It is a critical step for overseas drug applicants to choose a right registration classification for marketing authorization in China. Only after determining the product's registration class, and with knowledge of corresponding fees and application dossier requirements, applicants can get on the right track for registration.
Applicants can also evaluate the product to see if it is qualified for expedited programs for drug marketing approval.1
This article is expected to help you understand how China NMPA classifies chemical drugs. For biological product registration classification, please click here.
You can also sign up at ChemLinked BaiPharm portal and watch our webinar Drug Registration Classification System in China.
Article Contents
Chemical Drug Registration Classification
Administrative Fees
1. Chemical Drug Registration Classification
The Chemical Drug Registration Classification and Application Dossier Requirements2 released by National Medical Products Administration (NMPA) took effect on Oct. 1, 2020. The regulation specified the five registration classes of chemical drugs:
Chemical Drug Registration Classification in China | |
Class 1: Innovative new drugs that do not have marketing authorization in or outside China | Drugs having clearly-structured new molecular entities (NMEs), pharmacological effects, and clinical value. *Not including Class 2.1 improved chemical drugs. |
Class 2: Improved new drugs that do not have authorization in or outside China | Class 2.1: ① Drug products containing optical isomers of known active ingredients via splitting, synthesis or other methods; ② Drug products containing esters formed from known active ingredients; ③ Drug products containing salts (including salts hydrogen bonds or coordination bonds) formed from known active ingredients; ④ Drug products containing the changed acid radical, alkali base or metal elements of known active ingredients of salts; ⑤ Drug products containing the newly-formed non-covalent bond derivatives (such as complex chelate or inclusion compound); All the Class 2.1 drug products shall have distinct clinical advantages. |
Class 2.2: Drug products using new dosage forms (including new drug delivery system), new formulation and manufacturing processes, or new administration routes, and with distinct clinical advantages. | |
Class 2.3: New compound preparations containing known active ingredients and having distinct clinical ingredients. | |
Class 2.4: Drug products containing known active ingredients and having new indications. | |
Class 3: Domestic drug products of the originator drugs which have been granted marketing authorization only outside China | Drug products which are the same with the reference listed drugs (RLDs) in the aspects of active ingredient, dosage form, strength, indication, administration route, usage and dosage, and are proved to be consistent with the RLDs in quality and efficacy. *Drug products can be inconsistent with the RLDs in strength, usage and dosage, if the inconsistency is proved to be reasonable by sufficient research data. |
Class 4: Domestic generic drugs of the originator drugs which have been granted marketing authorization in China | Drug products which are the same with the reference listed drugs (RLDs) in the aspects of active ingredient, dosage form, strength, indication, administration route, usage and dosage, and are proved to be consistent with the RLDs in quality and efficacy. |
Class 5: Imported drug products which have been granted marketing authorization outside China and are applying for marketing authorization in China | Class 5.1: Innovative or improved new drugs that have received marketing authorization outside China. Improved drugs shall have distinct clinical advantages. |
Class 5.2: Generic drugs that have received marketing authorization outside China. | |
*Originator drug: the first drug to receive marketing authorization and having sufficient and complete safety and efficacy data to support its marketing authorization. | |
Notes:
1. Applicants shall determine the chemical drug classification when proposing a marketing authorization application. During the review in China, the drug's classification won't be changed even if other drugs get marketing authorization.
2. New drugs in China refer to innovative or improved new drugs without marketing authorization in or outside China.
Class 1 chemical drugs are innovative new drugs. The emphasis is that the Class 1 drugs have new compounds with clear structures and pharmacological effects.
Class 2 chemical drugs are improved new drugs. They have experienced optimization based on the known active ingredients and enjoy distinct clinical advantages.
The known active ingredients refer to the active ingredients of the drugs which have obtained marketing authorization in or outside China.
Innovative new drugs do not include the Class 2.1 improved new drugs.
3. For compound preparations which have new, clearly-structured and pharmacologically-effective chemical compounds, the preparations shall be registered as Class 1 chemical drugs.
4. Generic drugs shall be the same with the reference listed drugs (RLDs) in the aspects of active ingredient, dosage form, strength, indication, administration route, usage and dosage. Generics shall be proved to be consistent with the RLDs in quality and efficacy.
Generics can be inconsistent with the RLDs in strength, usage and dosage, if the inconsistency is proved reasonable with sufficient research data.
If the originator drug is untraceable or has been withdrawn from the market, NMPA recommends that pharmaceutical companies should not apply for marketing authorization for the generics of the untraceable/withdrawn originator drug.
5. Generics that are in collaborated research in and outside China shall be registered as Class 5.2 chemical drugs.
6. Fees (details at the Administration Fee)3
Chemical Drug Registration Fees | |||
Class 1 or Class 2 chemical drugs | Comply with the fee standards of new drugs | ||
Class 3 or Class 4 chemical drugs | Comply with the fee standards of generic drugs | ||
Class 5 imported chemical drugs | Comply with the fee standards of generic drugs | ||
Clinical trial required | Clinical trial application | 134,400 yuan | |
Marketing approval application after clinical trial | 367,600 yuan | ||
Marketing approval application with self-prepared clinical data | 502,000 yuan | ||
Clinical trial not required | 367,600 yuan | ||
2. Administration Fee
Application Type | Domestic products (RMB) | Imported products (RMB) | |
New drug | Clinical trial | 192,000 | 376,000 |
NDA | 432,000 | 593,900 | |
Generic drug | ANDA without clinical trial | 183,600 | 367,600 |
ANDA with clinical trial | 318,000 | 502,000 | |
Variation request | Technical review not demanded | 9,600 | 9,600 |
Technical review demanded | 99,600 | 283,600 | |
License renewal (every 5 years) | Provincial authority | 227,200 | |
Note: An application fee is for one application for one strength, and another 20% fee shall be charged for each application for an extra strength. | |||
For any questions about drug registration in China, please contact us at contact@chemlinked.com.
