UK industry/MHRA generics quality forum

[COLOR="#000000"]The British Generics Manufacturers Association (BGMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have established a new forum with the aim of ensuring the manufacturing quality of generic drugs in the UK.

The forum will meet three times a years to share and discuss the latest issues which impact on the quality of generics. The group will bring together the MHRA, generics manufacturers and providers of manufacturing and quality control services. Topics to be covered will include the Agency’s current approaches to inspection, trends and the auditing that companies perform themselves.

Commenting on the initiative, BGMA technical director Paul Fleming said: “as regulatory requirements and supply chains become ever more complex, supporting high quality standards is vitally important for the pharmaceutical industry, patients and the value we deliver to the NHS. From a generic medicines perspective, we wanted to launch something that was closely aligned with the regulator in order to increase mutual understanding as well as share the latest information quickly and easily.”

“Quality is a key component in ensuring that patients get their medicines in a timely and affordable manner. Our forum will provide a vital conduit between industry and the regulator on a topic which is critically important to the successful operation of the generic medicines marketplace in the UK, Europe and internationally,” he added.[/color]