I. Registration Classification of Chemical Drugs
The registration classification of chemical drugs includes innovative drugs, modified new drugs, generic drugs, and chemical drugs overseas marketed but not domestically marketed, please refer to the following 5 classifications:
Classification 1: Innovative drugs that are not marketed overseas and domestically. It refers to a clinically valuable drug containing a new compound which has a well-established structure and pharmacologically activity.
Classification 2: Modified new drugs that are not marketed overseas or domestically. It refers to a drug that has obvious clinical advantages by optimizing its structure, dosage form, formulation and manufacture process, route of administration, indication(s), etc. on the basis of known active ingredient(s).
2.1 A new drug that contains an optical isomer of a known active ingredient by resolution or synthesis or etc., an ester or a salt (including a salt containing a hydrogen bond or coordination bond) of a known active ingredient, an alternative salt with change of acid radical/base/metal element to a known active ingredient, or other non-covalently bonded derivatives (e.g., complexes, chelates, or clathrates) of a known active ingredient, which has obvious clinical advantages.
2.2 A new drug with new dosage form (including new drug delivery systems), new formulation and manufacture process, new route of administration, which contains a known active ingredient and has obvious clinical advantages.
2.3 A New combination drug containing a known active ingredient, which has obvious clinical advantages.
2.4 A drug for new indications, which contains a known active ingredient.
Classification 3: Generic drugs applied by domestic applicant, with an innovative drug that has been marketed overseas but not marketed domestically. Such drugs should be consistent with the quality and efficacy of the reference listed drug (RLD).
Classification 4: Generic drugs applied by domestic applicant, with an innovative drug that has been marketed domestically. Such drugs should be consistent with the quality and efficacy of the RLD.
Classification 5: Domestic applications for drugs overseas marketed.
5.1 Domestic application for an innovative drug or a modified drug that has been marketed overseas. The modified drug should have obvious clinical advantages.
5.2 Domestic application for a generic drug that has been marketed overseas.
The innovative drug refers to the first drug approved for marketing domestically and overseas, which has complete and sufficient safety and efficacy data as the basis for marketing.
A RLD refers to a reference drug used in the development of a generic drug that has been evaluated and confirmed by the national drug regulatory authorities. The selection and publication of the RLD are in accordance with the relevant provisions of the national drug regulatory authorities.
II. Relevant Registration Management Requirements
(1) Chemical drug Classification 1 refers to a clinically valuable drug containing a new compound which has a well-established structure and pharmacologically activity, excluding Classification 2.1 in modified new drugs. New combination drugs containing new well-established structure and pharmacologically active compounds should be submitted in accordance with chemical drug Classification 1.
(2) Chemical drug Classification 2 refers to new modified drugs which has been modified on the basis of known active ingredient(s) and should have obvious clinical advantages after modification. The known active ingredient refers to the active ingredient of a domestically or overseas marketed drug. If the drugs are consistent with more than one requirement above, it should be explained at the time of application.
(3) Chemical drug Classification 3 refers to generic drugs manufactured domestically with an innovative drug that has been marketed overseas but not marketed domestically, which has the same active ingredients, dosage forms, strengths, indications, routes of administration and dosage and administration as the RLD, and has been demonstrated that the quality and efficacy are consistent with the RLD.
Strengths and dosage and administration may be inconsistent with the RLD when adequate study data are available to justify.
(4) Chemical drug Classification 4 refers to generic drugs manufactured domestically with an innovative drug that has been marketed domestically, which has the same active ingredients, dosage forms, strengths, indications, routes of administration and dosage and administration as the RLD, and has been demonstrated that the quality and efficacy are consistent with the RLD.
(5) Chemical drug Classification 5 refers to domestic applications for drugs overseas marketed, including drugs manufactured domestically and overseas. Chemical drug Classification 5.1 refers to innovative drugs and modified drugs. Modified drugs should be optimized on the basis of known active ingredient(s) and should have obvious clinical advantages after modification; Chemical drug Classification 5.2 refers to generic drugs, and it should demonstrate that the quality and efficacy are consistent with the RLD, technical requirements are same as chemical drug Classification 3 and 4. For generic drugs synchronously developed domestically and overseas and manufactured overseas, the application should be submitted in accordance with chemical drug Classification 5.2, for the clinical trials application, no marketing approval supporting documents are required.
(6) For drugs that have been marketed, a new indication that has been approved overseas but not domestically should be submitted in accordance with the channel of drug clinical trial application and new drug application.
(7) In the process of the review and approval of a new drug application, the drug registration classification and technical requirements will not change due to the approval overseas and domestically of a drug with the same active ingredient. The drug registration classification is determined at the submission of new drug application.
III. Requirements for Submission Dossiers
(1) The applicant should conduct the study in accordance with the relevant requirements of the relevant technical guidelines issued by the national drug regulatory authorities when submitting drug clinical trials application, new drug application and chemical drug substance application. The application dossier should be prepared and submitted according to the formatting numbering and item order of the current version"M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use" (hereinafter referred to as CTD). N/A items may be reasonably omitted, but N/A should be indicated and justified.
(2) When the applicant completes the clinical trial and submits a new drug application, the electronic clinical trial database should be submitted on the basis of CTD. Specific requirements such as database format and relevant documents can be found in relevant guidelines for clinical trial data submission.
(3) The Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA) will update the CTD documents timely and publish on the CDE website in accordance with the requirements of drug review and in conjunction with the revision of the ICH technical guidelines.
