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China: CFDA proposes changes to drug laws as fast advance of reforms continues

2017/11/01

CFDA has moved quickly to enact changes since the State Council put forward proposals based on the agency’s own vision for the future of drug regulation in China earlier this month. The first text from CFDA emerged the day after the State Council’s proposals. Now, CFDA has released a more substantive set of draft documents to keep the reform agenda moving forward. The changes to the drug administration act are among the most far-reaching of those put forward by CFDA. If adopted, the amendments would support the build out of CFDA’s cadre of professional inspectors. CFDA wants to pair this expanded oversight force with stronger punishments for people found guilty of breaching its rules. Ten-year bans from the industry are one suggestion. Work still needs to be done to bring CFDA’s documents in line with the State Council’s vision of a faster regulatory system that encourages the development and adoption of innovative products. CFDA is moving toward this vision on multiple fronts. Two of these initiatives took a step forward this week with the publication of draft changes to the registration of clinical trial sites and the drug and medical device approval system. The agency is currently accepting feedback on all its recently released draft changes. More Information On RAPS