The Shanghai Municipal Medical Products Administration or SMPA has launched a pilot program offering pre-submission service for drug supplementary applications.

Through the program, supplementary applications may enjoy a streamlined review and approval process — promising a swift turnaround within 60 working days.

Here are essential points presented in a Q&A format for your reference:

Application process for pre-submission service

Q: What is the application process for the pilot pre-submission service for drug supplementary applications?

A: Applicants shall complete a pre-submission service intention form and submit it to the SMPA Administrative Service Center.

Once eligibility for the pilot program is confirmed, the form shall be forwarded to the Shanghai Center for Drug Evaluation and Inspection or SCDEI for an initial review.

Applicants who have completed studies on major post-marketing pharmaceutical changes for chemical drugs (including active pharmaceutical ingredients) and compiled necessary documentation will be instructed to submit a pre-submission service application along with an electronic dossier disc.

Applicants who have not completed the above preparation may receive pre-submission guidance as requested.

Upon acceptance of the application, applicants identified as needing pre-submission inspection or testing will have these processes started simultaneously.

A thorough review integrating documentation scrutiny, inspection findings and testing results will be carried out.

Upon approval, applicants may formally submit the supplementary application to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA), which shall complete review and approval within the pilot timeline.

Operational scope of pilot program

Q: What kinds of applicants and supplementary applications are eligible for the pilot pre-submission service?

A: Eligible applicants for the pilot pre-submission service conducted in Shanghai are limited to marketing authorization holders (MAHs) and active pharmaceutical ingredients (APIs) manufacturers registered in Shanghai Municipality.

In the current pilot stage, only major post-marketing pharmaceutical changes for chemical drugs (including APIs) are eligible to apply.

However, the following circumstances are not qualified to apply for the pilot pre-submission service:

• Changes that require clinical studies.
• Changes to the suppliers of APIs, excipients, or pharmaceutical packaging materials, where the post-change product registration status is marked as the capital letter "I".
• Applications for consistency evaluation of the Quality and Efficacy of Generic Drugs.

MAHs' registered locations

Q: How can an MAH apply for the pilot pre-submission service when the MAH and the manufacturer are registered in different provinces or municipalities?

A: The pilot pre-submission service for supplementary applications shall proceed in accordance with the territorial jurisdiction principle of the MAH's registered location.

MAHs registered within Shanghai Municipality shall submit applications to the SMPA.

MAHs registered outside Shanghai — but in one of the other nine pilot regions (Beijing, Tianjin, Hebei, Jiangsu, Zhejiang, Shandong, Guangdong, Chongqing and Sichuan) approved by NMPA — may apply through pre-submission service departments of provincial-level drug regulatory authorities in their registration places.

MAHs registered outside the pilot regions are currently ineligible to apply, even if drug manufacturers are within pilot regions.

Pre-submission guidance

Q: How is pre-guidance provided for the pilot pre-submission service?

A: In the process of change studies, applicants intending to apply for the pre-submission service for drug supplementary applications may submit the pre-submission service intention form to the SMPA Administrative Service Center.

Once the application is recognized as in the scope of the service, the SCDEI shall proactively communicate with the applicant and — if requested — provide pre-submission guidance on the following aspects:

• The direction of study and validation.
• Pre-submission service application procedures.
• Dossier compiling specifications.

In cases where the service is terminated due to substantial defects identified during the pre-submission service process, the SCDEI will provide targeted pre-submission guidance based on the review of existing application documentation to support applicants in further optimizing relevant studies.

Stability study data

Q: How should the stability study data be submitted if the study is still ongoing during the application process for the pre-submission service?

A: The pre-submission service application and the stability study may proceed in parallel. Applicants are not required to submit complete stability study data at the time of the initial submission.

However, the stability study must be completed, and a full application dossier including all relevant stability data must be submitted in disc format to SCDEI within 55 working days from the date of acceptance of the pre-submission service application.

Supplemental stability study data shall be submitted as an attachment to the pharmaceutical research materials.

Pre-submission testing procedures

Q: How to apply for pre-submission testing?

A: SCDEI shall initiate the process by issuing a notification for registration testing to applicants.

• Within one working day of receiving the notification: Applicants shall submit a duplicate of the notification with a sampling application (clearly indicating the entity holding the sample and specific sampling address) to the SMPA Administrative Service Center for pre-submission sampling.
• Within one working day of receiving the receipt of the sampling application: Applicants shall submit the required registration testing documents to the Shanghai Institute for Food and Drug Control (SIFDC) for a preliminary review.
• After sampling is conducted by the drug regulatory authorities: Applicants shall promptly deliver the sampling record sheet, samples for testing, standard substances and other required materials to the SIFDC.

If the preliminary review identifies deficiencies, applicants shall also submit the necessary supplementary documentation together with the aforementioned materials.

Frequency of applying for pre-submission service

Q: May applicants apply only once for the pre-submission service for one specific supplementary application item of one specific variety of products?

A: No. Applicants may apply multiple times.

For instance, if the first pre-submission service is terminated due to substantial defects or defects that impede inspection or testing, applicants may reapply after completing the necessary improvements to the relevant research materials.

However, in accordance with the SMPA announcement aforementioned, the pre-submission inspection and testing shall be provided no more than once within a three-month period for one specific supplementary application item of one specific variety of products.

Must-knows for formal submission after pre-submission service

Q: How should a supplementary application be formally submitted after completing the pre-submission service?

A: Following the completion of the pre-submission service, applicants should check the review result through the "pre-submission service section" of the "applicant portal" at the official of the CDE website.

Once approval, applicants can proceed to formally submit supplementary applications to the CDE of the NMPA as per the standard procedure — "pre-submission service completion" must be indicated.

Attention: It is crucial for applicants to ensure consistency between the formally submitted dossier and the final version submitted during the pre-submission process to the SCDEI — the checksum value (SM3 hash value) shall match for both dossiers.

 

Source: Shanghai Municipal Medical Products Administration

Note: The above content is for reference only; the official Chinese document shall prevail.