MHRA Medicines and Healthcare products Regulatory

MHRA Medicines and Healthcare Products Regulatory Agency... 

MHRA Medicine and Healthcare products Regulatory Authority... 

MHRA - Medicines and healthcare products Regulatory Agency (formerly MCA - Medicines Control Agency). A UK based regulatory body responsible for the Medicines Act. It has catagories for medicines and foods and is looking at herbal products (in the Traditional Herbal Products Directive introduced in 2005) and other materials used in complementary health. 

MHRA (Medicines and Healthcare Products Regulatory Agency) (2008) Drug Safety Update, Volume 1, Issue 6, January. Available at http //www.mhra.gov.uk/Public ations/ Safetyguidance/DrugSafetyUpdate/CON2033505 [Accessed 10 April 2008],... 

MHRA Medicines and Healthcare Products Regulatory Agency, United Kingdom MHW Ministry of Health and Welfare, Japan MOA Mode of action... 

MHRA. Medicines and Healthcare products Regulatory Agency. The executive body charged with drug regulation in the United Kingdom... 

MHRA—Medicines and Healthcare products Regulatory Agency (UK)... 

In the United Kingdom, clinical trial applications are submitted to the Medicines and Healthcare Products Regulatory Agency (MHRA). There are several schemes for clinical trial application the major two are the Clinical Trial Certificate (CTC) and Clinical Trial Exemption (CTX) schemes. 

The minimum standards for the facilities in which clinical pharmacology studies should be conducted are described in ABPl guidelines. Clearly, the same standards should apply to all organisations involved in conducting studies. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) has instituted inspection of facilities and procedures, and a system of certification is in place. 

In this, the fifth edition of this textbook, the title of the present chapter has been changed to The Safety of Medical Products in order to include devices which are now included in the remit of the Medicines and Healthcare Products Regulatory Agency (MHRA). It has also been decided to revise the chapter so as to reflect more closely the current needs of the pharmaceutical physician whose experience may have been entirely in the field of clinical medicine. 

On the 12 September 2002, the Health Minister, Lord Philip Hunt announced that the MCA and the Medical Devices Agency (MDA) would merge with effect from 1 April 2003. The merged agency would be known as the Medicines and Healthcare products Regulatory Agency (MHRA). 

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. 

Each Member State has designated a competent authority, which is the governmental authority responsible for implementing the Directive in that Member State. In the case of the United Kingdom, the competent authority is the Medicines and Healthcare Products Regulatory Agency (MHRA). The principal function of a competent authority in practice is to ensure the safety and health of patients and users of MDs. 

Erythromycin may cause increases in the semm levels of simvastatin. The CSM has advised that this should not be co-prescribed with simvastatin. In the first instance the pharmacist should check local policies for management of hospital acquired chest infections/pneumonia to ascertain first and second line choices. If erythromycin or any macrolide cannot be avoided then a practical way forward may be to avoid taking any dose of simvastatin for the duration of the course of macrolide. In addition a recent Dmg Safety Update from the Medicines and Healthcare Products Regulatory Agency (MHRA, 2008) on statins has highlighted statin dmg interactions and the appropriate actions to take. 

Medicines and Healthcare products Regulatory Agency, 2005. MHRA Latest data on HRT from the UK Million Women Study. Available at http //www.mhra.gov.uk/home/ groups/comms-po/documents/news/con002085.pdf [Accessed 08 October 2008],... 

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) data show that several deaths have occurred from hepatotoxicity. Most reports of hepatic adverse drug reactions (ADRs) relate to atorvastatin and simvastatin [36]. There are relatively fewer for pravastatin and fluvastatin. However, this may reflect their ... 

European medical device requirements are defined in EU Directive 93/42/EEC published in 1994. National legislation and regulatory authorities such as the U.K. Medicines and Healthcare products Regulatory Authority (MHRA) enforce this directive. Four classes of device are defined, each of which requires a visible CE marking of conformity. CE marking of conformity means that the manufacturer is satisfied that the medical device conforms to relevant EU Directives and that it is fit for purpose. Technical documentation supporting conformity related to automated devices includes ... 

This chapter discusses what to expect during inspections, how inspectors approach their work, and how to manage the process of receiving an inspection. Specifically, inspections by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration (EDA) are explored. Preinspection questionnaires and inspection checklists used by the regulatory authorities are attached as appendices to this chapter. 

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