MHRA

Investigations into Adverse Incidents During Clinical Trials of TGN1412 [online]. Available at http //www.mhra.gov.uk/home/groups/comms-po/documents/websiteresources/... 

Source Medicines and Healthcare Products Regulatory Agency. Clinical Final Report on rGM4i2.http //www.mhra.gov.uk/home/idcplg IdcService=SS GET PAGE useSecondary= true ssDocName=CON2023822 ssTargetNodeId=389 [accessed September 18,2007]. 

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 Sponsor must inform the MHRA of any refusal by an ethics committee to permit the trial. 

MHRA Medicines and Healthcare Products Regulatory Agency... 

Guide to the UK GLP Regulations 1999. Department of Health, The United Kingdom Good Laboratory Practice Monitoring Authority, 2000 London MHRA Publications. 

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. 

Medicines and Heaithcare products Reguiatory Agency (MHRA)... 

Further modifications to advertising. Articles 86-100 of the EU Pharmaceutical Legislation Review 2001, now consolidated, do not even mention the internet. Should the proposals be accepted, the term advertising of medicinal products will in future include the phrase awareness of the availability of such products. This will, by implication, include the internet. The MHRA has published advice on advertising... 

This is the name of what we used to know simply as the data sheet, or colloquially as the package insert. The SPC is the document that must be submitted in draft by companies to the MHRA/Reference Member State/European Medicines Evaluation Agency upon application for a marketing authorisation and, once approved, must then be provided to prescribers or suppliers of medicines, either with the product or at the time of promotion or within the previous 15 months of promotion of the product, written or verbal. The SPC includes the prescribing information for the product and represents the product licence approval for the medicine (see Section 12.2.1.1). It is the definitive statement between the competent authority and the company and, more importantly, is becoming the common basis of communication between the... 

The MHRA has already addressed the relationship between the SPC and the data sheet and how the latter is superseded by the former. Additional guidance has been released recently regarding the content and format and the presentation of undesirable effects and has been adopted for updated or new SPC in future in the European Union. This is aimed at providing... 

While Enghsh is the only MHRA-approved language, other language versions may be used upon certification of identical content. S)unbols, pictograms and educational material are also discussed. The MHRA guidance and appendices are essential reading for those required to write PILs, generally members of the medical department. 

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