中银国际-医药行业更新报告-

16 March 2007 (Friday) 2页 英文

SFDA revises medicine registration management rules.
On 10 March 2007, the State Food and Drug Administration (SFDA)
issued on its website a draft report on medicine registration
management rules to seek opinions over the next two months. The
medicine registration management rules define new medicines and
the rights of their owners. It also gives a guidance on how to obtain
certifications for drugs and ways to meet other necessary requirements.
The draft looks into ways to prevent the government from abusing its
powers. It also defines new drugs (those that have never been sold in
the country). Under the draft regulation, medicines in fresh packages
and of new specifications will not be deemed to be new products