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MHRA publishes fourth BROMI Report

Progress of the MHRA's programme of work to strip away unnecessary regulatory burdens is reviewed

The MHRA (Medicines and Healthcare products Regulatory Agency) has published its fourth Better Regulation of Medicines Initiative (BROMI) report. The report reviews progress since May 2008 in the three work streams: patient information, authorisation and pharmacovigilance, and notes the main milestones achieved since the last report. These include the success of BROMI at the National Business Awards in November 2008, the agreement of the third party pre-approval scheme for changes to pack design for patient information as a mainstream procedure, the foundation for the new variations legislation, effective in January 2010, and the exciting initiatives underway in the pharmacovigilance work stream. The report also sets out a programme of work to ensure BROMI continues to deliver in the future. 

Described as "a groundbreaking programme of work designed to strip away unnecessary regulatory burdens in relation to medicines," BROMI shows that medicines regulation can be targeted, risk-based and proportionate, yet still deliver high levels of patient safety.  

According to the report, "the BROMI approach" has become embedded within the MHRA, with benefits for industry, regulators and patients. Internal safeguards such as quality audit systems and sanctions have been introduced to safeguard the introduction of the new ways of working.

15th September 2009

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