The UK’s drug regulatory agency, the Medicines and Healthcare products Regulatory Agency (MHRA) and the British Generic Manufacturers Association (BGMA) announced on 16 April 2014 the launch of a new forum to promote the manufacturing quality of generics.
The BGMA’s Technical Director, Mr Paul Fleming, said the idea is to increase understanding of regulatory requirements and ensure that both generics makers and regulators are up to date on the latest information in each other’s spheres. While the MHRA said that they were ‘pleased’ with the industry initiative and were ‘keen to share knowledge and expertise so that companies can fully understand the regulatory environment in which they operate’. Topics that the forum intends to address include current MHRA approaches to inspection and the auditing that companies perform themselves.
The forum is open to BGMA members and associates and will bring together the MHRA, generics manufacturers and providers of manufacturing and quality control services, meeting three times a year. The first meeting is planned for 4 June 2014 and a second meeting is planned for 12 November 2014.
According to the BGMA, more than two thirds of all medicines dispensed by the UK’s National Health Service are generics, saving more than GBP 11 billion in England and Wales alone.
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Source: www.gabionline.net
