China’s National Medical Product Administration (NMPA) released on July 2020 a guideline focused on the emergency approval of the new COVID-19 virus drugs and vaccines for sponsors and researchers. The guideline focuses on the quality and data collection of clinical trials to ensure they are true, accurate, complete and traceable.
Guideline Key Focuses:
This guideline is recommended for the emergency approval of a new drug and/or vaccine for COVID-19 clinical trials. Topics covered by this guideline are:
- This includes the protection and rights of interest of human subjects under the Code of Quality management of Drug Clinical trials (aka GCP) and ICH for protection of human subjects.
Drug alert and risk management
- The CRO should take safety measures and should identify risk and come up with risk assessment and risk management outcomes. In case a Suspected Unexpected Serious Adverse Reaction (SUSAR) occurs, the CRO should timely report the potential safety risk and control measures.
Compliance with code of quality management for drug clinical trials
- Clinical trial quality management practices should be followed to ensure the test data are true and reliable. The applicant needs to submit reports to the Ethics Committee (EC) and EC will determine the Quality Management Practices are maintained by the CRO.
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