The Medicines and Healthcare Products Regulatory Agency’s groundbreaking initiative to speed the delivery of new updated medicines to patients has been extended to cover the entire pharmaceutical industry.

The Better Regulation of Medicines Initiative was originally set up to examine how unnecessary regulatory burdens, primarily in relation to over-the-counter medicines, could be eased. However, the initiative has now been extended to the innovative sector of the industry, says the MHRA, in its third annual report on BROMI.

The concept establishes a three-tier regulatory pyramid model, at the top of which are applications that can be self-certified by the company. Next are changes requiring prior assessment by a third party, and finally applications that will continue to require MHRA assessment. The further up the pyramid, the more the regulatory burden is reduced.

Wherever possible, administrative procedures have been simplified and barriers removed in areas such as changes to the details of Marketing Authorisations, changes to labels and leaflets, non-statutory changes to pack design, change of ownership from one company to another and duplicate MAs.

The 2008 progress report includes details of the self-certification scheme for minor changes to patient information that began in May 2006. With over 8,000 notifications received, no serious risks to public health have been found, it says. Also, a year-long pilot initiated in February 2007 to cut the regulatory burden by moving towards a self-certification model for certain types of variations proved to be very successful, and the scheme was rolled out to the entire industry on April 1, 2008, together with reduced fees.

£100M saving for industry
It is envisaged that approximately 80% of Type 1 notifications will be processed through the self-certification scheme, which will be a huge benefit to companies and the agency, and save the industry as much as £100 million, says the MHRA.

Companies have reported considerable benefits with the initiative. For example, Johnson & Johnson UK saved 8,000 euros in line efficiency last year by able to self-certify just one label change, for Sudafed, said the firm’s head of regulatory affairs, Gill Peckham. Before BROMI, even a minor label change had to be submitted to the MHRA, and the approval process could take up to five months with no flexibility, even though safety was not affected. But now, “because we self-certify, we could change it immediately,” she said.

Nicholas Smalley, regulatory affairs director at Perrigo, added that the faster process helped the company get a time-specific hay fever product to market nearly three months earlier than before, gaining the company an extra £20,000 a week in sales. "The valuable time now being saved by the reduction in red tape is also a tremendous advantage – it frees us up for new product development,” he said.

BROMI has achieved the first breakthroughs in simplifying the complex and time-consuming systems of medicines regulation built up since the thalidomide disaster, and has shown that medicines regulation can be targeted, risk-based and proportionate, and still deliver high levels of public safety, says the MHRA. Moreover, drugmakers are benefiting not only in lifting resource burdens but also in gaining market opportunities and empowerment, it adds.