Breaking News on Global Pharmaceutical Technology & Manufacturing

Headlines > Regulatory & Safety

SFDA says global pharmacopoeias must develop rigorous testing methods

By Gareth Macdonald , 13-Sep-2012
Last updated the 13-Sep-2012 at 14:38 GMT

Pharmacopoeial standards authorities must cooperate to develop rigorous quality standards for drugs in an increasingly globalised market, according to the SFDA.

Chinese Food and Drug Administration (SFDA) Commissioner Yin Li made the comments at the fifth joint Chinese Pharmacopoeia Commission (ChP) and the United States Pharmacopeial Convention (USP) meeting, which was held in Xi’an, central China earlier this month.

Li said that: “The pharmacopoeial standards setting authorities’ common responsibility to develop rigorous scientific drug quality standards and ensure drug safety and effectiveness for the public.

Under the new situation of the globalization of drug production and distribution, the methods of continuous improvement of pharmacopoeial standards international cooperation mechanism and deepening drug standards substantial cooperation should be applied to strengthen international cooperation and coordination on drug standards.”

The comments come as China moves to improve the quality of the drug ingredients, intermediates and excipients produced there after numerous high profile scandals - such as the recent revelation that cooking oil is being used to make antibiotics – have started to raise doubts about the wisdom of sourcing ingredients in the country.

In recent months, the Beijing-headquartered SFDA has threatened to name and shame drug manufacturers that breach quality rules and issued strict guidance for the quality of excipients used in pharmaceutical products .

The latter guideline – like Yin Li’s latest comments about the role pharmacopoeial standards groups – appears to place more of the burden for ensuring drug quality on organisations other than itself.

Most pharmacopoial standards groups are already working on standards in China. In June last year for example the US Pharmacopoeia set up a dedicated committee to look at the quality of excipients produced in the country.

Key Industry Events

 

Access all events listing

Our events, Events from partners...