zimbabwe started in 1969, with the promulgation of the Dmgs and Allied Substances Control Act, Chapter 320. This Act created the Dmgs Control Council (a body corporate), which started operations in 1971. The 1997 amendment transformed the Dmgs and Allied Substances Control Act into the Medicines and Allied Substances Control Act (MASCA), Chapter 15 03, which established the Medicines Control Agency of Zimbabwe (MCAZ), with increased authority. 

The TGA in Australia, the MEB in the Netherlands and the Medicines Control Agency in Zimbabwe are financed entirely by the fees and charges they collect. Unlike the countries mentioned above, these dmg regulatory authorities have full powers to dispose of the revenue they collect. And because their financial viability depends on the revenue they generate, fees and charges reflect the real cost of services. 

Zimbabwe Medicines Control Agency administrative court... 

Malaysia Adverse Drug Reaction Advisory Committee Medicines Control Agency of Zimbabwe Medicines Evaluation Board (Netherlands)... 

These documents are available from relevant trade associations, some professional associations, such as BIRA and DIA, by subscription to schemes such as Euro Direct, operated by the UK Medicines Control Agency, and via the internet at http //www.eudra.org (or http //dg3.eudra.org for the item marked ). 

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

Medicines Control Agency. Rules and Guidance for Pharmaceutical Manufacturers and Distributors, MCA, 1997. 

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. ... 

Medicines Control Agency. Medicines Act 1968. Guidance Notes on Applications for Clinical Trial Exemptions Clinical Trial Certificates. Revised December 1995. London HMSO, 1995. 

Medicines Control Agency. Advertising and Promotion of Medicines in the UK (MHRA Guidance Note No. 23). London MHRA, 1999. 

Medicines Control Agency. Guidelines on the Summary of Product Characteristics (SPC) for Human Medicinal Products. Version 3, March 2001. London MHRA,2001. 

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. 

Promotional material must not include any reference to the Medicines Commission, the Committee on Safety of Medicines, the Medicines and Healthcare products Regulatory Agency, the Medicines Control Agency or the licensing authority, unless this is specifically required by the licensing authority. 

---