Overview:
On April 23, 2020, China’s NMPA issued the revised Standard for Quality Control of Drug Clinical Trials (No. 57 of 2020). The Standard will be implemented on July 1. The NMPA stated that the emergence of new concepts and the application of new technologies in the field of drug clinical trials, such as risk-based quality management and Electronic data, have not been included in the past standards. The new drug clinical trial standards and the recently passed “Drug Management Law “, are now both consistent with the basic requirements of ICH technical guidelines, detailing the clear responsibilities of all parties in drug clinical trials.
Revised Key Points:
Clinical Trial Participants Responsibilities:
- The Ethics Committee clarifies its composition and operation, ethics review, and procedure documents.
- The Sponsor is the ultimate responsible person for the quality and reliability of clinical trial data and the supervision of outsourcing work.
- The Contract Research Organization (CRO) shall implement quality assurance and quality control.
- The investigator has the authorization and supervision responsibilities for the division of clinical trials.
- The Clinical trial institution shall establish a corresponding internal management department to undertake the corresponding management of clinical trials.
Establish a quality management system
- The sponsor should establish a quality management system for clinical trials, conduct quality management based on risks, strengthen quality assurance and quality control, and can establish an independent data monitoring committee to carry out monitoring based on risk assessment.
- Researchers should supervise each other researchers to implement the test plan and implement clinical trial quality management to ensure that the source data is true and reliable.
Regulate the application of new technologies
The electronic data management system should pass the reliable system verification to ensure the completeness, accuracy and reliability of the test data. When the information system of a clinical trial institution has the conditions for establishing a clinical trial electronic medical record, researchers should first use it, and the corresponding computerized system should have perfect authority management and audit trails.
Refer to international clinical supervision experience
- The implementation of clinical trials should abide by the principle of conflict of interest avoidance; bio-equivalence trials should be sampled and preserved for clinical trials; medical history records should record the specific time and personnel of the subject’s informed consent;
- If personnel are not holding up to quality standards , the sponsor can hold the relevant personnel accountable and report to the drug regulatory department.
The medical management requirements of the competent health department
- The composition and filing management of the ethics committee should meet the requirements of the department and health authorities;
- The sponsor should report suspicious and unanticipated serious adverse reactions to the drug regulatory and health authorities.
About Global Regulatory Partners:
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.
GRP Clinical Trial Expertise:
Global Regulatory Partners, Inc has extensive experience for establishing QMS system, conducting mock inspection in china, and CRO experience in Clinical Trials in China. To learn more, please contact us at info@globalregulatorypartners.com