Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.


Subscribe or Register

Existing user? Login

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 government 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 said on Monday 9 October. “[Some drugs] have been used overseas for six to seven years before making it to [the] market in China.”

Citation: The Pharmaceutical Journal 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

  • Clinical Pharmacokinetics

    Clinical Pharmacokinetics

    A practical guide to the use of pharmacokinetic principles in clinical practice. Includes case studies with questions and answers.

    £33.00Buy now
  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Pharmaceutical Toxicology

    Pharmaceutical Toxicology

    Explains the methodology and requirements of pre-clinical safety assessments of new medicines. Includes registration requirements and pharmacovigilance.

    £40.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now

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

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • China pharmacy

Newsletter Sign-up

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