Navigating drug registration in China: accelerated review policies and pathways

AdobeStock_642199734_small

Since joining the International Council for Harmonisation (ICH) in 2017, China has been committed to reforming its drug registration system to simplify application procedures and align with international standards. Despite significant progress, challenges remain. To address urgent clinical needs, China has introduced accelerated review policies and pathways for the registration of drugs for urgent clinical use, rare diseases and breakthrough therapies. This article provides an overview of the standard drug registration process in China and offers a detailed analysis of these accelerated pathways, outlining their requirements, benefits and timelines. Additionally, practical tips and strategic advice are shared to assist pharmaceutical companies in navigating these policies for faster market access in China.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to registered users and TOPRA members.

Already a member or have an account? Sign in.

1. REGISTER FOR FREE

Free access to selected content

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account

2. Members login

Already a TOPRA member?

Log-in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Login

3. JOIN TOPRA

TOPRA membership

Become a TOPRA member and join our global regulatory affairs community.

  • Great savings on our events and training.
  • Be part of our dynamic international community.
  • Contribute to the profession.
  • Grow your skills and knowledge.
  • Take your career to the next level.

Become a member