• 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
  • 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
  • About us
    • Partners
    • Company Profile
    • Testimonials
  • Locations
  • Newsletter Sign Up
Contact
  • Home
  • News
  • News
  • Clinical Trials GMP Management Specification for Drugs – Appendix (Draft) Issued

Clinical Trials GMP Management Specification for Drugs – Appendix (Draft) Issued

Clinical Trials GMP management
Saturday, 26 February 2022 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

Clinical Trials GMP Management Specification for Drugs – Appendix (Draft) Issued

Clinical trials GMP management specification first issued its draft in July 2018 aiming to help prepare drugs for clinical trials (including test drugs and placebo), and for changes in packaging and labeling for already marketed drugs as comparator and test drugs.

On January 18, 2022, the NMPA (National Medical Products Administration) issued the new appendix (draft) of the GMP (Good Manufacturing Practice) for drugs for clinical trials.

Key changes to previous clinical trials GMP management specification

  • Implementation of clinical batch release.
  • Applicant should establish a filing system by product category.
  • Standardize the changes in management during the clinical period.
  • Keep the intra- and inter-batch consistent for clinical trial drugs.
  • Clinical trial drugs require the risk assessment of collinearity and cleaning validation.
  • A complete sample retention management system for drugs used in clinical trials.

By Yu Fang and Jacky Li. Contact Cisema if you would like to learn more.

Tagged under: Clinical Trials, drug clinical trial, GMP, Good Manufacturing Practice, pharmaceuticals

What you can read next

Standard GB 15742 Revision 2019 Implementation as of January 1st, 2020
Clinical trials of sodium hyaluronate complex solution
Clinical trials of sodium hyaluronate complex solution – draft guidelines issued
Regulatory Measures for Self-testing
China Regulatory Measures for Self-testing Finalized

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

  • laser therapy devices

    Clinical evaluation of laser therapy devices – New guidelines issued

    Clinical evaluation of laser therapy devices ha...
  • dental implant system

    Clinical evaluation of dental implant systems in China – New guidelines issued

    Clinical evaluation of dental implant system ha...
  • China Medical Device Webinar

    China Medical Device Webinar with AdvaMed Accel for U.S. exporters

    The China Medical Device Webinar will be featur...
  • webinar_medical-device-market-authorisation

    Cisema presenting at FORUM Institut: Medical device marketing authorisation for advanced – Masterclass China

    Cisema is delighted to hold a Masterclass with ...
  • generative AI services

    China’s generative AI interim measures now in effect

    China’s generative AI interim measures fo...

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