Chapter IV
FIRST ASSESSMENT OF GCP COMPLIANCE
Article 8. Applications for first assessment of GCP compliance
1. Documents used as basis for inspection of GCP compliance by a provider of trial services are those included in its application for certificate of eligibility for pharmacy business (the provider 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 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-CP dated May 08, 2017 on guidelines for the implementation of the Law on Pharmacy (hereinafter referred to as “the Decree No. 54/2017/ND-CP”). If a provider provides controlled drug trial services, it must have the documents prescribed in Article 38 of the Law on Pharmacy and Article 49 of the Decree No. 54/2017/ND-CP;
The technical documents about the provider of trial services prescribed in Article 38 of the Law on Pharmacy and Article 32 of the Government’s Decree No. 54/2017/ND-C shall be prepared in accordance with guidelines for the site master file provided in the Appendix II hereof or the site master file that is updated in the case of change of scope of operation and bear the seal of the provider of trial services.
If a provider of trial services applies for both certificate of GCP compliance and certificate of eligibility for pharmacy business, this content must be clearly specified in its application form for certificate of eligibility for pharmacy business.
2. An application used as the basis for inspection of GCP compliance by the trial facility specified in Point c Clause 1 Article 2 of this Circular include:
a) An application form for inspection of GCP compliance (Form No. 01 in the Appendix III hereof). If the trial facility applies for Certificate of GCP compliance, this content must be clearly specified in the application form;
b) Technical documents about the trial facility prepared in accordance with guidelines for the site master file provided in the Appendix II hereof and bearing the seal of the trial facility.
Article 9. Procedures for receipt of applications for inspection of GCP compliance
1. Receipt of applications:
a) The provider of clinical trial services and trial facility shall submit an application, which includes the documents specified in Article 8 herein, accompanied by the application fees in accordance with regulations of the Minister of Finance on fees for processing of applications for certification of clinical trial standards and conditions, to the Administration of Science Technology and Training - the Ministry of Health;
b) The provider of bioequivalence study services and bioequivalence study facility shall submit an application, which includes the documents specified in Article 8 herein, accompanied by the application fees in accordance with regulations of the Minister of Finance on fees for processing of applications for certification of bioequivalence study standards and conditions, to the Drug Administration of Vietnam - the Ministry of Health; The Drug Administration of Vietnam shall take charge of receiving applications and cooperate with the Administration of Science Technology and Training in inspecting GCP compliance.
2. Procedures for receiving and processing an application are specified in:
a) Clauses 2, 3, 4, 5 and 6 Article 50 of the Decree No. 54/2017/ND-CP if the applicant is a facility conducting clinical trials of narcotic drugs, psychotropic drugs, precursor drugs, pharmaceutical starting materials that are narcotic active ingredients, psychotropic active ingredients or drug precursors; combined drugs that contain narcotic active ingredients, psychotropic active ingredients or precursors;
b) Clauses 2, 3, 4 and 5 Article 51 of the Decree No. 54/2017/ND-CP if the applicant is a facility conducting clinical trials of toxic drugs, toxic medicinal ingredients; drugs and active ingredients on the list of drugs and active ingredients banned from certain fields;
c) Clauses 2, 4 and 5 Article 33 of the Decree No. 54/2017/ND-CP if the applicant is a trial facility other than the ones prescribed in Point a and Point b of this Clause.
3. Within 05 days from the date on which the satisfactory application is received, the Administration of Science Technology and Training or the Drug Administration of Vietnam (hereinafter referred to as “the receiving authority”) shall establish an inspectorate in charge of inspection of GCP compliance (hereinafter referred to as “the inspectorate”), notify the applicant of the site inspection conducted at its premise and the expected inspection date.
Within 15 days from the date of notification, the inspectorate shall conduct a site inspection at the facility as prescribed in Article 10 of this Circular.
Article 10. Process of inspection of GCP compliance
1. Inspection process:
a) Step 1. The inspectorate will declare the Decision on establishment of inspectorate, purposes and contents and plan for the site inspection at the trial facility;
b) Step 2. The applicant shall make a brief introduction of its organizational structure, personnel and implementation or application of GCP, or specific contents in conformity with the inspected contents;
c) Step 3. The inspectorate shall inspect and evaluate the application of GCP at the trial facility;
d) Step 4. The inspectorate shall have a talk with the trial facility about the degree of GCP compliance as prescribed in Article 7 of this Circular and any deficiencies found during the site inspection (if any); discuss with the trial facility in case the trial facility does not agree with the inspectorate about the inspection results.
dd) Step 5. An inspection record is prepared and signed as follows:
The inspection record shall be signed by the head of the trial facility and head of the inspectorate. The inspection record shall clearly specify members of the inspectorate, location, date and scope of the inspection and disagreements (if any) between the inspectorate and the trial facility about the inspection of GCP compliance. The record shall be made into 03 copies, among which one is kept by the trial facility and the others are kept by the receiving authority.
2. GCP inspection compliance report
a) After the site inspection, the inspectorate shall prepare a GCP inspection compliance report using the Form No. 02 in the Appendix III hereof, list and analyze the deficiencies (if any) that need to be rectified by the applicant, make a comparison of corresponding regulations specified in legal documents and assess the degree of GCP compliance as prescribed in Article 7 of this Circular;
b) In the cases where the trial facility does not agree with the inspection contents, within 30 days from the date of signing the inspection record, the trial facility shall send a written explanation to the receiving authority enclosed with evidences (such as documents, images, videos and certificates) related to such inspection contents;
c) Within 10 days from the date on which the written explanation is received, the receiving authority shall consider the GCP inspection compliance report and written explanation and consult experts in relevant fields (if any) and send a written response to the applicant. The written response shall clearly specify agreements and disagreements with the written explanation provided by the applicant. The abovementioned length of time shall not add to the time limit for inspection.
Article 11. Processing results of inspection of GCP compliance
1. If the GCP inspection compliance report indicates that the trial facility complies with GCP as prescribed in Clause 1 Article 7 of this Circular:
Within 10 working days from the date of signing the inspection record, the receiving authority shall request the Minister of Health to issue the certificate of eligibility for pharmacy business and issue the Certificate of GCP compliance according to Form No. 03 in the Appendix III hereof if the trial facility wishes to apply for the certificate of eligibility for pharmacy business. If the trial facility does not apply for issuance of the Certificate of GCP compliance, the GCP inspection compliance report that indicates the trial facility complies with GCP is valid to certify the trial facility complies with GCP and is used as the basis for requesting the Minister of Health to issue the certificate of eligibility for pharmacy business or the basis for conducting clinical trials if the trial facility is the one prescribed in Point c Clause 1 Article 2 of this Circular.
In the cases where the trial facility conducts clinical trials and trades in controlled drugs, within 20 days from the end of the site inspection at the trial facility and from the date of signing the inspection record, if the trial facility wishes to apply for the Certificate of GCP compliance, the receiving authority shall issue the Certificate of GCP compliance according to the Form No. 03 in the Appendix III hereof (and issue the certificate of eligibility for pharmacy business).
2. If the GCP inspection compliance report indicates that the trial facility is required to rectify deficiencies as prescribed in Clause 2 Article 7 of this Circular:
a) Within 05 working days from the end of the site inspection at the trial facility and from the date of signing the inspection record, the receiving authority shall submit a GCP inspection compliance report enclosed with a notification of deficiencies that need rectifying to the trial facility.
If the trial facility conducts clinical trials and trades in controlled drugs, within 15 days from the end of the site inspection at the trial facility and from the date of signing the inspection record, the receiving authority shall submit a GCP inspection compliance report enclosed with a notification of deficiencies that need rectifying to the trial facility.
b) Upon completion of deficiency rectification, the trial facility shall send a notification and documents (such as documents, images, videos and certificates) proving that all deficiencies specified in the inspection report are rectified;
c) Within 20 days from the receipt of the rectification report, the receiving authority shall consider it and conclude the degree of GCP compliance by the trial facility. To be specific:
- If results of deficiency rectification make the trial facility comply with GCP, the receiving authority shall comply with regulations specified in Clause 1 of this Article.
- If results of deficiency rectification show that the trial facility still fails to comply with GCP, the receiving authority shall request the trial facility in writing to keep rectifying deficiencies.
d) Within 06 months from the receipt of the notification of deficiencies that need rectifying, the trial facility shall submit a rectification report upon request. After the aforementioned deadline, if the trial facility fails to rectify deficiencies or the deficiency rectification documents are not satisfactory within 12 months from the first time it is submitted, the submitted application will be rejected.
3. If the GCP inspection compliance report indicates that the trial facility fails to comply with GCP as prescribed in Clause 3 Article 7 of this Circular:
Within 05 working days from the end of the site inspection at the trial facility and from the date of signing the inspection record, the receiving authority shall send a notification of failure to comply with GCP enclosed with a GCP inspection compliance report to the trial facility and shall not issue the Certificate of GCP compliance.
4. Within 05 working days from the issuance date of the certificate for eligibility for pharmacy business or the Certificate of GCP compliance, the receiving authority shall publish the following information on its website and web portal of the Ministry of Health:
a) Name and address of the trial facility that complies with GCP;
b) Full name of the person in charge, number of his/her practicing certificate;
c) Number of the certificate of eligibility for pharmacy business and Certificate of GCP compliance (if any);
d) Validity of inspection of GCP compliance and date of the next periodic inspection;
dd) The scope of operations of the trial facility.
Tìm kiếm
Thông tư 29/2018/TT-BYT (Bản Word)
Thông tư 29/2018/TT-BYT (Bản Pdf)