Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 11 June 2012 | By Ansis Helmanis
China's State Food and Drug Administration (SFDA) issued draft rules on 4 June to require pharmaceutical manufacturers to establish a system of ensuring the quality of the excipients they use in their drug production.
Under the draft guidelines, drug manufacturers will explicitly have the primary responsibility to assure the quality of the excipients that they obtain from their excipient suppliers. The goal of the draft rules is to "realize the full supervision of the pharmaceutical production and supply chain."
SFDA - State Food and Drug Administration for public comment on the relevant provisions to strengthen the supervision and management of pharmaceutical excipients
More Breaking News from RegLink
Tags: Suppliers, Excipients, Supply Chain, State Food and Drug Administration, SFDA, regulation