MEDICINAL PRODUCT REGULATION AND PRODUCT LIABILITY IN VIETNAM

Medical equipment and pharmaceuticals are special commodities, directly related to the health and life of everyone. The State currently has strict regulations on this issue due to the importance of these kinds of goods. In order to have a better point of view in Medicinal product regulation and product liability in Vietnam, Doanh Tri will make an attempt to shed more light on this issue.

I. Regulatory overview

1. Legislations

- Law on Pharmacy 2016;

- Decree No. 54/2017/ND-CP guiding the implementation of the Law on Pharmacy;

- Decree No. 54/2017/ND-CP guiding the implementation of the Law on Pharmacy;

- Circular No. 01/2018/TT-BYT dated 18 January 2018 on labeling and package inserts for drugs and drug materials;

- Circular No. 11/2018/TT-BYT dated 4 May 2018 on quality of drugs and drug materials

- Circular No. 29/2018/TT-BYT dated 29 October 2018 on clinical trials of drugs.

2. Regulatory authorities

The national authorities (The Government) have full jurisdiction over the management of drugs, biologicals, and medical devices in Vietnam. In particular, the Ministry of Health has general responsibility in these areas. Subdivisions, such as Drug Administration (DAV), have specific responsibilities in certain areas.

The Drug Administration of Vietnam is responsible for the following areas:

- Developing and issuing legal documents on pharmaceuticals and cosmetics;

- Managing the registration and circulation of medicinal products and cosmetics;

- Co-ordinating clinical trials in Vietnam with the Administration of Science, Technology, and Training, under the Ministry of Health;

- Managing drug and cosmetics advertising;

- Managing and coordinating with the competent authorities drug prices, stabilization measures in the drug market, and tenders in hospitals;

- Overseeing the implementation of provisions relating to drugs and cosmetics and imposing sanctions for violations;

- Defining pharmaceutical products.

The Department of Medical Equipment and Construction (DMEC) and provincial Departments of Health are the regulatory authorities for supervising medical devices in Vietnam.

3. Clinical trials

3.1. Regulatory authorities

Clinical trials must be conducted for medicinal products in certain cases for registration purposes. Clinical trials of finished medicines, pharmaceutical chemicals, pharmaceutical materials, vaccines, and medical-biological products are governed by Law on Pharmacy and the following regulations:

- Decree No. 54/2017/ND-CP on implementing the Law on Pharmacy;

- Circular 29/2018/TT-BYT of the Ministry of Health dated 29 October 2018 on clinical trials of drugs.

The main authorities have responsibilities for evaluating and approving applications for clinical trials are:

- Administration of Science, Technology, and Training of the Ministry of Health;

- Ministerial-level Science and Technology Council of the Ministry of Health;

- Ministerial-level Biomedical Research Ethics Council of the Ministry of Health.

3.2. Trial condition

Before conducting a clinical trial, all parties must agree on research protocols and monitoring and supervision of work. Additionally, the contract research organizations and the site management organizations must be registered with the Administration of Science, Technology, and Training and must obtain an Operation Licence in research-supporting activities before participating in each clinical trial.

Clinical trial agencies must:

- Have scientific research functions.

- Operate independently (that is, without economic or organizational relations to individuals or organizations that have medicines under trial).

- Maintain satisfactory conditions for material foundations, medical equipment, and facilities.

- Make sure that research personnel is suitable for each trial.

This ensures compliance with principles of good clinical practice (GCP) and the conduct of safe and effective studies.

All investigators must:

- Have a diploma and professional certificate granted or recognized in Vietnam that is suitable for the position.

- Have a valid practicing certificate that is suitable to the assigned work (for jobs that require a practicing certificate).

- Have a GCP Course Completion Certificate issued by the Ministry of Health or a facility with GCP training functions, updated periodically every three years.

- Have a certificate of completion of the safety reporting course in clinical trials under GCP issued by the Ministry of Health or a facility with the function of training on safety reporting in clinical trials, updated periodically every three years.

For principal investigtors:

- Have sufficient specialized knowledge, clinical experience, and practical capacity to ensure GCP principles, have good knowledge of clinical trial regulations and be able to implement the protocol fully and on schedule.

- Not preside over more than three clinical trial studies.

The research team must have sufficient members and components suitable for the assigned work and have enough time for research.

3.3. Consent

Volunteers participating in the trial must:

- Have the full legal capacity to consent.

- Meet medical requirements.

- Sign written commitments with the organization agreeing to conduct clinical trials of medicines.

3.4. Procedures

- Phase 1. The new active ingredient or new formula is first tested on humans. This is a preliminary assessment of the safety of the drug.

- Phase 2. Testing to determine the optimal dosage for the trial and to demonstrate the treatment efficiency and safety of the drug, including the immunogenicity of a tested vaccine on the target subject.

- Phase 3. Testing on a larger number of patients. The objective is to determine the stability of the drug formula, the safety, and the general treatment efficiency, or to assess the protective efficacy and the safety of the tested vaccine on the target subject.

- Phase 4. Post-marketing study. The objective of this phase is to continue assessing the safety and the treatment efficiency and monitor the protective efficacy of the vaccine during post-marketing in compliance with the conditions for use.

III. Marketing

Marketing activities of drugs include:

- Promotion.

- Advertising.

- Drug introduction seminars.

- Dissemination of drug information material to healthcare professionals.

- Trade fairs and exhibitions.

For the promotion of drugs, it is prohibited to promote any drugs used for human treatment (such as: giving free samples), except for promotion among drug traders/distributors. The promotion of drugs to end-users or health professionals is strictly prohibited.

It is prohibited to advertise to consumers:

- Drugs without a valid marketing authorization (MA) number in Vietnam.

- Prescription drugs.

- Vaccines or medical-biological products used for disease prevention.

- Non-prescription drugs whose use should be restricted or should be supervised by a doctor, as recommended in writing by the competent state administrative body.

The advertising of drugs can be in the following forms:

- Advertisements in books, newspapers, magazines, leaflets, and posters.

- Advertisements on billboards, placards, panels, banners, objects which are illuminated or appear in the air or underwater, means of transportation, and other mobile objects.

- Advertisements on radio and television.

- Advertisements in electronic newspapers, company websites, and websites of advertising service providers.

- Advertisements on other means of advertising as permitted by law.

Selling restriction

The Law on Pharmacy sets out some restrictions on selling medicinal products and trading in medicines. It is prohibited to, among other things:

- Conduct business in medicines without a Conditions Certificate.

- Conduct professional pharmaceutical practice without a Pharmacy Practising Certificate.

- Sell certain medicines, including counterfeit medicines and poor-quality medicines.

- Sell medicines at locations that are not legal outlets for selling medicines.

- Sell prescription medicines without a prescription (over-the-counter medicines can be sold without a prescription).

The above information is about the ‘Medicinal product regulation and product liability in Vietnam.' For more information and advice on this issue, please contact Doanh Tri Law Firm directly via:

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