• 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
  • New drug clinical trial applications 2020 annual report issued

New drug clinical trial applications 2020 annual report issued

Monday, 20 December 2021 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

New drug clinical trial applications 2020 annual report issued

New drug clinical trial applications 2020 annual report was published on November 10, 2021, by the China CDE (Center for Drug Evaluation). The online drug platform received a total of 2602 clinical trial applications in 2020 with an increase of 9.1% as compared to 2019.

According to the new drug clinical trial applications 2020 annual report, 1473 applications were for new drugs and 1129 applications were for generic drugs. Under the new drug category, 801 applications (73.6%) were for chemical drugs, 605 applications (23.8%) were for biological products, and 67 applications (4.5%) were chinese medicine and natural drug products.

Although the report points out problem such as homogenization in drug clinical trials, inefficient implementation of clinical trials after approvals, etc., there is still an increasing demand of clinical trial applications for drugs in China.

Further information

Read the original CDE report on new drug clinical trial applications in 2020.

In China, drugs are divided into TCM (Traditional Chinese Medicine), chemical drugs, and biological products for classified management.

As part of the registration of pharmaceuticals, manufacturers must also submit the DMF (Drug Master File) number of the pharmaceutical packaging and ingredients. Cisema can support the applicant during the preparation of the supplementary dossier and the second NMPA technical evaluation.

If you would like to learn more about pre-market registration or post market surveillance for pharmaceutical products in China, contact Cisema.

GET IN TOUCH

🌐 Send us your enquiry
📚 Request our whitepapers
📣 Sign up for our newsletter
Tagged under: chemical drugs, drug clinical trial, drugs, new drugs

What you can read next

drug-device
Technical Review Guidelines Finalized for Medical Device-Based Combination Products
Registration of disposable infusion devices in China
Registration of disposable infusion devices in China – Amended guidelines issued
Guidelines for Sampling Testing on Organic Foods

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