Recently the China Food and Drug Administration (the “CFDA”) released the Reform of Classified Chemical Drug Registrations (the “Reform”) which had immediate effect. According to the Reform, drug applications will be placed into the five categories listed below, depending on whether the drugs have been marketed domestically or abroad. 

New classifications and detailed clarifications have been summarised as below: 

1. Innovative drugs which have never been marketed within or outside China, including:

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

2. Improved drugs which have never been marketed within or outside China, including:

  • 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. 

3. Drugs which imitate innovative drugs that have not been sold within the territory of China but have been sold outside the territory of China, including:

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

4. Drugs which imitate innovative drugs that have been sold within the territory of China, including:

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

5. Drugs which have been marketed outside China, including:

  • 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. 

According to the Reform, Classifications 1-2 are defined as new drugs and will enjoy a 3-5 year monitoring period, which is actually a market exclusivity period during which no generic drug registration will be approved. Similar to the old classification regime, Classifications 3-4 are defined as generic drugs and Classification 5 is defined as import drug. 

This Reform is mostly focused on the classifications of new domestic drugs and generic drugs and does not make substantial changes to the classification of import drugs. 

Please see the Reform (Chinese only).