MHRA Drives for Regulatory Excellence - - BioPharm International

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MHRA Drives for Regulatory Excellence


BioPharm Bulletin

The Medicines and Healthcare products Regulatory Agency (MHRA) launched a public consultation on the consolidation of United Kingdom (UK) medicines legislation on Oct. 26, 2011. Seeking to greatly simplify and elucidate the law regulating medicines in the UK, the MHRA invited interested parties to contribute to legislation development. The consolidation will replace around 200 statutory instruments and much of the Medicines Act 1968 with the simplified, uniform Human Medicines Regulations.

In a press statement, MHRA Chief Executive, Sir Kent Woods, said, “Medicines legislation, which has been amended many times over several decades, can be greatly simplified by consolidation. The current need for this has received widespread support from both pharmacists and the pharmaceutical industry.

“It will amalgamate 40 years of outdated and fragmented legislation, reducing it by around two thirds, making it clearer and easier to understand as well as ensuring that medicines regulation is supported by a modern and straightforward legal framework.”

The consolidation is key to the MHRA’s Regulatory Excellence program, which examines regulations to ensure they are fit for purpose, and has the support of the Association of British Pharmaceutical Industry (ABPI). Stephen Whitehead, ABPI’s chief executive, said, “The ABPI welcomes this opportunity to contribute to providing clearer legislation and encourages our members to actively participate in the consultation.”

The consultation is open for 12 weeks, and comments are invited by Jan. 17, 2012.

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