Access to medicines

China will accept data from overseas clinical trials to hasten drug approvals

Access to medicines could be hastened in China after the country’s said it planned to accept data from overseas clinical trials for the first time.

The move is intended to address the high costs of medicines and make access to healthcare for China’s 1.4 billion population more comparable with international levels of access to drugs. Global pharmaceutical firms face growing competition and pressure from Chinese firms to keep prices down.

The draft proposals from the State Council of the People’s Republic of China said approval for urgently needed drugs and medical equipment should become faster. The proposals include creating a catalogue of marketed drugs, improving the protection of drug trial data and building a system linking drug approvals and patient access to data. They also proposed increasing the number, and improving the quality, of clinical trial testing centres in China.

“Overall, China’s support for scientific innovation with drugs and medical devices is lacking, and the quality of products on the market still falls short of top international levels. We must speed up the examination and approval of urgently needed drugs and medical devices,” said a Council statement.

The world’s second largest pharmaceutical market, China, has increasingly opened up to new drugs over the past five years. In that time, 100 new drugs have been approved — around a third of those generally approved in most healthcare markets.

No details were given on a timeline for implementation for the proposals.

“We want to make our drug industry large scale and strong and shift our long-term reliance on imports of new drugs,” deputy head of the China Food and Drug Administration Wu Zhen . “[Some drugs] have been used overseas for six to seven years before making it to [the] market in China.”

Citation: The Salvadore DOI: 10.1211/PJ.2017.20203714

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Introduction to Statistics in Pharmaceutical Clinical Trials

    An innovative book which presents statistics in the context of clinical trials conducted during pharmaceutical drug development.

  • Principles of Good Clinical Practice

    A one-stop source for the proper conduct of clinical trials. Essential information on clinical trial design and pharmacovigilance.

  • Clarke's Analysis of Drugs and Poisons

    Clarke's Analysis of Drugs and Poisons is the definitive reference source of analytical data for drugs and poisons.

  • Handbook of Drug Administration via Enteral Feeding Tubes

    All you need to know about prescribing or administering drugs via enteral feeding tubes. Over 400 drug monographs as well as facts to inform clinical decision making.

  • Handbook of Pharmaceutical Excipients

    The Handbook of Pharmaceutical Excipients contains essential data on the physical properties of excipients, their safe use and potential toxicity.

  • Clinical Pharmacy Pocket Companion

    An A-Z pocket book containing concise and practical pharmaceutical information for busy clinical pharmacists.


Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete

Supplementary images

  • China pharmacy

Jobs you might like

  • Leeds, West Yorkshire

  • Hertfordshire

  • Corsham, Wiltshire

  • Orpington (City/Town), London (Greater)

  • Wellington Road Surgery, Newport, Shropshire

See more jobs

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.