Implementation Measures for Protection of Drug Trial Data Released National Medical Products Administration: Innovative Drug Trial Data Protected for 6 Years

On May 15th, the State Drug Administration issued the "Implementation Measures for Drug Trial Data Protection". The measures stipulate that a 6-year data protection period will be granted from the date of the first domestic market approval for innovative drugs. For original research drugs that are already on the market overseas but not yet in the domestic market, a 6-year data protection period will be granted from the date of the first domestic market approval. When chemical drugs and biological products that meet the criteria are approved for marketing, the National Drug Administration will protect the trial data and other data submitted by the applicant that has been obtained independently and not disclosed for a data protection period of up to 6 years. The data protection period will be calculated from the date the drug registration application is approved domestically. The State Drug Administration Announcement on the Implementation Measures for Drug Trial Data Protection (No. 47 of 2026) is as follows: In order to promote drug innovation and improve the drug trial data protection system, in accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China," the "Regulations on the Implementation of the Drug Administration Law of the People's Republic of China," and other related regulations, the State Drug Administration has formulated the "Implementation Measures for Drug Trial Data Protection" (referred to as the "Implementation Measures") based on international experience, and is now published and implemented from the date of publication. The specific announcement is as follows: 1. From the date of publication of this announcement, drug registration applicants can simultaneously submit a drug trial data protection application when submitting a drug registration application. 2. For drug registration applications that have been accepted before the date of this announcement but have not yet been reviewed, if they meet the conditions for drug trial data protection as stipulated in the "Implementation Measures," the applicant shall submit a drug trial data protection application to the Drug Evaluation Center of the State Drug Administration within 15 days from the date of publication of this announcement and provide relevant materials. The specific requirements will be separately announced by the Drug Evaluation Center. Failure to submit within the specified time will be deemed as a waiver of drug trial data protection. If the review period is less than 20 days, the evaluation center will suspend the timer, resume timing after forming preliminary review opinions on drug trial data protection, and submit them to the State Drug Administration after completing technical reviews. Drugs that meet the conditions for drug trial data protection will be implemented in accordance with the relevant provisions of the "Implementation Measures." 3. For drug registration applications that have already entered the administrative approval stage but have not been approved, if they meet the conditions for drug trial data protection as stipulated in the "Implementation Measures," the applicant must submit a drug trial data protection application to the Drug Evaluation Center within 15 days from the date of publication of this announcement. From the date of publication of this announcement until the Drug Evaluation Center website announces the data protection information, drug registration applications that rely on the protected data will not be accepted or approved. This notice is hereby issued on May 15, 2026 by the State Drug Administration.