China Plans Law Revisions To Encourage Orphan, Pediatric Drug Development

Ethics Review Changes Also

New draft rules outline market exclusivity provisions for orphan and pediatric drug development, along with mutual recognition of ethics reviews, in developments being seen as positive for the industry.

china implementing rules of drug administration law
proposed Implementing rules will add 101 articles to China's 2002 drug law • Source: Shutterstock

The Chinese government on 9 May issued proposals to amend the implementing rules of the existing national Drug Administration Law, the paramount legislation regulating the pharmaceutical industry in the country.

The changes are being perceived as providing new support and a renewed policy tailwind to Chinese drug makers, although the...

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