UK Drug Groups Launch Generic Medicines Forum

The UK’s Medicines and Healthcare products Regulatory Agency and the British Generic Manufacturers Association will launch a forum to promote manufacturing quality in June.

Paul Fleming, BGMA technical director, said the idea is to increase understanding of regulatory requirements and ensure that both generic drugmakers and regulators are up to date on the latest information in each other’s spheres. Among the topics the forum will address:

• Data integrity and actions companies can take to protect it at home and abroad;
• The role of the MHRA Compliance Management Team in early warnings about concerns;
• How companies can improve and perform audits more effectively, including challenges from different types of audits, such as contract manufacturers, contract laboratories and company facilities in Third World countries;
• How to integrate company audits and MHRA inspection results;
• MHRA inspection standards and trends; and
• The impact of the Falsified Medicines Directive.

The forum is open to BGMA members and associates. The first meeting will take place June 4, with a second planned in November.

According to the trade group, more than two-thirds of all medicines prescribed by the National Health Service are generics, saving England and Wales alone a total of $18.5 billion. — Lena Freund

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