Wednesday, 11 November 2015

History of MHRA & Orange Guide

HISTORY of MHRA & Orange Guide

History of MHRA

1 April 2003
Preceding agencies
Medicines Control Agency
Medical Devices Agency

The Medicines and Healthcare products Regulatory Agency (MHRA) is a government body head quartered in London. The agency is responsible for safeguarding public’s health in UK, which regulates medicines, medical devices and blood components for transfusion in the UK.

The Medicines and Healthcare Products Regulatory Agency was formed in 2003 with the merger of the Medicines Control Agency (MCA) and the Medical Devices Agency (MDA). In April 2013, it merged with the National Institute for Biological Standards and Control (NIBSC) and was rebranded, with the MHRA identity being used solely for the regulatory the centre within the group. The agency employs over 1200 people.

The MHRA is funded by the Department of Health for the regulation of medical devices, whilst the costs of medicines regulation is met through fees from the pharmaceutical industry.
The Agency has the power to withdraw a product from the market, and in the case of medicines, to suspend production. The Agency can also prosecute a manufacturer or distributor in the event of GMP violations.

The MHRA works closely with the European regulator, the European Medicines Agency (EMEA), The MHRA also collaborates with other international regulators, such as the US Food and Drug Administration (FDA), and UK government agencies involved in healthcare, including the National Patient Safety Agency (NPSA) and the National Institute for Health and Clinical Excellence (NICE).

History of Orange Guide

Orange guide was first published in 1971.Original orange guide contained British Good Manufacturing Practice and was entitled “Guide to Good Pharmaceutical Manufacturing Practice”. Later editions followed in 1977 and 1983, with detailed requirements for manufacturing sites. 

After the formation of European Union in 1993,EU GMP was created using the leading two written GMPs of Europe at that time, namely those of the British and the French.
From the mid-1990 the UK’s Regulatory Authority continued to publish the “Orange Guide”, but it now contained EU GMP rather than British GMP.  This is still the case today.  In addition that Good Distribution Practice (GDP) has also made its way into the book.   The book was published again in 1997, 2002 and then 2007.  As it is still published in a book with an orange cover the nick-name of the Orange Guide remains today. 

8th edition of orange guide is published in 2014.Current available orange guide is published in 2015. At present orange guide is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK. The current  Orange Guide combines the major pharmaceutical regulations, directives and guidance. It provides up-to-date European guidance on good manufacturing and distribution practice along with relevant information on European and UK legislation.

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