CDE issues a circular on the "M4 Module, An Administrative Document and Drug Information".

In accordance with the "State Drug Administration Announcement on the Implementation of <> Related Matters" (No46 of 2020), in order to promote the drafting of relevant supporting normative documents, technical guidelines, the State Drug Administration, the deployment of the Drug Enforcement Agency, the Drug Control Center organized the development of "M4 module an administrative document and drug information" (see annex)In accordance with the requirements of the Notice of the General Division of the State Drug Administration on the Procedures for the Issuance of Technical Guidelines for the Issuance of Drugs (FDA No9 of 2020), it is hereby issued with the approval of the State Drug Administration and shall come into effect on July 1, 2020hereby hereby noticethe National Drug Administration's Drug Review CenterJuly 1, 2020
is mainly for the summary and description of the key information of this applicationsubmit separate catalogues of reporting materials according to different modulesmainly includes product name, dosage form, specifications and application matters and other product basic information1.3.11.3.1.1 Research Drug Description and Revision Note (applicable to Clinical Trial Applications)1.3.1.2 Listed Drug Description and Revision Statement (applying to listing and post-market change applications)The original specification for overseas listed drugs to be approved by the drug regulatory agency of the overseas listed country or region, and accompanied by a Chinese translation1.3.2 Packaging Label
1.3.2.1 Research Drug Packaging Label (for Clinical Trial Applications)1.3.2.2 Listed Drug Packaging Label (for listing and post-market change applications)overseas listed drugs still need to provide a true sample of packaging labels for overseas listed countries or regions1.3.3 Product Quality Standards and Production Processes/Manufacturing and Verification ProceduresProduction Process Information Forms and Quality Standards submitted to chemical products when applying for the market, biological products submitted to manufacturing and verification procedures and quality standards1.3.4 Clinical Trial Related Data (applying for Clinical Trial Applications)1.3.4.1 Clinical Trial Plan and Program1.3.4.2 Informed Consent Form
1.3.4.3 Researcher's Manual
1.3.5 Pharmaceutical General Name Approval Application Materials
not included in the National Drug Standard s/ Drug Registration Standards, the listing license application shall be submitted to the drug generic name approval application materials1.3.6 Check relevant information (applicable to listing applications and supplementary applications involving inspection and testing)including drug development information sheet, drug production information sheet, on-site master document list, drug registration clinical trial research information sheet, clinical trial information table and test report1.3.7 Vaccine Biosafety and Environmental Impact Assessment (see attached: Vaccine Biosafety and Environmental Impact Assessment)1.3.8 Product Related Certification Documents (if applicable)1.3.8.1 Raw Materials, Pharmaceutical Accessories and Pharmaceutical PackagesRaw Materials, Pharmaceutical Accessories and Pharmaceutical Packages Legal Source Support Documents, including supply agreements, invoices, etc(apply to the case of unselected original supplements) the authorized use of raw materials, pharmaceutical accessories and pharmaceutical packages (for the selection of the original auxiliary package of preparations) 1.3.8.2 Patent information and supporting documents the patent status and state of ownership of the applied drug or prescription, process, use, etc., and a statement that the patent of another person does not constitute an infringement 1.3.8.3 Approval documents for the development of special drugs narcotic drugs and psychotropic substances are required to provide copies of the approval documents for the development project 1.3.8.4 Trademark Information and SupportIng Documents
1.3.8.5 Supporting Documents of The Source of Control Drugs
1.3.8.6 Supporting Documents for Drug Clinical Trials (applicable to Listing Applications) "Pharmaceutical Clinical Trial Approvals" / Clinical Trial Notice, Clinical Trial Drug Quality Standards and Clinical Trial Registration Standards/Bioequivalent Test Registration Number (Internal Verification) 1.3.8.7 The certificate of qualification of the research institution the non-clinical research safety evaluation institution shall provide the supporting documents such as the approval certificate or inspection report issued by the drug supervision and administration department that complies with the Quality Management Practice s(GLP) of the Drug Non-Clinical Research Clinical trial institutions should provide a certificate of filing (internal verification) 1.3.8.8 Certificate documents related to pharmaceutical combination products, if they belong to pharmaceutical or pharmaceutical-based pharmaceutical combination products, shall submit a notice of the property definition results of the pharmaceutical combination product (internal verification) 1.3.8.9 The certificate of the sale of a drug (applicable to a drug listed abroad) is the document signed by the overseas drug regulatory agency to allow the drug to be listed for sale, notarized certification document and Chinese translation 1.3.8.10 Support documents that allow drug changes, supporting documents issued by overseas drug regulatory agencies that allow drug changes, notarized certification documents and translations of Chinese 1.3.9 Other Product Information Related Materials 1.4.1 Past Approvals
Providing The Status Statement of previous applications related to the variety and Approval/Unapproved Documents (Internal Verification) 1.4.2 Application to Adjust clinical trial programs, suspend or terminate clinical trials
1.4.3 After suspension 1.4.3 Application sand on the resumption
of clinical trials 1.4.4 Clinical trial application, listing registration license application, supplementary application or re-registration application 1.4.6 application listing registration review period changes only include the applicant's name change, change registration address name and other changes not related to the technical review content
1.4.7 application for cancellation of the drug registration certificate
1.5.1 to expedite the listing registration procedure application
including breakthrough treatment drug approval procedures, priority approval process and special approval procedures 1.5.2 Accelerated Listing Registration Procedure Termination Application 1.5.3 Other Expedited Registration Procedure Application
1.6.1 Conference Background Information
1.6.2 Conference Background information
1.6.3 Conference-related letters, minutes and responses 1.7.1 Increasein Indications 1.7.2 Clinical Trial Program Changes, Non-Clinical Or Pharmaceutical Changes or New Findings May Increase Subjects Safety Risk 1.7.3 requires the applicant to adjust the clinical trial program, suspend or terminate the drug clinical trial 1.8.1 safety update report during the development period and the 1.8.1.1 safety update report during the development 1.8.1.2 Serious Adverse Reactions (SAR) Cumulative Summary Table
1.8.1.3 List of dead subjects in the reporting cycle
1.8.1.4 List of subjects who have withdrawn from clinical trials due to any adverse events in the reporting cycle
1.8.1.5 Changes in drug clinical trial scenarios or new findings in clinical areas, non-clinical or pharmaceutical changes, or new findings summary form 1.8.1.6 Summary of the overall research plan for the next reporting cycle
1.8.2 Other Potential Serious Safety
Risk Programs (RMP ) including 1.8.3 Risk Management Programs (RMP) include IV periods and studies with specific research purposes 1.10.1 1.10.2 Registration changes changes the information contained in the drug registration certificate that does not involve technical review, the overseas holder submits the supporting documents for the permitting change issued by the drug regulatory agency in the country or region in which it is based; the application for sub-packaging of drugs shall be submitted in sub-packaging contracts (including authorization simply for the use of imported pharmaceutical trademarks), sub-packaging production enterprises "drug production licenses", sub-packaging processes, packaging materials and containers in direct contact with pharmaceuticals selection basis and quality standards 1.10.3 Reporting Category Change
1.11.1 Domestic Certificate of Qualification of The Applicant/Production Enterprise The Certificate of Legal Registration of the Applicant/Production Enterprise Institution (Business License, etc.) When applying for a drug listing license, the applicant and the production enterprise shall have obtained the corresponding Drug Production License (internal verification) if apply for a clinical trial, it shall provide a description of the preparation of the drugs used in clinical trials under conditions that comply with the quality management practices of pharmaceutical production 1.11.2 Certificates of qualification of overseas pharmaceutical applicants/production enterprises supporting documents, notarized certification documents and Chinese translations of production plants and packaging plants that comply with the quality management norms of pharmaceutical production if apply for a clinical trial, it shall provide a description of the preparation of the drugs used in clinical trials under conditions that comply with the quality management practices of pharmaceutical production 1.11.3 If the documents of the registered agency the overseas applicant designates the legal person of an enterprise in China to handle the relevant drug registration matters, it shall provide the entrustment document, the notarized document and the translation of its Chinese, as well as a copy of the business license of the registered agency Note: 1 The document marked "if applicable" is submitted by the applicant in accordance with the characteristics of the declared drug, the application for which it is declared and the applicable document in accordance with the requirements of the drug's full life cycle management 2 Documents marked "internal verification" refer to the documents that the regulatory authorities need to review and do not force the applicant to submit 3 If the supporting documents issued by the overseas drug regulatory agency or region submitted by the overseas production of drugs (including the documents allowing the sale of drugs on the market, the gmp supporting documents and the documents that allow drug changes, etc.) conform to the originals of the unified format recommended by the World Health Organization, they may be certified without notarization by the notary institution of the host country and the Chinese embassy and consulate in the host country xx application for XX products declared by XX company 1 Brief description including but not limited to: product name, (proposed) indications, usage, dosage form, specifications 2 Background information briefly describes the progress of the product's domestic and foreign listing, registration classification and basis, application matters and related supportive research expedited applications for the listing registration process (including breakthrough therapeutic drug procedures, conditional approval procedures, priority review and approval procedures, and special approval procedures) and their basis (if applicable) additional applications, such as clinical, over-the-counter, or children's medication relief, if applicable 3 Other important information to be specified
for vaccines that do not contain live microorganisms or do not significantly alter the concentration and distribution of corresponding microorganisms and their metabolism, degradation products in nature, such as inactivated vaccines, polysaccharides, live detoxification vaccines prepared by traditional methods, etc., only need to explain the composition of the products, provide products without environmental impact risk, no need to take preventive and preventive measures for products and their metabolism, degradation products may have a certain growth and reproduction in the human body and the environment of vaccines, such as vector vaccines, gene-modified live vaccines, etc., should carry out biosecurity and environmental impact assessment, analysis of such products in use, storage, disposal process and after the toxic effects of the breeder on human health and the environment (including dynamics, plants), in the whole life cycle of the vaccine market to assess environmental risks and provide prevention and control measures the following research materials are provided in the application for clinical trials: (1) the key modification methods, host range, transmission path, pathogenicity and type of added substances contained in the products, etc., to analyze their genetic stability and possible impact on the environment (2) The degree of identification and method of identification of vaccine strains/strains and wild strains (3) Evaluation of the sensitivity or resistance of the products and their metabolism and degradation products to the physical and chemical factors, the establishment of effective control measures in the body of the accident (4) the study of toxicity in animals, including the detoxification time of products and metabolism, the detoxification of degradation products, the number of detoxifications, the viability of the environment after detoxification, the evaluation of susceptible species, the risk of re-allocation or re-entry the application stage of listing needs to provide the following research data: (1) the human body after vaccination detox time, detox number, detox after the analysis and evaluation of human and animal disease strain; (2) Combining the research data during clinical trials, comprehensive analysis of environmental impact risks and proposed environmental risk prevention and control measures will be subject to continuous research in accordance with the post-market biosafety monitoring and risk assessment plan, including the organization of strain monitoring (e.g., differences in circulating strains or strains, strains or strain substitutions);