USP is creating a China-focused East Asia expert committee to develop quality standards for excipients.
In June the US Pharmacopeia (USP) released details of its plans to create a free, online collection of voluntary public standards, called the Medicines Compendium (MC). The first ten standards were published last week and USP is working to expand the collection.
Roger Williams, CEO of USP, said: “It’s through the availability of public standards such as those developed for the MC that manufacturers of a given medicine or ingredient can meet the same fundamental requirements.”
Development of the first 10 standards was shaped by comments from USP staff and the MC South Asia expert committee. USP chose to create its first MC-focused body in South Asia because of India’s central role in exporting medicines and is now expanding the model.
The next committee is forming in East Asia and will be made up of Chinese scientists. Initially the committee will focus on developing quality standards for excipients. USP may also set up other committees in other regions.
The first wave
After a consultation period the USP has published standards for anti-HIV agents, antivirals and other drugs in the first wave of additions to its MC. The MC is intended to fill public health gaps and help manufacturers exporting drugs to countries with limited regulatory resources.
As such, the first wave of standards focuses on anti-malarials, anti-retrovirals and contraceptives. USP said the monograph for stibogluconate sodium, an anti-parasitic agent, is the first publically available standard for the drug.
A further five monographs, for treating sleeping sickness and other diseases, are now open for comments. After comments close later this year the USP will review feedback before publishing. For the first 10 standards there was two months between comments closing and publication.