• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • Clinical Trial Listings
    • What are Clinical Trials?
    • Become a Clinical Trial Volunteer
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • Benchmark Reports
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » China to reform drug approval system

China to reform drug approval system

August 20, 2015
CenterWatch Staff

China has decided to reform its appraisal and approval system for drugs and medical instruments with the aim of improving drug safety and quality and encouraging innovation.

According to a guideline issued by the China State Council on Aug. 18, China aims to set up a more scientific and efficient system to ensure the safety and quality of medicines and medical instruments that come into the market.

The relevant authorities will make efforts to strike a balance between the number of registration applications received and those that are approved by the end of 2016. They also will ensure that, by 2018, every application will be approved or rejected within a certain time limit.

The State Council requested that the approval standards for medicines should be improved by adjusting the classification of drug registration. The appraisal and approval process of innovative drugs will be accelerated, including drugs to treat AIDS, cancer, serious infectious and rare diseases.

Institutions and staff involved in the R&D of drugs will be allowed to apply for the registration of new drugs. Once these drugs are transferred to enterprises for manufacturing, no further appraisal will be required.

Approvals concerning the clinical trials of drugs and medical instruments will be further improved. Additionally, procedures on drug approvals will be simplified, so that applications for drugs and relevant packing and materials will be approved at the same time.

In order to enhance the transparency of approvals, information concerning drug supply and demand, as well as registration applications, will be released in a timely manner. The public will be able to view the list of approvals and make enquiries, if required, and applicants also will be informed of the approval process and results.

    Upcoming Events

    • 14Apr

      MAGI 2024: The Clinical Research Conference

    Featured Products

    • Surviving an FDA GCP Inspection

      Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

    • Best Practices for Clinical Trial Site Management

      Best Practices for Clinical Trial Site Management

    Featured Stories

    • Jonathan Seltzer

      Thought Leadership: Remote Patient Monitoring Gives New View of Safety in Cardiac Clinical Trials

    • Quality_Compass-360x240.png

      Ask the Experts: Applying Quality by Design to Protocols

    • Obesity Treatment Patient

      Clinical Trials Need Greater Representation of Obese Patients, Experts Say

    • Modernize-360x240.png

      FDA IT Modernization Plan Prioritizes Data-Sharing, AI, Collaboration and More

    Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

    The information you need to adapt your monitoring plan to changing times.

    Learn More Here
    • About Us
    • Contact Us
    • Privacy Policy
    • Do Not Sell or Share My Data

    Footer Logo

    300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

    Phone 703.538.7600 – Toll free 888.838.5578

    Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing