Regulations on Good Laboratory Practice (GLP) in Vietnam

(update Circular 36/2025/TT-BYT dated 11/9/20225)

Good Laboratory Practice (GLP) is a set of principles and standards for a quality management system related to the organization and conditions for conducting non-clinical research in pharmaceutical activities concerning human health and environmental safety, which is planned, implemented, monitored, documented, stored, and reported. The principles of good laboratory practice are stipulated in Circular 04/2018/TT-BYT, amended and supplemented by Circular 08/2020/TT-BYT. Recently, the Ministry of Health granted Circular 36/2025/TT-BYT, amending some articles on the decentralization of Circular 04/2018/TT-BYT, effective from September 11, 2025. In the following article, Viet An Law will update some notable contents regarding regulations on good laboratory practice (GLP) in Vietnam.

Principles of good laboratory practice

According to Article 3, Circular 04/2018/TT-BYT, the principles of good laboratory practice are as follows:

• WHO principles of GLP in the Appendix I attached to Circular 04/2018/TT-BYT;
• OECD principles of GLP in the Appendix II attached to Circular 04/2018/TT-BYT.

Accordingly, regulated entities include:

• Drug/starting material test facilities shall select to apply and comply with GLP principles themselves specified in the Appendix I or II;
• Vaccine testing facilities, medical biological product testing facilities, blood product testing facilities, and drug bioequivalence testing service businesses must implement and comply with GLP regulations as specified in Appendix II;
• Test facilities shall apply the updated GLP document within 12 months in case of change of analytical equipment or facility or within 06 months in case of other updates, from the date on which the updated document is published on the website of the Ministry of Health and the web portal of the Drug Administration of Vietnam.

Documents used as basis for inspection of compliance with good laboratory practice principles

According to Article 5, Circular 04/2018/TT-BYT, as amended and supplemented by Clause 1, Article 1 of Circular 08/2020/TT-BYT, documents used as basis for inspection of compliance with GLP by a test facility are those included in its application for certificate of eligibility for pharmacy business (the test facility is not required to submit these documents because they have been submitted when it applies for the certificate of eligibility for pharmacy business) prescribed in Article 38, Law on Pharmacy 2016 and Article 20, Decree 163/2025/NĐ-CP. Specifically, it includes:

• Form No. 10 in Appendix I attached to Decree 163/2025/NĐ-CP for issuance, reissuance or adjustment of the Certificate of eligibility for pharmacy business respectively;
• The technical documents about the test facility shall be prepared in accordance with guidelines for the site master file provided in the Appendix III attached to Circular 04/2018/TT-BYT or the site master file that is updated in case of change of scope of operation.

Note: Previously, Article 38, Law on Pharmacy 2016 was guided by Article 32, Decree 54/2017/ND-CP. However, from July 1, 2025, Decree 54/2017/ND-CP has been replaced by Decree 163/2025/ND-CP.

Moreover, documents used as basis for inspection of compliance of a non-commercial test facility with GLP principles include:

• An application form (Form No. 01 in Appendix V attached to Circular 04/2018/TT-BYT);
• Technical documents about the test facility that are prepared in accordance with guidelines for the site master file provided in the Appendix III attached to Circular 04/2018/TT-BYT.

In cases where a testing facility requests a GLP certificate along with a certificate of eligibility for pharmacy business, the testing facility must clearly state this in the application for certificate of eligibility for pharmacy business.

Authority for inspection of compliance with good laboratory practice principles

According to Clause 1, Article 6, Circular 04/2018/TT-BYT, as amended and supplemented by Circular 08/2020/TT-BYT, the Drug Administration of Vietnam – the Ministry of Health has the authority to inspect the compliance with GLP principles.

In case the facility that only provides bioequivalence study services applies for issuance of the certificate of eligibility for pharmacy business shall submit an application according to regulations of the Minister of Health on good clinical practice.

Procedures for inspection of compliance with good laboratory practice principles

According to Article 6 of Circular 04/2018/TT-BYT, as amended and supplemented by Circular 08/2020/TT-BYT, procedures for inspection of compliance with GLP principles are as follows:

Receipt of application:

The test facility shall submit 01 application and pay assessment fees to the Drug Administration of Vietnam – the Ministry of Health.

Procedures for receiving and inspecting an application

• Within 05 days from the date of receiving a valid application, the Drug Administration of Vietnam shall establish an inspectorate, notify the testing facility about the inspectorate and the expected time for the on-site evaluation at the test facility;
• Within 15 days from the date of notification, the inspectorate shall carry out an on-site inspection at the test facility.

Procedures for inspection and classification of compliance with GLP principles are as follows:

• Step 1. The inspectorate shall declare the Decision on establishment of inspectorate, purposes and contents and plan for the site inspection at the test facility;
• Step 2. The test facility shall make a brief introduction of organization, personnel, application of GLP principles or specific contents in conformity with the inspected contents;
• Step 3. The inspectorate shall inspect and assess the application of GLP principles at the test facility;
• Step 4. The inspectorate shall hold a meeting with the test facility to inform deficiencies identified during the inspection (if any); assess the degree of each deficiency; discuss with the test facility about its dissenting opinions about the assessment of each deficiency; assess the degree of compliance of the test facility with GLP principles;
• Step 5. An inspection record is prepared and signed;
• Step 6. Completion of the inspection report.

The degree of compliance of a test facility with GLP principles shall be assessed and includes:

• GLP degree 1 test facility;
• GLP degree 2 test facility;
• GLP degree 3 test facility.

Notes regarding new authority under regulations on good laboratory practice (GLP) in Vietnam in Circular 36/2025/TT-BYT

Authority to assess the notification of change of the test facility

During the interval between periodic inspections, the test facility shall send a notification of change made using the Form No. 05 in the Appendix V attached to Circular 04/2018/TT-BYT in one of the following cases:

• Expansion of the existing laboratory;
• Major change in the structure and layout of the laboratory;
• Change of the auxiliary system or change of principles of design and operation of the utility system which affects the laboratory environment.

Accordingly, previously, Clause 4, Article 11 of Circular 04/2018/TT-BYT stipulated that test facilities undergoing changes falling under one of the above cases shall submit a notification of change enclosed with technical documents corresponding to the change to the Drug Administration. The Drug Administration of Vietnam shall assess the notification of change sent by the test facility.

However, this regulation was amended by Clause 1, Article 1 of Circular 36/2025/TT-BYT, effective from September 11, 2025, as follows: “The test facility that makes one of the changes specified in points d, dd and e clause 1 of this Article shall submit a change report enclosed with relevant technical documents to the Department of Health of the province where the laboratory is located. The Department of Health shall assess the change report sent by the test facility.”

Therefore, according to this new regulation, the authority to assess the notification of change of the test facility will be transferred from the the Drug Administration of Vietnam – the Ministry of Health to the Department of Health in the locality where the laboratory is located. At the same time, the processing time for applications is also stipulated as follows:

• Within 07 working days from the date on which the change report is received, the Department of Health shall send a written consent to the change in case the change complies with GLP principles. Within 03 working days from the date on which the written consent to the change is sent, the Department of Health shall publish the written consent to the change on its website.

Previously, according to Circular 04/2018/TT-BYT, the deadline for issuing a notification agreeing to the changes, if the changes met the requirements, was 10 days, and there was no regulation regarding the publication of the notification agreeing to the changes on the website.

Amend and supplement regulations on the responsibilities of the Department of Health regarding good laboratory practice.

Clause 2, Article 1 of Circular 36/2025/TT-BYT amends the regulation in Clause 2, Article 18, Circular 04/2018/TT-BYT regarding the responsibilities of the Department of Health concerning good laboratory practice as follows:

• Cooperate with relevant units in disseminating this Circular and provide guidelines for its implementation for units within their provinces;
• Join the inspectorate for inspection of compliance with GLP principles; carry out supervision and take actions against violations of regulations on compliance of test facilities within their provinces;
• Assess change reports of test facilitie according to regulations;
• Publish written consents to changes on their website and send them to the Ministry of Health (the Drug Administration of Vietnam).

This new regulation has added the responsibility to assess change reports from testing facilities and publish them on the unit’s website, and to send a notification to the Ministry of Health (the Drug Administration of Vietnam) confirming agreement with the changes, in order to align with the Ministry of Health’s new authority to assess the notification of change of the test facility.

The above is an update on the regulations on good laboratory practice (GLP) in Vietnam. If you have any related questions or require legal advice regarding the assessment of compliance with good laboratory practice, please contact Viet An Law for the best advice and support!