M4 module an administrative document and drug information !!!

Guide: CDE issues notice of "M4 Module, One Administrative Document and Drug Information"In accordance with the "Announcement of the State Drug Administration on the Implementation of <> Related Matters" (No46 of 2020), in order to promote the drafting of relevant supporting normative documents and technical guidelines, the Drug Administration, with the deployment of the State Drug Administration, the Drug Administration organization has formulated the "M4 Module 1 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 Drug Review CenterJuly 1, 2020M4 module an administrative document and drug information1.0 note letter (see attached: note)mainly for the application of key information summary and description1.1 Catalogsubmit the declaration catalogue separately according to the different modules1.2 Application Formmainly includes product names, dosage forms, specifications and application stakes and other product basic information1.3 Product Information Related Materials1.3.1 1.3.1.1 Research Drug Description and Revision Note (applying to Clinical Trial Applications) 1.3.1.2 Listed Drug Description and Revision Statement (applying to listing and post-listing change applications) overseas listed drugs are yet to be provided with the approval of the pharmaceutical regulatory agency of the overseas listed country or region, and attached to the Chinese 1.3.2 Packaging Labels 1.3.2.1 Research Drug Packaging Labels (for Clinical Trial Applications) 1.3.2.2 Listed Drug Packaging Labels (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 regions 1.3.3 Product Quality Standards and Production Processes/Manufacturing and Verification Procedures Submission of production process information forms and quality standards, biological products submitted to manufacturing and inspection procedures and quality standards when applying for the listing of chemicals 1.3.4 Clinical Trial Related Data (applying to Clinical Trial Applications) 1.3.4.1 Clinical Trial Plan and Program 1.3.4.2 Informed Consent Form 1.3.4.3 Researcher's Manual 1.3.4.5 Pharmaceutical General Name Approval Application Material
not included in the National Drug Standard or Drug Registration Standard, the application for a generic name of the drug shall be submitted to the application for approval of the generic name of the drug 1.3.6 Inspection related information (applicable to listing applications and supplementary applications related to 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 report 1.3.7 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 Packages Raw Materials, Pharmaceutical Accessories and Pharmaceutical Packages Legal Source Support Documents, including supply agreements, invoices, etc (apply to the case of unselected original accessories) 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 the statement that the patent of another person does not constitute 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 research and development project approval documents 1.3.8.4 Trademark Information and Support 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 Notices, Clinical Trial Drug Quality Standards and Clinical Trial Registration Number/Bioequivalent Test Registration Number (Internal Verification) 1.3.8.7 Certificate of Qualification of Research Institutions Non-Clinical Research Safety Evaluation Agency shall provide supporting documents such as approval certificates or inspection reports issued by the Drug Supervision and Administration Department that comply with the Code of Quality Management for Drug Non-Clinical Research (GLP) 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) a certificate of allowing the drug to be listed for sale, a notarized certification document and a Chinese translation issued by the overseas drug regulatory agency 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 Application Status (if applicable) 1.4.1 Past Approvals Provide information on the various applications related to the variety and approval/non-approval documents (internal verification) 1.4.2 applications to adjust clinical trial programs, suspend or terminate clinical trials 1.4.3 after the application to resume clinical trials 1.4.4 .4.5 Application for withdrawal of unapproved pharmaceutical clinical trial application, listing registration license application, supplementary application or re-registration application
1.4.6 Application for listing registration review period changes only include changes not related to the applicant's name, change of registration address name, etc 1.4.7 application for cancellation of drug registration certificate
1.5 accelerated listing registration procedure application (if applicable) 1.5.1 accelerated listing registration procedure
application Including breakthrough therapeutic drug procedures, conditional approval procedures, priority review and approval procedures 1.5.2 to expedite the listing registration procedure termination application 1.5.3 other accelerated registration procedures application 1.6 communication meeting (
1.6.1 meeting application 1.6.2 meeting background information 1.6.3 meeting related letters, meeting minutes and Clinical trial process management information (if applicable) 1.7.1 clinical trial searly increases indications 1.7.2 clinical trial scenario changes, non-clinical or pharmaceutical changes, or new findings may increase the risk of safety of subjects
1.7.3 requires the applicant to adjust the clinical trial program, suspend or terminate the drug clinical trial 1.8 drug alert and risk management (if applicable) 1.8.1 during the development of safety update reports and annexes
1.8.1.1 Safety Update Report for research and development 1.8.1.2 Cumulative Summary Of Serious Adverse Reactions (SAR) Summary 1.8.1.3 List of Dead Subjects in the Reporting Cycle List of Subjects Who Exited Clinical Trials due to Any Adverse Events in the 1.8.1.4 Reporting Cycle
1.8.1.5 Reporting Cycle 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 Information 1.8.3 Risk Management Plan (RMP) including drug alert activity planning and risk minimization measures 1.9 Post-marketing research (if applicable) including IV periods and studies with specific research purposes 1.10 After-market change (if applicable) 1.10.1 approval category change 1.10.2 Filing type change
change does not involve technical review of the drug registration certificate containing information, the overseas holder submits the documents of the permitted change issued by the drug regulatory agency in the country or region; 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 Applicant/Production Enterprise Proof Document
1.11.1 Domestic Production Drug Applicant/Production Enterprise Qualification Certificate Applicant/Production Enterprise Agency Legal Registration Certificate (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 applicants/production enterprises for overseas production of pharmaceuticals
supporting documents, notarized certification documents and Chinese translations of production 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 Certificate of Registration Agency
Where an overseas applicant designates an enterprise legal person in China to handle the relevant drug registration matters, it shall provide the entrustment document, notarized document and its Chinese translation, as well as a copy of the business license of the registered agency 1.12 Small MicroEnterprise Support Documents (if applicable) note: 1 The documents marked "If applicable" are submitted by the applicant in accordance with the characteristics of the declared drug, the application sought and the selection of applicable documents 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 attached: instruction letter xx application for XX products declared by XX company 1 Brief description but not limited to: product name, (proposed) indications, usage, dosage form, specifications 2 Background Information briefly describes the progress of domestic and foreign listing of the product, 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 attached: Vaccine Biosecurity and Environmental Impact Assessment for vaccines that do not contain living microorganisms or do not significantly alter the concentration and distribution of corresponding microorganisms and degradation products in nature, such as inactivated vaccines, polysaccharides, anti-toxic intake vaccines prepared by traditional methods, etc., only need to be described as the composition of the product, provide a statement that the products are non-environmentally active and do not require 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);