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The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are acceptably safe.
鈥?MHRA was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA).
鈥?In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with MHRA identity being used solely for the regulatory centre within the group. The Agency employs more than 1,300
鈥?It was located in Vauxhall Wholesale New Orleans Pelicans Jerseys , London and is now relocated to 151 Buckingham Palace Rd, London SW1W9.
History
鈥?In 1999, the Medicines Control Agency (MCA) took over control of the General Practice Research Database (GPRD) from Office for National Statistics.
鈥?Medicines Control Agency (MCA) and the Medical Devices Agency (MDA) merged in 2003 to form MHRA. In April 2012, the GPRD was expanded and relaunched as the Clinical Practice Research Datalink (CPRD).
鈥?In April 2013 Wholesale Pelicans Jerseys , MHRA merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with MHRA identity being used for the parent organisation and one of the centres within the group. At the same time CPRD was formally declared a separate centre of MHRA, too.
Structure
MHRA is divided into three main centres:
鈥?MHRA Regulatory (the regulator for the pharmaceutical and medical devices industries)
鈥?Clinical Practice Research Datalink
鈥?National Institute for Biological Standards and Control
Aims
鈥?Protect the public health
鈥?Promoting the public health
鈥?Improving the public health
Objectives
鈥?Safeguard public health by ensuring that the products we regulate meet required standards and are acceptably safe,
鈥?Communicating accurate Cheap New Orleans Pelicans Jerseys , timely and authoritative information to healthcare professionals, patients and the public.
鈥?Support research and ensure that Better Regulation principles so that regulation does not stifle innovation,
鈥?Influence the shape of the future regulatory framework through effective European and International relationships,
鈥?Run an organization with a skilled and equipped workforce that is fit for the future.
Roles
鈥?Operate post-marketing surveillance for reporting Cheap Pelicans Jerseys , investigating and monitoring of adverse drug reactions to medicines and incidents with medical devices.
鈥?Assessment and authorisation of medicinal products for sale and supply in UK.
鈥?Oversee the Notified Bodies that ensure medical device manufacturers comply with regulatory requirements before putting devices on the market.
鈥?Operate a quality surveillance system to sample and test medicines to address quality defects and to monitor the safety and quality of unlicensed products.
鈥?Investigate internet sales and potential counterfeiting of medicines, and prosecute where necessary.
鈥?Provide Regulatory Training & eCTD Training
鈥?Regulate clinical trials of medicines and medical devices.
鈥?Monitor and ensure compliance with statutory obligations relating to medicines and medical devices.
鈥?Promote safe use of medicines and devices.
Funding
MHRA is funded by the Department of Health and Social Carefor the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry. This has led to suggestions by some MPs that MHRA is too reliant on industry, and so not fully independent.
Types of applications
1) Full applications
Applications for new active substances are described as 'full applications'.
2) Abridged applications
飩?Applications for medicines containing existing active substances are described as 'abbreviated鈥?or 鈥榓bridged applications鈥?
飩?Existing drugs with new forms Wholesale E’Twaun Moore Jersey , routes and indications. Sometimes, although the drug is the same, the new product has a different strength or pharmaceutical form or is used by a different route or for different clinical uses
飩?Existing drugs in new combinations may also be proposed though they may need a full data package to support them.
飩?鈥榃ell-established鈥?drugs and products - The new product may include a drug substance which has such a well-established medicinal use and an acceptable level of safety that the applicant company can submit published data to support the safety and efficacy aspects of their application. Examples here may include some over-the-counter (OTC) remedies.
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