Provisions for Drug Registration

Chapter II General Systems and Requirements

Article 8 The conduct of drug R&D and registration shall comply with applicable laws, regulations, rules, standards and norms. Relevant technical guidelines shall be referenced. Where alternative review methods and techniques are applied, they shall be demonstrated to be scientific and applicable. The authenticity, accuracy, integrity and traceability of information shall be ensured during the whole process.

Drugs shall meet the national drug standards and the drug standards approved by the NMPA. The drug standards approved by NMPA are adopted for drug registration. The drug registration standards shall meet the general technical requirements of the Pharmacopoeia of the People's Republic of China and shall not be lower than those prescribed in the Pharmacopoeia of the People's Republic of China. Where the Pharmacopoeia of the People's Republic of China is not applicable to a product applying for registration with regard to the testing items or criteria, the applicant shall provide sufficient supporting data.

Specialized technical institutions including the CDE shall develop technical guidelines and procedures according to scientific progress, industry development and the needs for drug supervision and administration, and release them to the public.

Article 9 Applicants shall be enterprises or drug R&D institutions that can undertake corresponding legal liability. Overseas applicants shall designate an enterprise legal person within the territory of the People's Republic of China to handle matters relating to drug registration.

Article 10 Before applying for marketing registration of a drug, the applicant shall complete related research including Chemical, Manufacturing and Control (CMC), pharmacological and toxicological studies and drug clinical trials. Non-clinical safety evaluation studies shall be carried out in institutions meeting Good Laboratory Practice (GLP) requirements and be in compliance with the GLP. Drug clinical trials shall be approved, and bioequivalence studies shall be filed for record. Drug clinical trials shall be carried out in clinical trial institutions that comply with relevant regulations and adhere to the Good Clinical Practice (GCP).

To apply for drug registration, authentic, sufficient and reliable data, documents and samples shall be provided to demonstrate the safety, efficacy and quality of the drugs.

Where overseas research dossiers and data are used to support drug registration, their sources, research institutions or laboratory conditions, quality system requirements and other management conditions shall conform to the general principles of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), and to China's relevant requirements for drug registration.

Article 11 To make any change to the items or contents specified in the original drug registration approval document and its attachments, the applicant shall, in accordance with regulations and with reference to relevant technical guidelines, fully study and validate the change, fully assess the potential impact of the change on the safety, efficacy and quality of the drug, and then submit a supplementary application, filing or report as per the applicable change procedures.

Article 12 The term of validity for the Drug Approval License is 5 years. An MAH shall continually ensure the safety, efficacy and quality of the drug during the term of validity and apply for registration renewal 6 months prior to the expiration date.

Article 13 The NMPA shall establish an expedited registration system for drug marketing to support drug innovation guided by clinical value. For a drug registration application that meet relevant conditions, the applicant may apply for the breakthrough therapy drug procedure, the conditional approval procedure, the priority review and approval procedure or the special review and approval procedure and, during the process of drug R&D and registration, drug regulatory departments and their specialized technical institutions shall provide policy and technical support including necessary technical guidance, communication, priority allocation of resources, shortening the review timeline, etc.

Article 14 The NMPA shall establish a bundling review and approval system for chemical active drug ingredients, excipients and primary packaging materials and containers. When reviewing and approving drug products, the review and approval for the chemical active drug ingredients and review for the relevant excipients and primary packaging materials and containers shall be carried out together. The CDE shall establish a platform for registries of chemical active drug ingredients, excipients and primary packaging materials and containers, release relevant registry information to applicants or MAHs for their selection, and conduct the bundling review when reviewing registration applications of relevant drug products.

Article 15 Prescription drugs and non-prescription drugs shall be subject to classified registration and conversion management. The CDE shall, according to the characteristics of non-prescription drugs, formulate relevant technical guidelines and procedures for the marketing registration of non-prescription drugs and disclose them to the public. The CDR shall formulate relevant technical requirements and procedures for post-marketing conversion of prescription drugs and non-prescription drugs, and disclose them to the public.

Article 16 At critical points such as before submitting the application for drug clinical trials, during the drug clinical trials and before submitting the application for drug marketing authorization, the applicant may communicate and consult with the CDE and other specialized technical institutions about major issues. During the process of drug registration, the CDE and other specialized technical institutions may organize meetings to communicate with the applicant as needed for work.

The consultation and communication procedure, requirements and timeline shall be formulated separately by the CDE and other specialized technical institutions according to their respective functions and disclosed to the public.

Article 17 The CDE and other specialized technical institutions shall, if necessary, establish an expert advisory system, set up an expert advisory committee, listen to experts' opinions on major issues during the process of review, inspection, testing, and adopted name approval, and bring into full play the technical support role of experts.

Article 18 The NMPA shall establish a catalogue for chemical drugs that are newly approved for marketing and that have passed the generics consistency evaluation of quality and efficacy. The catalogue shall specify related information including drug names, active drug ingredients, dosage forms, strengths, whether they are references, MAHs, etc., and be updated promptly and published to the public. The inclusion procedure and requirements for the chemical drugs catalogue shall be formulated by the CDE and disclosed to the public.

Article 19 The NMPA supports the inheritance and innovation of TCMs, establishes and improves the registration administration system and technical evaluation system that are applicable to the characteristics of TCMs, encourages the application of modern science and technology and traditional research methods in the R&D of TCMs, strengthens the quality control of TCMs, and improves the level of clinical trials of TCMs.

To apply for registration of TCMs, the applicant shall evaluate the clinical values and resources so as to highlight the importance of clinical values and promote sustainable utilization of resources.