Background: The Change of API Approval Process in 2017
To understand how China regulates active pharmaceutical ingredient (API) registration renewal, it’s necessary to know how APIs get registration approval in the first place.
Before Nov. 30, 2017, API manufacturers were required to register APIs independently. The approved APIs got approval numbers, which are valid for five years from the approval dates.
As the drug master file (DMF) system extended to APIs on Nov. 30, 2017, API manufacturers shall first file DMFs on the Center for Drug Evaluation (CDE)’s online platform. Each filed API has a DMF filing number.
The on-file APIs shall undergo either of the two reviews below to get approval notifications, which is valid for five years from the approval date.
1) Technical review separated from other products, or
2) Associated technical review together with excipients, packaging materials, and finished dosage forms (FDFs).
Each approved API’s filing status will be marked with “A” while the unapproved ones are marked with “I”. Those approved before Nov. 30, 2017 were also marked “A” after their information were transferred to CDE’s DMF online filing platform.
Table 1: API Registration Pathway in China
Independent technical review
Step 1: File DMF to CDE
DMF filing number
Step 2: Independent or associated technical review
On October 13, 2023, China National Medical Products Administration (NMPA) implemented the Notice on the Administration of Chemical API Registration Renewal (hereafter referred to as the Notice).
Registration renewal applies to APIs that have obtained approval number or approval notification.
1. Applicants and Competent Authorities
The submission and processing the renewal applications depend on the location of the manufacturing site, which are described in Table 2.
Table 2: Entities for submitting API registration renewal applications and competent authorities for processing the applications
Manufactured in China
local provincial-level medical products administration
Manufactured outside China
Corporate entity that is appointed by the foreign manufacturer as its local agent in China
2. Timing for Submitting Renewal Application
NMPA designates a 1-year transition period from Oct. 13, 2023 when the Notice takes effect. The timing requirements for submitting the renewal application during the period are listed in Table 3.
Table 3: Timing requirements for submitting API registration renewal application in China
The left validity period of the original approval document by 13/10/2023
The timing to submit renewal application
API with approval number
≥ 6 months
At least 6 months before the original approval number expires
< 6 months
Within 1 year from 13/10/2023
API with approval notification
≥ 6 months
At least 6 months before the original approval notification expires
< 6 months
Within 1 year from the approval notification’s issuance
After the transition period, all manufacturers of approved APIs shall apply for registration renewal more than 6 months before the expiration of the approval number/notification.
3. Results of API Registration Renewal Application
The provincial-level medical products administration or CDE will review the renewal application. CDE will mark the API’s status and decide whether to issue the renewal approval notification.
Table 4: Review and approval of API registration renewal application
Review for renewal
Renewal approval notification
Renewal application submitted in time
Renewal application not submitted in time
Post-approval change applications are NOT allowed to be submitted together with the API registration renewal application, because the two types of applications are handled by separate authorities with different review timeframes.
Contact BaiPharm if you’d like to register API or renew your registration.