On March 4, 2016, the China Food and Drug Administration (CFDA) launched and enacted the Work Plan for Reforming Chemical Drugs Registration Classification System (the New Classification). The new classification redefines generics and new drugs and classifies them into five categories:
- Category I – Innovative New Drugs
Chemical compounds with new and clearly defined structures, pharmacological properties, and apparent clinical value that are not marketed anywhere in the world. 5 year monitoring period.
- Category II – Improved New Drugs
Improved new forms of known chemical entities that have not been marketed anywhere in the world. 3-4 year monitoring period.
- Category III – Generic Drugs
Drugs consistent with the original product in quality and efficacy that are marketed elsewhere, but not yet in China.
- Category IV – Domestic Generic Drugs
Same as above but already marketed in China.
- Category V – Imported Drugs
Drugs that have been marketed in other countries, and seek to be marketed in China. Includes both the originator’s drugs and non-originator’s drugs.
In the past, “new drugs” were defined as drugs that had never been marketed in China, even if they were marketed elsewhere. Now, “new drugs” are either new or improved drugs that have never been marketed anywhere in the world.
These new regulations might spur multinational corporations with innovative drugs to start product development and practice in China earlier than they previously would have. Domestic Chinese companies now face the challenge of demonstrating equivalency in quality and efficacy against the originator’s product, regardless of whether or not it is marketed in China. Because China’s drug approval reform is ongoing, it is important for firms to be up-to-date on Chinese drug policy in order to optimize their market-entry strategies.