NMPA Supplementary


2022-03-08

1. Definition of Supplementary

When the registration information can not meet relevant requirement or need additional information during evaluation, reviewers will issue a “Deficiency Letter” to the applicant collectively requesting the information needed at one time.

2. Way of Supplementary

(1). Online Mode

Issue the “Deficiency Letter” to the applicant/registrant through the eRPS system, mail the print edition of the “Deficiency Letter” at the same time.

(2). Offline Mode

Mail the printed “Deficiency Letter” to the applicant/registrant.

3. Requirement of Supplementary

Applicant/Registrant should complete the submission of the supplementary information within one year, according to the “Deficiency Letter” strictly.

4. Delivery

(1). Online Mode

Applicant/Registrant can submit the supplementary documents through “supplementary” module in eRPS system.

(2). Offline Mode

Applicant/Registrant can send supplementary documents by delivery or post. Importantly, the supplementary documents submitted offline should include both paper and electronic versions, and the two documents are consistent. The electronic supplementary documents will be imbedded into RPS ToC.

Office hour: Monday to Friday (excluding Thursday) 9:00am-11:00am 13:30pm-16:00pm.

Address: Building No. 1, Courtyard No. 50, Qixiang Road, Haidian District, Beijing.

Department for Receiving: Deficiency Team of the Department of General Affairs Tel: 010-86452929.

5. TIPS

For the online submission of the eRPS, the electronic documents should meet the relevant requirements.

Content description, table of contents and details of supplementary content shall be attached to the deficiencies according to the sequence required by the Deficiency Letter.

The time of preparation for deficiencies will not be included in review timeframe.

In case of any doubts about the content of the Deficiency Letter, the applicant may consult the relevant reviewer. See details in the “Consultation after Supplementary”.

The pre-evaluation process for supplementary documents is a consulting method. It will be submitted to the corresponding reviewers, and a written feedback will be send to applicant/registrant.