Provisions for Drug Registration

Chapter X Supplementary Provisions

Article 120 Registration applications of narcotics, psychotropics, toxic substances for medical use, radiopharmaceuticals, pharmaceutical precursor chemicals and other drugs subject to special administration shall be handled not only in compliance with these Provisions but also with other relevant State regulations.

Article 121 Vaccines for export shall conform to the standards of the importing country (region) or the contractual requirements.

Article 122 For a drug-device combination product, where other products of the same category have been defined as drugs, drug registration application shall be submitted; where attribute of a product has not been defined, the applicant shall apply for product attribute definition to the NMPA before submitting the registration application. For a drug-device combination product defined as one with drug as the predominant part, its registration shall comply with the procedures specified in these Provisions; study data on the medical device part shall be reviewed by the Center of Medical Device Evaluation of NMPA (CMDE), which shall then forward its review conclusions to the CDE for comprehensive review.

Article 123 The format of drug approval numbers for drugs manufactured domestically is: 国药准字 H (Z, S) + 4-digit year + 4-digit serial number. The format of drug approval numbers for drugs manufactured in the Hong Kong SAR, Macau SAR and Taiwan region is: 国药准字 H (Z, S) C + 4-digit year + 4-digit serial number.

The format of drug approval numbers for drugs manufactured overseas is: 国药准字 H (Z, S) J + 4-digit year + 4-digit serial number.

In each case, H stands for a chemical drug, Z for a TCMs, and S for a biological product.

Drug approval numbers shall not change in the event of a post-marketing change of registration items.

Where there are separate Provisions for TCMs, those Provisions shall prevail.

Article 124 Electronic drug registration approval documents and electronic approval documents for active drug ingredients formulated by drug regulatory departments have the same legal effect as paper documents.

Article 125 The timelines stipulated in these Provisions shall be calculated in working days.

Article 126 These Provisions shall go into effect as of July 1, 2020. The Provisions for Drug Registration issued by the former State Food and Drug Administration Decree No.28 on July 10, 2007 shall be repealed at the same time.

Note: In case of any difference in interpretation between the English version and the Chinese version, the Chinese version shall prevail.