Common Technical Document (CTD) Acceptance
Vietnam uses the ASEAN Common Technical Dossiers (ACTD) application format for new drug registration.
Clinical Trial Data Requirements
Clinical trials must be conducted on drugs that will be used in Vietnam for the first time. To initiate a clinical trial, a sponsor prepares and submits a dossier to register a clinical trial, which is submitted to the Science and Training Department of the MoH. Contents of the dossier are unspecified.
15 working days after the receipt of a complete dossier, the Ministry of Health issues an approval letter which gives the sponsor clearance to submit a product dossier and clinical trial protocol to the Science and Technology Department of the MoH. Over a 60 day period, the Science and Technology Department and the Biomedical Council reviews the scientific and ethical aspects of the application, respectively. Within 15 days, the Science and Technology Department either notifies the Sponsor that clarification is necessary or that the application is being forwarded to the Minister for approval.
The following results of a clinical trial must be reported:
-Complete information on drug.
-Description of research protocol.
-Description of testing and data analysis procedure used.
-Evaluation of the results compared with the research tasks and objectives from the approved protocol.
-Objective and accurate conclusions.
Circular No. 03/2012/TT-BYT (February 2, 2012) (in Vietnamese) provides guidance on clinical trials.
Clinical Trials Import Authorization
Import clearance requires that the Investigator submit a letter of request for import to the DAD and written approval from the MoH clinical trial protocol.
Clinical Trial Estimated Timeline
According to Tilleke & Gibbins LLP, the Ministry of Health will issue an approval letter for a clinical trial within 15 working days of receiving a valid and completed dossier. Afterwards, the Science and Technology Council and Biomedical Research Ethics Council evaluate the dossier within 60 days. 15 working days later, the Science and Training Department will notify the trial sponsor and insitution if additional materials are needed or refer the dossier to the Minister for approval. More information is available here.
Clinical Trial Costs
No information found
In-Country Manufacturing Requirements
A manufacturer must obtain a Certificate of Satisfaction of Eligibility of Drug Business Conditions (Conditions Certificate) and a Certificate of Satisfaction of Principles and Standards of Good Manufacturing Practices (GMP Certificate). Within 40 working days of submitting an application for a Conditions Certificate, the DAV will decide whether to evaluate the Certificate. To obtain a GMP Certificate, an application is submitted to the DAV. Within 5 working days from the date of receiving the application, the DAV will notify the applicant if the application dossier is insufficient or of an examination plan for the manufacturing site. The DAV will conduct the examination within 20 working days of the original notification to examine the facility. Within 5 working days after the examination, the DAV is issue the GMP Certificate if the manufacturer is in compliance with GMP standards.
Precedent (Clinical Trials Approved/Denied in Last 2 Years)
2 clinical trials approved from June 2012 to June 2014.
Product Registration Data Requirements
Registration requirements are outlined in Circular No. 22/2009/TT-BYT (in Vietnamese). To receive marketing authorization, one must obtain a Drug Trading Certificate (for local drug registration applicants) or a Certificate of Operating in Medicinal Products and Raw Medicinal Materials in Vietnam(for foreign drug registration applicants).
Marketing authorization dossiers are submitted to the DAV. Vietnam adopted the ASEAN Common Technical Dossier (ACTD) format, which is organized in four parts:
1. Table of Contents, Administrative Data and Product Information
Section A: Introduction
Section B: Overall ASEAN Common Technical Dossier Table of Contents
Section C: Documents required for registration (for example, application forms, labeling, Product Data Sheet, prescribing information)
2. Quality Document
Section A: Table of Contents
Section B: Quality Overall Summary
Section C: Body of Data
3. Nonclinical Document
Section A: Table of Contents
Section B: Nonclinical overview
Section C: Nonclinical written and tabulated summaries
-Table of Contents
Section D: Nonclinical study reports
4. Clinical Document
Section A: Table of Contents
Section B: Clinical Overview
Section C: Clinical Summary
-Summary of Biopharmaceutics and Associated Analytical Methods
-Summary of Clinical Pharmacology Studies
-Summary of Clinical Efficacy
-Summary of Clinical Safety
-Synopses of Individual Studies
Section D: Tabular Listing of All Clinical Studies
Section E: Clinical Study Reports
Section F: List of Key Literature References
Annually, the product license holder must report to the DAV on registered drugs that are not manufactured (domestically produced) or imported (foreign drugs).
Product Registration Timelines
According to Tilleke & Gibbins LLP, the Drug Administration of Vietnam will grant adequate and complete dossiers marketing authorization within 6 months.
Product Registration Costs
VND4.5 to 6 million
Post Registration Pharmacovigilance Requirements
Medical institutions and professionals, manufacturers, and distributors are required to report Adverse Drug Reactions (ADRs) to the Government. However, research and treatment facilities are not required to report. The MoH is responsible for monitoring ADRs. The DAV and Hanoi University of Pharmacy are responsible established the National Drug Information and Adverse Drug Reaction (DI-ADR) Monitoring Center, which is the primary component of the national pharmacovigilance system. Product license holders are required to notify the DAV of new information related to drug quality, safety, and effect and if any registered drugs in Vietnam have had their registration revoked in other countries.
Spetember 22, 2014.