What is it about?
In China, medical doctors doubt the efficacy and quality of generic drugs manufactured domestically. To address these concerns, the Chinese State Council released a policy in 2016 to ensure the interchangeability by re-evaluating the quality and efficacy of generic drugs. It intends to make up a missed lesson in the regulation to be in line with internationally accepted practices.
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Why is it important?
The policy could achieve several benefits by increasing confidence on the Chinese produced generic drugs, upgrading regulatory standards, streamlining the Chinese generic drug industry and creating a healthy competition market.
Perspectives
Enormous challenges remain in enlarging the capacity to review applications, selecting appropriate comparators, ensuring the capacity of domestic clinical research sites, and achieving the acceptance of re-evaluated generic drugs.
Baobin huang
China National Institute for Food and Drug Control
Read the Original
This page is a summary of: Make up a missed lesson-New policy to ensure the interchangeability of generic drugs in China, Pharmacology Research & Perspectives, May 2017, Wiley,
DOI: 10.1002/prp2.318.
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