China NMPA Consults on Chemical API Registration Renewal Regulation

by Grace Wang Nov 09, 2022

Background: The Change of API Approval Process in 2017

To understand the active pharmaceutical ingredient (API) registration renewal, it's necessary to know how APIs get registration approval in the first place.

Before Nov. 30, 2017, APIs manufacturers were required to register APIs. The approved APIs were granted with approval numbers, which are valid for five years from the approval dates.1

As the DMF (drug master file) system extended to APIs since Nov. 30, 2017, API manufacturers shall first file DMFs on the Center for Drug Evaluation (CDE)'s online platform. All the previously approved APIs have been transferred to the online filing platform. Each filed API has a filing number.

The on-file APIs shall go through the below two reviews to get the approval notification, 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

Each approved API's filing status will be marked with "A" while the unapproved ones are marked with "I".

Approval Time

API Approval Process

Filing Status

Approval Document

Before Nov. 30, 2017

Registration based on the independent technical review

A

Approval number

Since Nov. 30, 2017

Step 1: Filing DMF to get a filing number;

I

-

Step 2: Registration based on the independent/associated technical review

A

Approval notification


On Nov. 4, China National Medical Products Administration (NMPA) released the draft of Announcement on the Administration of Chemical API Registration Renewal (hereafter referred to as the Announcement).2

Requirements for API Registration Renewal Application

NMPA designates a 1-year transition period from the date when the Announcement takes effect. The timing requirements for submitting the renewal application during the period are shown in the table below:

API Registration Renewal Requirements During the 1-year Transition Period

API

The left validity period of the original approval document

The timing to submit renewal application

API with approval number

More than 6 months when the Announcement   takes effect

At least 6 months before the original approval number expires

Less than 6 months when the Announcement takes effect

Within 1 year from the Announcement's implementation date

None when the Announcement takes effect

API with approval notification

More than 6 months when the Announcement takes effect

At least 6 months before the original approval notification expires

Less than 6 months when the Announcement takes effect

Within 1 year from the approval notification's issuance date

None when the Announcement takes effect

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.

Competent authorities:

For APIs manufactured in China, filers shall apply for renewal from the local provincial-level medical products administrations. For APIs manufactured overseas, filers shall submit the renewal application to CDE.

Results of API Registration Renewal Application

The provincial-level medical products administration (MPA) or CDE will review the renewal application, mark the API's filing status, and decide whether to issue the renewal approval notification.

Review and Approval of API Registration Renewal Application

API

Review for renewal

Filing status

Renewal approval notification

Renewal application submitted in time

Passed

A

Granted

Failed

I

Not granted

In process

In process

Not granted

Renewal application not submitted in time

N/A

I

Not granted

For API that fails the renewal review, NMPA will mandate the cancellation of the corresponding filing number.

Mandatory Cancellation of API Filing Number

API

Disapproval of the renewal application

Cancellation of the filing number

Manufactured in China

By   local provincial-level medical products administration

By NMPA

Manufactured overseas

By CDE

By NMPA

Voluntary Cancellation of API Filing Number

API filers can apply for canceling the filing number voluntarily.

Voluntary Cancellation of API Filing Number

API

Competent Authority

Manufactured in China

Local provincial-level medical products administration

Manufactured overseas

CDE

BaiPharm's Comment

China is a hub for chemical API production and sales. In 2021, China produced 3,086,000 tons of APIs, up by 12.87% year on year. The total revenue reached 426.5 billion yuan (circa 59 billion USD), a yearly growth of 8.1%.3

The Announcement can help regulate such an API production hub by strengthening the API manufacturer as a main responsibility entity for registration renewal. Manufacturers of approved APIs should pay special attention to the renewal application requirements so that their APIs can keep a valid filing number and approval document.

Any public comments and advice on the Announcement can be sent to hxypc@nmpa.gov.cn before Dec. 3, 2022. Any enquiries about API filing and registration are welcomed for professional answers and solutions from BaiPharm.

webinar-china-dmf-filing-system-for-apis-pharmaceutical-excipients-and-packaging-materials.pngChemLinked BaiPharm Webinar: China DMF Filing System for APIs, Pharmaceutical Excipients and Packaging Materials

Grace Wang
ChemLinked Regulatory Analyst
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