• 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
  • CDE announces Latest Consultation Arrangements

CDE announces Latest Consultation Arrangements

Tuesday, 25 January 2022 / Published in News, NMPA Registration in China, Pharmaceuticals & DMF

CDE announces Latest Consultation Arrangements

Considering the current requirements for epidemic prevention and control and the need of innovative drug developments in China, the CDE (Center for Drug evaluation) of the NMPA (National Medical Products Administration) made an announcement on December 22, 2021, listing out the consultation arrangements with enhanced support of technical guidance and services provided to the applicants:

Inquiries related to key stages of drug development

According to the Administrative Measures for Communication and Exchange of Drug Development and Technical Review (No. 48-2020), applicants can apply for a video conference meetings for inquiries related to key stages of drug development. If a video conference meeting is considered not required by the authorities, a timely response will be written back to the applicant.

General inquiries

Applicants are recommended to utilize the online platform to make general inquiries. The CDE classifies inquiries as technical or non-technical. Technical questions will be answered within 15 working days, and non-technical questions will be answered within 10 working days.

Real-time consultation on matters related to registration applications

According to the requirements of epidemic prevention and control, CDE has adjusted the on-site consultation every Wednesday to telephone consultation. Applicants can call for real-time consultation. Every Monday, Wednesday and Friday, call 010-85243528 for review business consultation; Tuesday and Thursday, dial 010-85242306 for consultation about registrations.

Consultation on product management review

Applicants can contact the project manager by phone, and the contact information could be found on the official website. Otherwise, the project manager can be contacted by email and provide feedback to such inquiries within 3 working days.

Inquiry-based communication

Inquiry-based communication may be initiated by the review team so applicants should stay attentive to provide feedback as required.

By Yu fang. Contact Cisema if you would like to learn more.

Tagged under: drugs

What you can read next

14th Five-Year
14th Five-Year Plan for Drug Supervision Network Security and Information Construction in China
New NMPA Classification Catalogue for Medical Devices
Technical Review Guidelines in Draft for Medical Devices Clinical Trial Data Submission

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 medical device sampling inspection results

    China medical device sampling inspection results no.4 of 2022

    China medical device sampling inspection result...
  • NMPA cosmetic sampling inspection

    The NMPA Cosmetic Sampling Inspection measures come into force on March 1, 2023

    NMPA Cosmetic Sampling Inspection Measures come...
  • China cosmetics quality safety responsibilities

    China cosmetics quality and safety responsibilities regulations released

    China cosmetics quality and safety responsibili...
  • 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...

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.