• EnglishEnglish
    • Deutsch Deutsch
    • Italiano Italiano
    • Français Français
    • 日本語 日本語
    • 한국어 한국어

CISEMA - China Zertifizierung, Einkauf und Qualitätssicherung

  • Services
    • NMPA Registration – Medical Devices and IVDs
    • NMPA Registration & DMF – Pharmaceuticals
    • NMPA Registration – Cosmetics
    • NMPA Registration – Health Food
    • CML (China Manufacture Licence) – Pressure vessels
    • CCC (China Compulsory Certification) – Industrial and consumer goods
    • Others
      • Sourcing and Quality Control
      • Logistics and Customs Support
      • Sales Support
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Events
    • Trade Fairs & Conferences
    • Seminars
    • Webinars
  • News & Knowledge
    • Regulatory News
      • Medical Devices and IVDs
      • Cosmetics
      • Pharmaceuticals & DMF
      • CCC
      • Pressure Vessels
    • Whitepapers
    • FAQ – NMPA Registration – Medical Devices and IVDs
    • Newsletter Sign Up
    • Others
      • Publications
      • Online Shop
Contact
  • Home
  • News
  • News
  • Changes during the China drug registration – Working procedures implemented

Changes during the China drug registration – Working procedures implemented

changes during china drug registration
Friday, 09 December 2022 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

Changes during the China drug registration – Working procedures implemented

Changes during the China drug registration shall take certain follow-up actions according to the newly implemented “Working procedures for changes during the drug registration application review (Interim)”. The working procedures were announced by the China Center for Drug Evaluation (CDE) on November 11, 2022, and came into effect immediately.

Scope and basic requirements

During the review of the drug registration application,

  • If there are any major changes that may affect the drug’s safety, efficacy and quality control, the applicant shall withdraw the original application first before preparing for application resubmission, including carrying out further research for supplementary information. This set of working procedures applies to other changes occurred during the technical review of clinical trial applications, registration applications, supplemental applications, overseas re-registration applications, etc. for drugs.
  • The change(s) requested by the applicant or the market authorization holder (MAH) shall not affect the technical review of the originally declared items.
  • Applicants are encouraged to notify the CDE as early as possible upon confirmation of change(s) occurred.

When notifying the CDE about a major change, the applicants shall bear in mind that:

  • The fee paid for the original application is non-refundable.
  • The declaration package submitted for the original application will be destroyed by the CDE and no longer be available for the resubmitted application.

Highlights

Implemented on July 1, 2020, the “Provisions of Drug Registration” addresses the management of changes for drugs in China in separate phases:

  • Changes during clinical trials
  • Changes during application review
  • Changes after obtaining market approval

According to the working procedures, the differences between the three is summarized in the following table:

PhaseDeciding factors
Changes during clinical trialsLevel of impact towards safety
Changes during application reviewMajor or minor changes
Changes after market approvalLevel of impact towards safety, efficacy and quality control

Changes during clinical trials

  • If there is a significant safety issue, a supplemental application for change(s) shall suffice.
  • If there is no impact towards safety, submission of a development safety update report (DSUR) during development shall suffice.

Changes during application review

  • For major changes that may affect the drug’s safety, efficacy and quality control, the MAH or applicant will need to withdraw the original application, and resubmit the application in the form of an official document, otherwise, a supplemental application shall suffice with the CDE’s confirmation for minor changes.
  • For applicant information updates, the MAH or applicant shall notify the CDE as early as possible and submit the updated information together.

Changes after market approval

  • The MAH should refer to the separate “Provisions for Change Management of Post-approval Drugs (Interim)” for the implementation details that came into effect on January 12, 2021.
  • For major changes, the MAH shall submit a supplemental application to the CDE.
  • For medium changes, the MAH shall report to the CDA or provincial medical products administration (MPA) for filing the record.
  • For minor changes, the MAH should address the management of changes in the annual report.

Further information

Click here to read the announcement on “Working procedures for changes during the drug registration application review (Interim)” in full.

Click here to read the “Provisions of Drug Registration”.

A separate work procedures update was also issued on November 16, 2022, by CDE called Administrative Rules on Stopping and Resuming the Time Clock for Drug Review. It makes clear that the relevant time periods for application review is paused when CDE asks applicants to submit supplemental documents. The clock will continue when the required documents are submitted to CDE.

If you would like to learn more about our registration and CRO services for pharmaceuticals, medical devices, IVDs, cosmetics, health foods, industrial or consumer goods please contact Cisema.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers
📣 Sign up for our newsletter

What you can read next

Overseas New Drugs Urgently Needed
Update of Administrative Measures for the Clinical Use of Medical Devices
Some Medical Devices Exempted from Clinical Trials

Search

Categories

  • Fairs & Events
  • News
    • CCC
    • CEL
    • CML, SELO
    • Medical Devices Listing in Hong Kong
    • NMPA Registration in China
      • Cosmetics
      • Health Food
      • Medical Device
      • Pharmaceuticals & DMF
    • RoHS
    • Voluntary Product Certification
  • Publications
  • Seminars
  • Uncategorized
  • Webinars

Recent Posts

  • China cosmetics efficacy claims FAQ

    China cosmetics efficacy claims FAQ available to answer key questions

    China cosmetics efficacy claims FAQ is availabl...
  • China cosmetics GMP inspections

    China cosmetics GMP inspections points have been finalised

    China cosmetics GMP inspections points and judg...
  • China medical device quality safety responsibility

    China medical device quality and safety responsibility regulations come into force on March 1, 2023

    China medical device quality and safety respons...
  • China drug standards draft measures

    China drug standards draft measures have been published by the NMPA

    China drug standards draft measures have recent...
  • China special equipment safety supervision

    China special equipment safety supervision – draft provisions released

    China special equipment safety supervision regu...

Archive

Cisema

With twelve locations and over ninety highly qualified employees, Cisema can offer you optimal support in China.

Services

  • Certification
  • Sourcing and Quality Control
  • Logistics and Customs Support
  • Sales Support

Dialogue

  • Contact us
  • Newsletter Signup
  • Events
  • News & Knowledge
  • Partners

Company

  • GTC
  • Privacy Statement
  • Legal Notice
  • About us
  • Locations
  • GET SOCIAL

© 2021 Cisema. All rights reserved.

TOP
Cookies on Cisema
Learn more about Cisema's Privacy Policy.