China has been implementing reforms of drug registration review and approval since 2015, including a variety of regulations issued to improve the quality of generic drugs. Under the new regulatory framework, the quality and efficacy consistency evaluation of generics has been put into force, the Abbreviated New Drug Application (ANDA) requirements have beenimproved and harmonized with international standards, and the approval timeline has been expedited. Meanwhile, China CDE and NMPA have issued technical guidelines to support drug companies with generic drug research and development, such as bioequivalence (BE) study guidelines for drugs of different dosage forms.
For an overview of these requirements, we have summarized China generic drugregulations and guidelines in the table below.
|
CATEGORY |
REGULATIONS |
SUMMARY |
|---|---|---|
| General Law & Regulation | Drug Administration Law (2019 No. 31) | Regulatory basis for the development, manufacture, business operation, practical use, supervision, and administration of drug products. https://www.nmpa.gov.cn/xxgk/fgwj/flxzhfg/20190827083801685.html(Chinese) |
| General Law & Regulation | Provisions for Drug Registration (2020, No. 27) | Regulatory requirements for drug development, registration, and surveillance for the purpose of marketing authorization. https://www.nmpa.gov.cn/xxgk/fgwj/bmgzh/20200330180501220.html (Chinese) |
| Registration Dossier Requirements | Registration Classification and Dossier Requirements of Chemical Drugs (2020, No. 44) | Guidance on registration classification and basic dossier requirements for chemical drugs, including generics.https://www.nmpa.gov.cn/yaopin/ypggtg/ypqtgg/20200630180301525.html (Chinese) |
| Registration Dossier Requirements | Guidelines for Acceptance and Review of Chemical Drug Registration(Part II. Registration Class 3, 4, and 5.2) (2020, No. 10) | Dossier requirements for ANDA, standards of dossier format review, requirements for application acceptance and procedure.https://www.cde.org.cn/main/news/viewInfoCommon/6386d7ca5a1515db4259acb1b8f16333 (Chinese) |
| RLD Selection & Determination | ANDA Reference Listed Drug Selection and Determination Procedure (2019, No. 25) | RLD selection principles, application pathways, and determination procedure. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20190328162401710.html (Chinese) |
| RLD Selection & Determination | Application Dossier Requirements for ANDA Reference Listed Drug Selection (2020, No. 32) | Detailed dossier requirements for RLD selection application.https://www.cde.org.cn/main/news/viewInfoCommon/42ed76afd7c115901808048a9dafc71e (Chinese) |
| Bioequivalence Study | Announcement on Implementing Bioequivalence Study Filing for Chemical Drugs (2015, No. 257) | Official announcement on changing the BE study application from registration to filing process, with requirements for the scope of drugs and basic steps of BE study filing.https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20151201214701237.html(Chinese) |
| Bioequivalence Study | Technical Guideline for Chemical Generic DrugIn vivo Bioequivalence Study with Pharmacokinetics Endpoints (2016, No. 61) | Guidance on designing BE study with pharmacokinetics endpoints, data processing principles, and BE study requirements fororal and several non-oral dosage forms, such as transdermal patches, some rectal administration drugs, and nasal administration drugs. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160318210001725.html (Chinese) |
| Bioequivalence Study | Guideline for Exemption of In vivo Bioequivalence Study (2016, No. 87) | Requirements for BE study exemption/waiver based on a Biopharmaceutics Classification System(BCS) and additional considerations for other factors that can affectthe exemption, dossier requirements for regulatory application of exemption, and technical requirements for supporting data. https://www.nmpa.gov.cn/xxgk/ggtg/qtggtg/20160519192001687.html(Chinese) |
| Bioequivalence Study | General Requirements for Size of Bioequivalence Batch of Registration Class 4 and 5.2 Chemical Generic Drugs (Oral Solid Dosage Forms) (August 30th, 2018) | China CDE issued regulatory requirements for the size of BE batch of Class 4 and 5.2 generic drugs for the purpose of quality and efficacy consistency between commercially produced batches and BE batch. https://www.cde.org.cn/main/news/viewInfoCommon/48a099103116a99a5e40007f68a47436 (Chinese) |
| Bioequivalence Study | Guideline for Bioequivalence Study on Orally Inhaled Drug Products (2020, No. 49) | Requirements for CMC and BE studies, including PK-BE study, PD-BE study, and randomized, parallel group comparison study, in the development of orally inhaled generic drug products. https://www.cde.org.cn/main/news/viewInfoCommon/e1fac37cca917e1d9355bb630e440c1a (Chinese) |
| R&D Guidelines | Guideline for Pharmaceutical Development of Chemical Generic Drugs of Transdermal Patches (2020, No. 52) | Requirements for batch formula design, process development, product characterization studies and stability testing of generics of transdermal patches. https://www.cde.org.cn/main/news/viewInfoCommon/4fdc83d15725baf7960c60b965f51fee (Chinese) |
| R&D Guidelines | Guideline for Product Development of Chemical Topical Generic Drugs (2021, No.23) | Requirements for batch formula design, process development, control of API/excipients/packaging materials, generic drug quality studies, stability testing, nonclinical study, and BE study of topical generic drugs.https://www.cde.org.cn/main/news/viewInfoCommon/4e790f4ad1cb21091e5a8bf4a107c535 (Chinese) |
| Quality and Efficacy Consistency Evaluation | Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Injectable Generic Drugs (May 14th, 2020) | Requirements for the quality and efficacy consistency evaluation of chemical injectable generic drugs, including batch formula design, process development, control of API/excipients/packaging materials, control of finished drugs, and stability testing. https://www.nmpa.gov.cn/directory/web/nmpa/xxgk/zhqyj/zhqyjyp/20191015162301280.html (Chinese) |
| Quality and Efficacy Consistency Evaluation | Technical Requirements for Quality and Efficacy Consistency Evaluation of Chemical Injectable Generic Drugs (Special Dosage Forms) (May 14th, 2020) | In addition to the above-mentioned Requirements, here are the requirements of CMC, nonclinical, and clinical studiesespecially for liposomes, intravenous emulsions, microspheres, suspensions, and micellar solutions.https://www.cde.org.cn/zdyz/domesticinfopage?zdyzIdCODE=bd48d9ea178b60d6d100848ca5a87b35 (Chinese) |
For English translations or questions on China’s generic drug regulations or ANDAsubmission, you may message us on: info@accestra.com
For further details on China Generic Drug registration requirements, you may be interested in reading the following article:https://www.accestra.com/china-generic-drug-registration-requirements/
