Tuesday, October 30, 2012

USP releases global compendium of quality medicines

Demonstrating the ever-growing need for global public standards for the quality of medicines, the U.S. Pharmacopeial Convention (USP) announced the expansion of its Medicines Compendium (MC). 

The USP MC is a free, online resource of quality standards for medicines approved in any country.  It was launched in July of 2011 with one Expert Committee based in South Asia (India). 

The USP MC represents an innovative approach to make available good public testing standards for a marketed medicine and its ingredients. The USP MC provides monographs, general chapters, and allied reference materials for chemical and biologic medicines and their ingredients, including drug substances and excipients.

The early success of the MC has lead to the creation of two new Expert Committees (in addition to a second EC convened in January of this year in East Asia) and to the expansion and enhancement of the MC website.

"I have been gratified by advances of the Medicines Compendium during its first year," said Roger L. Williams, M.D., USP's chief executive officer.  "The MC's innovative approaches to monograph development utilize a multi-source procedure that may be used to test articles irrespective of manufacturing source.  The MC
development process also has paved a way to a more rapid and effective approach to creating standards.

The excellent work of the South Asia Expert Committee, chaired by Dr. Antony Raj Gomes, coupled with fine work by USP staff has created a strong foundation upon which we are now able to build."

USP's volunteer Expert Committees are the organization's scientific decision-making bodies for  its compendia.  In addition to the South Asia Expert Committee, seven Expert Committees have been approved to support the MC, of which four have been formed. 

The MC-East Asia Expert Committee, chaired by Dr. Jaisheng Tu, concentrates on excipients; the MC-Latin America EC, chaired by Dr. Maria Ines Rocha Miritello Santoro, will concentrate on chemical drug substances and dosage forms; and a fourth MC EC based in Asia and chaired by Dr. Dhananjay Patankar will focus on biologics.

Going forward, the MC may add further Expert Committees based in other parts of the world and focusing on other scientific areas as it becomes advisable.

With its broadened range of scientific expertise, the MC will become increasingly useful to manufacturers, purchasers, regulators, pharmacopeias, donor organizations and others worldwide seeking rigorous testing approaches where they otherwise might not exist or, should they exist, need updating. 

Documentary (written) standards in the MC may be freely adopted or adapted by any party, which supports countries striving to provide broader access to good-quality medicines and to combat substandard or counterfeit medicines.

For more information on the Medicines Compendium, please visit www.usp-mc.org/(PRNewswire/AsiaNet).

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