Please check it! Chemical registration classification and reporting information requirements.

Introduction: Notice of the State Drug Administration on the requirements for the publication of the classification and declaration of chemical sist registration (No44 of 2020)In cooperation with the implementation of the Measures for the Administration of Drug Registration, the State Drug Administration has formulated the Requirements for classification and declaration of chemical drug registration, which are hereby issued and described belowOn the classification of chemical sisphenomic registration, it will be implemented from July 1, 20202The requirements for the registration and declaration of chemicals shall be implemented from October 1, 2020By September 30, 2020, the filing of the information may be submitted as requiredhereby hereby noticeAnnex: Chemical Registration Classification and Reporting Materials Requirementsthe State Drug AdministrationJune 29, 2020Annex:Chemical Sisanoic Registration Classification and Declaration Information Requirements, Chemical Sist Registration ClassificationChemical Sisathing Registration Classification is divided into innovative drugs, improved new drugs, generic drugs, overseas listed domestic unlisted chemicals, divided into the following five categories:Refers to a drug that contains a new structured compound with pharmacological effects and has clinical valueCategory 2: No new modified drugs are listed at home or abroad On the basis of known active ingredients, the structure, dosage form, prescription process, route of administration, indications and other drugs are optimized, and have obvious clinical advantages 2.1 contains optical isomers of known active ingredients manufactured by splitting or synthesis, either as esters of known active ingredients, or salts containing hydrogen or ligation bonds, or acid roots, bases or metal elements that alter known salt active ingredients, or to form other non-covalent bond derivatives (e.g rheumatoids, chelates, or envelopes) 2.2 New dosage forms containing known active ingredients (including new dosing systems), new prescription processes, new routes of administration, and drugs with obvious clinical advantages 2.3 contains new compound formulations with known active ingredients, and has obvious clinical advantages 2.4 New Indications Drugs containing known active ingredients 3 categories: domestic applicants copy drugs listed abroad but not listed in China These drugs should be consistent with the quality and efficacy of the reference formulation 4 categories: domestic applicants copy drugs that have been listed in the country for the original research drug These drugs should be consistent with the quality and efficacy of the reference formulation Category 5: Applications for overseas-listed drugs are listed on the domestic market 5.1 Applications for overseas listing of original research drugs and modified drugs are listed on the domestic market Improved drugs should have obvious clinical advantages 5.2 Applications for generic drugs listed overseas are listed on the domestic market original research drug refers to the first domestic and foreign approved for market, and has complete and adequate safety, effectiveness data as the basis for listing reference formulation refers to the use of generic drugs developed and used by the evaluation and confirmation of the national drug regulatory department The selection and publication of the reference preparationshall shall be implemented in accordance with the relevant regulations of the state drug regulatory department 2 Relevant registration management requirements (i) chemicals 1 as innovative drugs, should contain new structurally clear, pharmacological compounds, and have clinical value, not including improved new drugs in class 2.1 drugs New compound preparations containing new structured compounds with pharmacological effects shall be declared in accordance with the chemical class 1 (ii) Chemical synods are new drugs that are improved and optimized on the basis of known active ingredients, which should have obvious clinical advantages over those before the improvement Known active ingredients refer to the active ingredients of domestic or overseas listed drugs If such drugs meet the requirements of multiple situations at the same time, they shall be stated together at the time of declaration (3) The three types of chemicals produced in China are generic drugs that are not listed on the domestic market, with the same active ingredients, dosage forms, specifications, indications, routes and usage dosages as the reference formulations, and prove that the quality and efficacy are consistent with the reference formulations sufficient research data to justify, specifications and usage may not be consistent with the reference formulation (4) The four types of chemicals produced in China are generic drugs of the original research drugs that have been listed in China, with the same active ingredients, dosage forms, specifications, indications, routes and usage of the reference formulation, and prove that the quality and efficacy are consistent with the reference formulation (5) The five categories of chemicals are listed overseas and apply for domestic listing, including domestic and foreign-produced drugs Among them, chemical stylistic drugs 5.1 for the original research drugs and improved drugs, improved drugs on the basis of known active ingredients to optimize, should have significant clinical advantages than before the improvement, chemicals 5.2 category is generic drugs, should prove to be consistent with the quality and efficacy of reference agents, technical requirements and chemicals 3, 4 categories of the same The overseas production of generic drugs developed simultaneously at home and abroad shall be declared in accordance with the chemical 5.2 category, such as the declaration of clinical trials, and shall not require supporting documents for the listing and sale of drugs (6) the addition of listed drugs to the overseas approved domestic unapproved indications shall be declared in accordance with the drug clinical trials and the application channels for the listing of permits (7) During the review and approval of the drug listing application, the classification and technical requirements of drug registration shall not change due to the approval of the preparations of the same active ingredients for listing both inside and outside China The classification of drug registration is determined at the time of the application for listing 3 The declaration information requirements (1) The applicant who submits a drug clinical trial, a drug market registration and a chemical apitic drug application shall conduct a study in accordance with the relevant technical guidelines published by the state drug regulatory department, and organize and submit the declaration data in accordance with the current version of the M4: General Technical Document (CTD) for the Registration of Human Drugs (CTD) format and project order Items that are not applicable may reasonably be missing, but should be indicated not to apply and justify (2) When the applicant submits an application for registration of a drug in a clinical trial, he or she shall submit an electronic clinical trial database on the basis of CTD Specific requirements such as database format and related documents can be found in the relevant guidelines for the submission of clinical trial data (iii) The Drug Review Center of the National Drug Administration will update CTD documents in a timely manner and publish them on the center's website in accordance with the needs of the drug review process and in the light of the revision of the ICH technical guidelines .