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China NMPA Grants 6-Year Data Protection Period for Innovative and Originator Drugs
China's National Medical Products Administration (NMPA) has issued the "Implementation Measures for Drug Trial Data Protection," which takes effect immediately. Drug registration a...
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China's National Medical Products Administration (NMPA) has issued the "Implementation Measures for Drug Trial Data Protection," which takes effect immediately. Drug registration applicants may, at the time of submitting a drug registration application, also apply for protection of drug trial data. This marks the first comprehensive revision of the regulation in more than 20 years since its implementation.

The measures stipulate a six-year protection period for trial data of innovative drugs and originator drugs; a four-year protection period for trial data of improved new drugs; and a three-year protection period for trial data of first generic drugs. During the data protection period, if other applicants apply for marketing authorization by relying on the protected data without the consent of the data holder, the NMPA will neither accept nor approve such applications.

The NMPA stated that following the revision, the regulatory framework has shifted from a model centered on the management of drug manufacturing and distribution enterprises to one centered on marketing authorization holders, strengthening strict supervision across the entire lifecycle of drugs. (jl/u)

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