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China new classification system for chemical drug CFDA registration ( 2016 version)

On March 4, 2016, China Food and Drug Administration (CFDA) issued a new regulation - ¡°the Work Plan for Reforming Chemical Drugs Registration Classification System ¡°;

The New Classification System (2016 version) changed the previous chemical drug classification system (2007 version) and sets forth new registration requirements for applicants.

Under the New Classification System, chemical drugs are classified into 5 categories, Below is an overview of the new classification system:

Classification Definition / Scope Monitoring period

Class 1: Innovative new drugs which have never been marketed within or outside China,

Active ingredients and their formulations which have clinical value and contain compounds with new structures and pharmacological effects.

5 years

Class 2: Improved new drugs which have never been marketed within or outside China

2.1 - Drug substances or preparations which contain optical isomers of the known active ingredients by using the splitting or the synthesis method; turn known active ingredients into ester or salt (including salt containing hydrogen bonds or coordination bonds); change the acid radical, alkali base or metal element of the known active ingredients of salts; or turn into other non-covalent bond derivatives (such as complex chelate or inclusion compound), which also have an obvious clinical advantage.
2.2 - New drug preparations using the new dosage form (including the new drug delivery system); the new prescription process or the administration route for known active ingredients, and with an obvious clinical advantage.
2.3 - New compound preparations of known active ingredients, which also have an obvious clinical advantage.
2.4 - New preparations of known active ingredients with new indications.

2.1- 3 years
2.2- 4 years
2.3- 4 years
2.4- 3 years

Class 3: Domestic Drugs which imitate innovative drugs that have not been marketed within China but have been marketed outside of China

Drug substances or preparations that have the same active ingredients, dosage forms, strengths, indication, administration route, usage and dosage as innovative drugs.

0 year

Class 4: Domestic Drugs which imitate innovative drugs that have been marketed within China

Drug substances or preparations that have the same active ingredients, dosage forms, strengths, indication, administration route, usage and dosage as innovative drugs.

0 year

Class 5: Imported Drugs which have been marketed outside China, apply china domestic market approval.

5.1 - Innovative drugs (including drug substances or preparations) that that have been approved outside China.
5.2 - Non-innovative drugs (including drug substances or preparations) that that have been approved outside China.

0 year

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