• 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
  • NMPA Registration in China
  • Pharmaceuticals & DMF
  • Approval of Clinically Urgent New Drugs

Approval of Clinically Urgent New Drugs

Monday, 10 December 2018 / Published in Pharmaceuticals & DMF

Approval of Clinically Urgent New Drugs

On 30.10.2018, the NMPA (former NMPA) issued guidelines for the approval process of clinically urgent new drugs (NMPA No. 79-2018). The product range, selection criteria, review procedure, and requirements for the application documents were specified.

Tagged under: drugs, pharmaceuticals

What you can read next

Public Consultation on the Measures of Review Management on Advertising for Health Food, FSMP, Drug Products and Medical Devices
ICH E8 (R1)
ICH E8 (R1) General Considerations for Clinical Studies have been approved in China
CDE announces Latest Consultation Arrangements

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.