The Shanghai Municipal Administration of Medical Products has released detailed procedures for its pilot pre-submission service concerning supplementary applications involving overseas-produced drugs.

This initiative, announced on Dec 29, implements a national policy designed to optimize the review and approval process.

1. Who is eligible

This pilot program is open to domestic agents of overseas-produced drugs who are located within Shanghai's jurisdiction.

It specifically targets chemical drugs, including active pharmaceutical ingredients, that require a supplementary application for major post-market pharmaceutical changes.

The following situations are not eligible for this pilot service:

• Major pharmaceutical changes that require clinical studies.

• Changes in the suppliers of the active pharmaceutical ingredient, excipients, or pharmaceutical packaging materials that result in the changed product's registration status being recorded as "I".

2. Simplified process

The application process is designed to be collaborative and efficient, involving several key stages:

Step 1: Expression of Interest. The domestic agent submits a pre-submission service intention form to the Shanghai Municipal Administration of Medical Products' Administrative Service Center to confirm eligibility.

Step 2: Formal Application. Once eligibility is confirmed and change studies are completed, the applicant submits an electronic application dossier on disc and through the "Applicant Portal" of the National Medical Products Administration's Center for Drug Evaluation.

Step 3: Parallel Stability Studies. The applicant can initiate the pre-submission service before completing full stability studies. The complete stability data must be submitted within 55 working days from the application acceptance date.

Step 4: Document Review and Pre-submission Testing. The Shanghai Center for Drug Evaluation and Inspection reviews the materials. When necessary, pre-submission testing is initiated and carried out by the Shanghai Institute for Food and Drug Control.

Step 5: Comprehensive Filing. After review and testing, the Shanghai Center for Drug Evaluation and Inspection informs the applicant of the filing conclusion. If successful, the applicant can formally submit the supplementary application to the National Medical Products Administration's Center for Drug Evaluation.

3. Service points

Key service points for applicants include:

•Document Receiving Agency: Shanghai Municipal Administration of Medical Products' Administrative Service Center

Location: 1st Floor, Building 3, No 728 Yishan Road, Xuhui district

• Pre-submission Guidance and Filing Agency: Shanghai Center for Drug Evaluation and Inspection

Location: Building 2, No 58 Haiqu Road, Pudong New Area

• Pre-submission Testing Agency: Shanghai Institute for Food and Drug Control

Location: No 1500 Zhangheng Road, Pudong New Area

Source: Shanghai Municipal People's Government