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China set to hasten process of approving foreign drugs
March 21, 2017, 5:47 am

High drug costs and a lack of access to the most recent treatments is a major flashpoint in China [Xinhua]

China is considering taking measures to shorten the time to market for approved imported drugs, the Food and Drug administration said in a document published on its website.

Beijing is seeking public opinion for a draft plan to hasten the process of approving foreign drugs to be sold in the Chinese mainland.

China is the world’s second-largest drug market.

The China Food and Drug Administration has announced that imported drugs would be allowed to directly apply for market authorisation once completing international multi-centre clinical trials.

The proposed changes to current clinical trial requirements were in response to public demand for new drugs.

The body proposes eliminating a requirement asking applicants who intend to conduct an international multi-centre clinical trial in China for drugs, apart from vaccines, to obtain prior foreign approval or be currently in phase II or III clinical trials overseas.

A report in state-run Global Times said the move would boost imports from India, US, Japan and the European Union. India, known as “the pharmacy of the world” for its generic medicine, would also benefit from the policy, said experts.

In the past decade, BRICS countries – in addition to emerging markets like Kenya, South Korea, Cuba, Egypt and others – have aggressively pushed their research and development in the pharmaceutical industry to offer cheap generic drugs to their populations.

Data provider IMS Health says India and China are expected to consume medicines at a faster rate than any other country over the next five years.

 

TBP and Agencies

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