Medicines Compendium expands global reach through new expert committees, enhanced website

Responding to the ever-growing need for global public quality standards for medicines, the United States Pharmacopeial Convention (USP) announced the formation of three new Expert Committees for its Medicines Compendium (MC) and an expanded and enhanced website for the online-only compendium.

In addition to the initial Medicines Compendium—South Asia (MC-SA) expert committee formed in 2011 and chaired by Dr Antony Raj Gomas, USP has added the Medicines Compendium—East Asia (MC-EA) Expert Committee, chaired by Dr Jaisheng Tu; the Medicines Compendium—Latin America (MC-LA) Expert Committee, chaired by Dr Maria Ines Rocha Miritello Santoro; and the Medicines Compendium—Biologics (MC-BIO) Expert Committee chaired by Dr Dhananjay Patankar.

The first three expert committees comprise experts from the region on chemical medicines and excipients. The MC-BIO expert committee comprises experts on biologics and biosimilars from Argentina, Brazil, China, South Korea, and the UK, as well as biologics experts from India who were members of original MC-SA Expert Committee. USP may add up to four more MC Expert Committees based in other regions of the world and/or focusing on other scientific areas. The MC-SA Expert Committee also has expanded its membership to include experts from Pakistan and Bangladesh. A complete list of expert committee members can be found on the MC website.

USP also announced the expansion and enhancement of the MC website to incorporate extensive interactive capabilities that support stakeholder comments. New website functionality allows users to navigate more easily, instantly upload comments anonymously, and view monographs and comments on-screen in a new in-line format. In addition, expert committee meetings will be posted and users will be able to share and save content with printing and PDF tools.

“I am gratified by the advances of the Medicines Compendium during its first year and a half. The MC’s innovative approaches to monograph development allow USP to create monographs using a Reference Procedure that may be used to test articles from multiple manufacturers. The MC development process also has paved a way to a more rapid and effective approach to developing standards. The work of the Medicines Compendium Expert Committees, supported by USP staff in India, Brazil, China and the US, has created a strong foundation upon which we are now able to build,” said Roger L Williams, Chief Executive Officer, USP.

To date, approximately 70 monographs have been authorised for use, and over 30 more monographs are near final authorisation in the MC. An additional 180 more are in the initial for development phase. Among those authorised are monographs for Hepatitis B Vaccine; Esomeprazole Sodium, used to control acid in the stomach; and Pegfilgrastim, a treatment used to help patients fight infection when undergoing chemotherapy. Also recently authorised is a monograph for Rituximab, a monoclonal antibody used in the treatment of lymphoma, rheumatoid arthritis and other autoimmune disorders. This monograph is the first public standard for a monoclonal antibody available in the world. Among the other vaccine monographs currently under development is Haemophilus Influenza Type B Vaccine. Both vaccines are included on the List of World Health Organization Essential Medicines. Monographs also are in development for various dosage forms of Metamizole, an analgesic used extensively in Brazil and South America.

The 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 (EC) based in South Asia (India). The MC provides monographs, general chapters, and reference materials for chemical and biologic medicines and their ingredients, including drug substances and excipients.

EP News Bureau