China Enforces Regulation on API Registration Renewal

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

Approved	Registration pathway		Status	Feedback
Before 30/11/2017	Independent technical review	Failed	I	Disapproval
		Passed	A	Approval number
Since 30/11/2017	Step 1: File DMF to CDE		I	DMF filing number
	Step 2: Independent or associated technical review	Failed	I	Disapproval notification
		Passed	A	Approval notification

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

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

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

Notes

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. 

ChemLinked BaiPharm Webinar: China DMF Filing System for APIs, Pharmaceutical Excipients and Packaging Materials