Circular of the General Administration of the people's Republic of China on the issuance of the work plan for the reform of the registration and classification of chemical drugs (2016 No. 51)

Source: CFDA 2016-3-7 according to November 4, 2015 Decision on Authorizing the State Council to carry out pilot drug listing license holder system in some places and related issues, adopted at the 17th meeting of the Standing Committee of the 12th National People's Congress on May 12, 2010 The State Food and drug administration has formulated a reform plan for the registration and classification of chemical drugs, which has been approved by the State Council, and is hereby announced and issued by the State Council Implemented from the date of deployment Annex: the work plan for the reform of chemical registration and classification the work plan for the reform of chemical registration and classification of the General Administration of food and Drug Administration of the people's Republic of China on March 4, 2016 is formulated to encourage the creation of new drugs, strictly review and approve, improve the quality of drugs, promote industrial upgrading, and reform the current chemical registration and classification I adjust the chemical drug registration classification and adjust the chemical drug registration classification The new chemical registration classification is divided into five categories, as follows: 1 Innovative drugs that are not listed at home and abroad It refers to a new drug with clear structure, pharmacological effect and clinical value Class 2: improved new drugs not listed at home and abroad It refers to the drugs with obvious clinical advantages, which optimize the structure, dosage form, prescription process, route of administration, indications, etc on the basis of known active ingredients Category 3: the domestic applicant imitates the drugs listed overseas but not listed in China This kind of drugs should be consistent with the quality and efficacy of the original drugs The original research drug refers to the first drug approved for listing at home and abroad, and has complete and sufficient safety and effectiveness data as the basis for listing Category 4: the domestic applicant imitates the drugs that have been listed in the domestic market This kind of drugs should be consistent with the quality and efficacy of the original drugs Category 5: overseas listed drugs apply for listing in China Table 1 new registration classification, description and situation registration classification description of chemical drugs case 1 innovative drugs that are not listed at home and abroad contain new APIs and their preparations with clear structure, pharmacological effect and clinical value 2 Improved new drugs not listed at home and abroad 2.1 An optical isomer containing a known active ingredient, or an ester of a known active ingredient, or a salt (including a salt containing a hydrogen bond or a coordination bond) of a known active ingredient, or an acid radical, base or metal element that alters the active ingredient of a known salt, or forms other non covalent bond derivatives (such as complexes, chelates or inclusions ）, and has obvious clinical advantages of APIs and their preparations 2.2 a new dosage form (including a new drug delivery system), a new prescription process and a new drug delivery route with known active ingredients, and a preparation with obvious clinical advantages 2.3 the new compound preparation with known active ingredients has obvious clinical advantages 2.4 preparations with new indications containing known active ingredients 3 The drugs that are imitated from the original drugs that are listed abroad but not listed in China have the same active ingredients, dosage forms, specifications, indications, routes of administration, usage and dosage as the original drugs and their preparations 4 The drugs that have been imitated and marketed in China have the same active ingredients, dosage forms, specifications, indications, routes of administration, usage and dosage as the original drugs and their preparations 5 Application for listing in China of drugs listed abroad 5.1 application for listing in China of original research drugs (including APIs and their preparations) listed abroad 5.2 non original research drugs (including APIs and their preparations) listed overseas shall apply for listing in China Note: 1 "Known active ingredients" refers to "active ingredients of marketed drugs" 2 Registration classification 2.3 does not include "new compound preparations containing unknown active ingredients" 2 Relevant registration management requirements (1) review and approval of new drugs, emphasizing the requirements of clinical value on the basis of material basis originality and novelty, among which the requirements of improved new drugs have obvious clinical advantages over those before improvement The evaluation and approval of generic drugs should be consistent with the quality and efficacy of the original drugs (2) the new registered drugs of categories 1 and 2 shall be declared in accordance with the procedures for new drugs in the measures for the administration of drug registration; the new registered drugs of categories 3 and 4 shall be declared in accordance with the procedures for generic drugs in the measures for the administration of drug registration; the new registered drugs of categories 5 shall be declared in accordance with the procedures for imported drugs in the measures for the administration of drug registration If the newly registered drugs of category 2 meet the requirements of multiple situations at the same time, they shall be listed in the application form (3) according to the relevant requirements of the regulations for the implementation of the drug administration law of the people's Republic of China, a 3-5-year monitoring period shall be established for new drugs as follows: Table 2 monitoring period of new chemical drugs table registration classification monitoring period 15 years 2.13 years 2.24 years 2.34 years 2.43 years (4) the chemical drug registration applications accepted before the issuance and implementation of this plan may continue to be reviewed and approved in accordance with the original provisions, or may apply for review and approval in accordance with the new registration classification If the application is reviewed and approved according to the new registration classification, the technical data will not be supplemented after the relevant fees are paid, the drug review center of the State Food and drug administration shall set up a green channel to speed up the review and approval If it meets the requirements, it shall be approved for listing; if it does not meet the requirements, it shall not require any additional information and shall not be approved directly (5) the drug approval number (import drug registration certificate / medical product registration certificate) issued by the registration application of the new registration classification has the same effect as the drug approval number (import drug registration certificate / medical product registration certificate) issued by the registration application of the original registration classification (6) the State Food and drug administration shall organize relevant departments to refine work requirements, and do a good job in acceptance, inspection, technical review, formulation and revision of relevant national drug standards (7) in case of any inconsistency between the measures for the administration of drug registration and the plan, the requirements of the plan shall be followed.