China publishes major revisions to pharmaceutical registration requirements

Changes to pharmaceutical registration regulations in China that go into effect on July 1 are designed to bolster safety requirements for clinical trials, encourage the development of generic drugs, limit fraud in clinical data and expedite the pharmaceutical approval process.

For example, similar but not the same as the US, China has initiated 4 fast-track approval categories including – 1. Breakthrough, 2. Priority review, 3. Fast approvals, and 4. Special approval process.

Published by China’s National Medical Products Administration, the revisions are the latest step in China’s efforts to improve the safety and accessibility of much-needed drugs. They are the first changes to the country’s drug registration regulations in two years.