Press release: Better Regulation of Medicines Initiative - third report launched

Press release

Date:	08 May 2008
Time:	09:00
Subject:	BROMI Third Report
Contact:	Press Office 020 7084 3535/3564 or press.office@mhra.gsi.gov.uk Out-of-hours 07770 446 189

The Medicines and Healthcare products Regulatory Agency (MHRA) is to publish its third report on the new and innovative scheme; Better Regulation of Medicines Initiative (BROMI) on 08 May 2008. BROMI is a ground breaking initiative which is changing medicines regulation in order to deliver new updated medicines to patients faster.

A year long pilot initiated in February 2007 to cut the regulatory burden on Variation Applications was carried out with a small group of pharmaceutical companies to test the feasibility of moving towards a self-certification model for certain types of variations. The results were very successful and the scheme was rolled out to the pharmaceutical industry on 1 April 2008, together with reduced fees.

It is envisaged that approximately 80% of Type I notifications will be processed through the self-certification scheme, which will be a huge benefit to industry - a saving of up to £100 million - and ultimately, benefit to patients.

BROMI has shown that medicines regulation can be targeted; risk based and proportionate and still deliver high levels of patient safety. The initiative has made steady progress since its publication of the first and second reports in May and December 2006 and is committed to making an impact on medicines regulation to the advantage of all stakeholders. Importantly, the principles of BROMI are reflected in new legislation proposed by the EU Commission.

Director of Vigilance and Risk Management of Medicines at the MHRA, Dr. June Raine said ‘Our third report shows that real progress has been made since BROMI’s introduction in 2005. The MHRA is on track to cut the amount of regulatory burden on industry via license variation processes, whilst achieving its fundamental objective of always putting patient safety first.’

Notes to Editor

• As with all new BROMI ways of working, the MHRA will be exercising its enforcement role in this area and where necessary may remove company privilege where there have been breaches of the scheme.
• The roll out of the new BROMI variations scheme will include a joint MHRA/industry training day on 08 May 2008.
• BROMI was originally set up to look at how unnecessary regulatory burdens, primarily in relation to over the counter (OTC) medicines, could be eased, whilst maintaining safeguards to protect public health; however, the scope of BROMI has now been extended to the entire pharmaceutical industry.
• The BROMI team won an EU better regulation award in October 2007- the Red Tape Reduction award, hosted and presented by the Standard Cost Model Network, in competition against 21 initiatives from across the EU.
• To view the report, please follow the hyperlink. www.mhra.gov.uk