China Drug Registration Guidelines

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To protect public health and ensure that patients have access to safe and effective medicines, the National Medical Products Administration (NMPA) is legally in charge of drug registration in China. In this article, we analyze and interpret China's drug registration regulatory system to help manufacturers understand and respond to the requirements of drug registration in China.

Introduction of China Drug Registration

Drug registration in China refers to the activities of drug manufacturers or importers who submit applications for drug clinical trials, drug marketing authorization, re-registration, etc., as well as supplemental applications to the NMPA, and then go through a rigorous review process by the supervisory and regulatory authorities to decide whether or not to agree with their applications.

Drug registration aims to ensure that all marketed drugs meet safety, efficacy and quality standards. The process involves the applicant submitting detailed non-clinical and clinical trial data, as well as manufacturing and quality control information. The review department then evaluates the drug, including verification of the drug's efficacy, risks and labeling information.

Purpose of marketing authorization for pharmaceutical products

For the drug regulatory authority

To confirm whether the applicant is qualified as a marketing authorization holder (MAH) through the declared information
To ensure the safety, efficacy and quality control of the marketed drug

For the applicant

Obtaining marketing authorization for the drug is the last step before the drug is marketed
To carry out business activities such as the legal production and sale of drugs

Classification of drug registration

China's drug registration is categorized into Chinese medicine, chemical drugs and biological products.

Chinese medicines: classified according to innovative Chinese medicines, improved new Chinese medicines, compound preparations of traditional Chinese medicines with ancient classical prescriptions, and medicines with the same name and the same formula.

Chemical drugs: classified according to innovative chemical drugs, new and improved chemical drugs, generic drugs and so on.

Biological products: categorized according to innovative drugs for biological products, improved new drugs for biological products, and marketed biological products (including biosimilars).

Drug Registration Process

Drug preclinical studies

Pharmaceutical studies: confirm the composition of the prescription, impurities and stability, etc.

Pharmacological studies: assess the drug's biological activity and mechanism of action.

Toxicology studies: assess the safety of the drug, including acute and chronic toxicity tests, as well as the assessment of special toxicity (e.g. genotoxicity, carcinogenicity).

The results of preclinical studies will determine whether the drug can enter the clinical trial stage and serve as an important scientific basis for declaring the marketing authorization of the drug.

Clinical trial

Clinical trial application: submission of relevant research data in accordance with the requirements of the declaration of information.
CDE evaluation: decide whether to agree to conduct the trial within 60 days from the date of acceptance, and notify the applicant of the approval result through the CDE website. If no notification is made after the deadline, it shall be deemed consent.
The applicant is authorized to carry out a drug clinical trial.
Formulate the clinical trial program and pass the review by the Ethics Committee.
Conducting phase I/II/III/IV clinical trials and bioequivalence tests: the drug clinical trial shall be carried out within 3 years after approval.
Registration of clinical trial results.

Marketing authorization

Acceptance - within 5 days

The applicant shall submit the relevant declaration information according to the registration classification of the drug.

Evaluation - within 200 days

CDE organizes pharmacy, medical and other technical personnel to review the accepted applications for marketing authorization of drugs in accordance with the requirements, and initiates the verification and inspection of drug registration based on the risks during the review process.

Verification - 40 days before the completion of the evaluation

If CDE decides to initiate on-site verification of drug registration development and production, it will notify CFDI to organize and implement the verification during the review period, and CFDI will send the verification results and other materials back to CDE for a comprehensive review.

Inspection - within 60 days

Including standard review and sample testing. With the national drug standards contained in the same variety of drugs using the same test items and test methods, you only need to perform sample testing. Other cases should be standard reviews and sample tests.

Comprehensive review - within 20 days

CDE according to drug registration information, verification results, test results, etc., the safety, efficacy and quality control of the drug for a comprehensive review.

Approval - within 10 days

If the conclusion of the comprehensive review is passed, the drug is approved to be listed on the market and a certificate of drug registration is issued.

The following time is not counted in the relevant process time limit

(1) The time taken by the applicant for additional information, rectifying after verification, and checking the production process, quality standard and specification as required, etc.

(2) Time for delayed verification, inspection, convening of expert consultation meetings, etc., due to the applicant's reasons.

(3) According to the provisions of laws and regulations suspending the review and approval process, the time occupied during the suspension of the review and approval process.

Accelerated listing and registration procedures

Breakthrough therapeutic drug program

Innovative drugs or improved new drugs that prevent or treat diseases that seriously jeopardize life or quality of life and for which there is no effective means of prevention or treatment or that have obvious clinical advantages compared with existing means of treatment, etc.

Conditional approval program

Drugs for the treatment of serious life-threatening diseases for which there is no effective treatment, drugs urgently needed for public health, vaccines urgently needed for responding to major public health emergencies, and other vaccines recognized as urgently needed by the National Health Commission.

Priority review and approval procedures

Drugs in short supply, innovative and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases, new varieties, dosage forms and specifications of children's drugs, vaccines and innovative vaccines urgently needed for disease prevention and control, etc.

Special approval procedures

Drugs are required for the prevention and treatment of public health emergencies.

Post-market changes

According to the safety, efficacy and controllability of the quality of drugs and the degree of impact, the management of approval-type change, filing-type change and report-type change is implemented.

Re-registration

If the holder applies for re-registration 6 months before the expiration date of the certificate of registration, the review department will decide whether to re-register the drug based on the post-market evaluation and monitoring of adverse reactions.

As a trusted global regulatory compliance expert, Proregulations can accurately understand the procedural and technical aspects of drug registration in China, and provide pharmaceutical companies and importers with a full range of consulting and regulatory support related services. If you are interested in our services or need more details, please contact us.

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