China adds 30 drugs to its "urgently needed" list

Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications

On 28 March China's National Medical Products Administration (NMPA) published a list of an additional 30 drugs that are "urgently needed" in China, and for which NMPA seeks to encourage the submission of marketing applications.

To that end, the agency has:

  • Waived the requirement to conduct clinical trials in China, if the sponsor has data demonstrating that racial or ethnic differences between the study population and Chinese patients would not affect the product's efficacy.
  • Established an expedited six-month review period (three months for orphan drugs) for the identified drugs.

Read More: China adds 30 drugs to its "urgently needed" list


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