On January 17, 2020, The Center of Drug Evaluation (CDE) published a “Notice on improving the relevant functions of the API registration system.” The CDE announced the newly improved API registration system, which has updated the API registration form and related administrative licensing documents. The API enterprise in accordance with the requirements of the existing regulations, submit a separate review and approval through the registration system, for API already used in China listed pharmaceutical preparations.
CDE API Classifications:
CDE classifies API into two categories:
Category I is the API which has already been used in listed final drug product in China, whether in domestic generics or importation drug. This category can be reviewed separately before final drug preparation product. Applicant needs to provide the information of drug preparation listed in China including brand name, specification, dosage form, licensee, registration number, validation date,etc..
Category II is for API has not been used in China in any forms. This category has to be reviewed with final drug preparation. In this case, the timeline would be delayed than format review days CDE regulated in No.146. CDE has suggested in Notice on matters relating to the declaration of chemical raw materials, 01/13/2020, final drug preparation applicant can file drug registration application with the DMF dossier in a complete final package to accelerate the process.
Important New Provisions:
In the new regulation, more information is required from applicant.
1.API applicants need to provide final drug registration classification, whether the API would be used in:
- 1) Novel drug which has not been listed in any countries,
- 2) Category 2.1 new drug OR
- 3) Drug approved in other countries but not China yet.
2. The applicant also needs to provide registration purpose, whether it is for clinical study or commercialization.
3. The origin and registration number of packaging material. Fourthly, the product Chinese name, which should be officially promulgated the National Drug Standards or the National Pharmacopeia Commission’s General Name of Chinese Medicines.
Notice on improving the relevant functions of the API registration system (chinese)
- Notice on matters relating to the declaration of chemical raw materials, 01/13/2020( chinese)