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Queue for drug registrations grows longer in China

BMJ 2015; 350 doi: (Published 23 March 2015) Cite this as: BMJ 2015;350:h1596
  1. Jane Parry
  1. 1Hong Kong

China’s Center for Drug Evaluation has reported a large rise in the backlog of drug registration applications, up by a third in 2014 compared with the previous year. Industry observers attribute this to severe understaffing at the agency, an increasing number of applications, and the requirement for clinical trials to be conducted in Chinese populations as a prerequisite for registration.

In its annual report the centre said that it had 18 597 applications awaiting approval at the end of 2014, which included new drug applications, renewals for drugs that must be completed every five years, and change applications (for different dosage, alternative route …

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