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.
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 without marketing authorization in or outside China | Drugs having a clearly-structured new molecular entity (NME), pharmacological effects and clinical value. A new compound drug having a clearly-structured NME and pharmacological effects. *Not including Class 2.1 of improved chemical drugs. |
Class 2: Improved new drugs without marketing authorization in or outside China | Class 2.1: ①Drug products containing optical isomers of known active ingredients formed from splitting, synthesis or other methods; ②Drug products containing esters formed from known active ingredients; ③Drug products containing salts (including salts hydrogen bonds or coordination bonds) formed from known active ingredients; ④Drug products containing the changed acid radical, alkali base or metal elements of known active ingredients of salts; ⑤Drug products containing other newly-formed non-covalent bond derivatives (such as complex, chelate or inclusion compound); All Class 2.1 drug products shall have distinct clinical advantages. |
Class 2.2: Drug products with known active ingredients and using new dosage forms (including new drug delivery system), new prescription processes, or new administration routes. All Class 2.2 drug products shall have 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 generic drug products whose original version 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 drug products whose original version 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 granted marketing authorization outside China and 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. | |
*Original drug: the first drug that received marketing authorization supported by sufficient and complete safety and efficacy data. | |
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 gained marketing authorization in or outside China.
Innovative new drugs do not include the Class 2.1 of 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 original version of the approved drug is untraceable or has been withdrawn from the market, NMPA recommended that pharmaceutical companies should not apply for marketing authorization for the generics of the untraceable/withdrawn original 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 and Class 2 chemical drugs | Comply with the fee standards of new drugs | ||
Class 3 and 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 required | 9,600 | 9,600 |
Technical review required | 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, welcome to contact us by sending an email to contact@chemlinked.com.
