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MHRA says BROMI on track

The Medicines and Healthcare products Regulatory Agency (MHRA) has published its third report into the Better Regulation of Medicines Initiative
The Medicines and Healthcare products Regulatory Agency (MHRA) has published its third report into the Better Regulation of Medicines Initiative (BROMI)

It says the scheme is on track to pass on huge benefits to the pharmaceutical industry, including savings of £100m. According to the MHRA, BROMI is helping change medicines regulation in order to get vital drugs to patients faster and reflects proposals put forward by the European Commission.

The report says that 80 per cent of type I notifications will be processed through a system of self-certification. In February 2007, a yearlong pilot scheme was launched to alleviate the burden of the regulatory environment on the pharmaceutical industry.

"Our third report shows that real progress has been made since BROMI's introduction in 2005," said director of vigilance and risk management of medicines at the agency, Dr June Raine. "The MHRA is on track to cut the amount of regulatory burden on industry via licence variation processes, whilst achieving its fundamental objective of always putting patient safety first."

BROMI was launched to the pharmaceutical industry on April 1, 2008, thanks to the success of the MHRA pilot programme.

8th May 2008

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