Hard Time for Drug Regulators

The Center for Drug Evaluation under the National Medical Products Administration is the key regulator to gauge the efficiency and safety of new Chinese drugs over the past 33 years. Starting from early 2019, however, the agency was reported to be unable to pay its employees on time, and the program to enroll more staff was suspended because of financial shortfalls. To make matters worse, many senior staff resigned for jobs with better pay or titles because of the relatively low payment and high risk of drug examination in the agency. Since 2015, at least 22,000 new drug applications have been waiting to be reviewed at the drug evaluation center. In 2018, only 48 new drugs were approved by the agency, including 38 imports. Experts cautioned that it is urgent to train and retain more regulatory staff and introduce advanced management experience from developed countries.