The Ministry of Health to require strengthening management in testing activities in Vietnam

The Ministry of Health to require strengthening management in testing activities in Vietnam (Internet image) 

Regarding this issue, LawNet would like to answer as follows:

On October 3, 2023, the Drug Administration of Vietnam (Ministry of Health) issued Official Dispatch 9564/QLD-CL on strengthening management in testing activities.

The Ministry of Health to require strengthening management in testing activities in Vietnam

To strengthen drug quality inspection and monitoring activities, ensure the quality of testing results, and fully and accurately evaluate drug quality, as a basis for drug quality management, the Drug Administration of Vietnam requests the Central Drug Testing Institute, Ho Chi Minh Institute of Drug Testing, National Institute for Testing Vaccines and Medical Biologicals, Departments of Health of provinces and centrally run cities, Testing Centers of provinces and centrally run cities (including Drug and Cosmetic Testing Center; Drug, Cosmetic and Food Testing Center) implement the following activities:

(1) Testing centers of provinces and centrally run cities:

- Review, amend, supplement, and complete the quality management system of the Drug Testing Department; maintain compliance with Good Laboratory Practice (GLP) principles and standards prescribed in Circular 04/2018/TT-BYT on Good Laboratory Practice or ISO/IEC 17025 - Quality management of testing and calibration laboratories.

- Strengthen management in testing activities, ensuring that chemicals, solvents, reagents, and standards used are appropriate and within their expiration date.

For chemicals, solvents, and reagents for which the manufacturer does not specify an expiration date, an assessment must be conducted to ensure the quality of the chemicals and solvents is of good quality and does not affect the test results. Do not use chemicals, solvents, reagents, or standards that have expired or do not ensure quality to test drug samples in accordance with current regulations.

- Carry out a full drug quality inspection according to drug and drug raw material quality standards approved and updated by the Drug Administration of Vietnam according to the provisions of Circular 11/2018/TT-BYT regulating the quality of drugs and medicinal ingredients and Circular 03/2020/TT-BYT amending and supplementing a number of articles of Circular 11/2018/TT-BYT (Consolidated Document No. 06/VBHN-BYT 2023).

- Develop plans and funding sources to ensure the necessary resources to implement and maintain Good Laboratory Practices (GLP)/ISO/IEC 17025 standards, including equipment, chemicals, solvents, standards, and standard operating procedures, to ensure the continuous conduct of the facility's testing activities; report to the Department of Health and competent authorities for consideration and approval according to the provisions of the law.

(2) Department of Health of provinces and centrally run cities:

- Strengthen the inspection and supervision of the Center's operations, promptly detect and rectify shortcomings, and ensure that the testing Center's GLP principles, standards, and ISO/IEC 17025 standards are maintained and met.

- Review, handle, or propose competent authorities to resolve the Testing Center's proposals to ensure technical conditions and facilities for the Center's operations.
and maintaining compliance with GLP standards/ISO standards at the center.

(3) Central Institute for Drug Testing, Ho Chi Minh Institute for Drug Testing, National Institute for Testing Vaccines and Medical Biologicals:

- Strengthen professional supervision activities and promptly detect and support testing centers to overcome shortcomings in expertise, as well as related contents.
During operation, maintain compliance with GLP/ISO/IEC 17025 standards.

- Propose to the Ministry of Health and competent authorities solutions to enhance the professional capacity of the Testing Center and the drug testing system in general.

More details can be found in Official Dispatch 9564/QLD-CL, dated October 3, 2023.

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