You are using an outdated browser and your browsing experience will not be optimal. Please update to the latest version of Microsoft Edge, Google Chrome or Mozilla Firefox. Install Microsoft Edge

August 26, 2016

Vietnam’s New Pharmaceutical Law

Subscribe to Updates
Informed Counsel

The National Assembly of Vietnam adopted a new Law on Pharmacy on June 4, 2016. The new law will take effect on January 1, 2017, replacing the current version which was passed in 2005. In an effort to update certain aspects of Vietnam’s legal framework to be more in line with international practices, the new pharmaceutical law is expected to provide quicker access to drugs for patients, increased consumer protection, and more incentives for local manufacturing of drugs.

Removing the Five-Year Rule for Clinical Trials

Under the Law on Pharmacy of 2005, which is currently in effect, before a new drug can be circulated in Vietnam, it must undergo clinical trials in Vietnam for registration purposes. The drug is only exempted from this requirement if it has already been circulated legally for at least five years in its country of origin. As a result, unless costly and cumbersome clinical trials are performed, Vietnamese patients have to wait at least five years to gain access to new drugs that have already been approved for circulation in other countries.

Under the new Law on Pharmacy, this barrier has been lifted. Accordingly, the clinical trial requirement would be waived for all new drugs, except vaccines, provided that they have sufficient clinical data on safety and efficiency and are circulated in at least one country anywhere in the world. With this change, Vietnamese patients will gain earlier access to new drugs, especially those that treat life-threatening diseases. Pharmaceutical companies will also benefit by not being forced to repeat clinical trials that have already been performed.

Expanding Retail of OTC Drugs

The new Law on Pharmacy allows certain non-prescription drugs, also known as over-the-counter (OTC) drugs, to be sold by a business establishment that does not have a certificate of eligibility for pharmaceutical business. These establishments include, among others, venues that have drug counters or cabinets, such as supermarkets.

Although the list of OTC drugs is not yet available and the relevant establishments still need to satisfy certain criteria on storage conditions and human resources, this is still a major change, as it appears likely to provide consumers with improved access to certain OTC drugs.

Acknowledging Patient Assistance Programs

Article 42 of the new law permits pharmaceutical companies to provide free drugs to health establishments through a patient assistance program. Previously, pharmaceutical companies always had to be concerned as to whether directly conducting such programs would be in breach of the law, as conducting promotional activities in relation to drugs targeting patients is prohibited in Vietnam.

Recognizing Clinical Pharmacology

The new Law on Pharmacy provides a separate chapter dedicated to clinical pharmacology, instead of scattered regulations as in the previous law. The purpose of this chapter is to ensure that drugs will be used in a reasonable, safe, and effective manner. While the contents of this chapter are cursory, its existence suggests that the government views clinical pharmacology and drug safety as an important issue.

Permitting Parallel Imports

  The new Law on Pharmacy specifically allows parallel import of drugs as long as the price of the parallel-imported product is lower than the price of the original brand-name drug currently being circulated in Vietnam. Though the general concept of parallel imports is not new to the pharmaceutical industry in Vietnam, this is the first time that a regulation on parallel imports has been promulgated under a law.

Incentivizing Local Manufacturing

The new Law on Pharmacy clearly shows that national policy prioritizes the purchase of domestically produced products, including domestically manufactured generics and biosimilars, herbal and traditional medicines manufactured from domestic herbal ingredients, and drugs manufactured in domestic facilities meeting good manufacturing practice standards.

Moreover, the new law reflects a preferential treatment for domestically produced drugs over imported drugs that first appeared in the Law on Procurement. That is, when domestically produced drugs are available that satisfy the Ministry of Health’s requirements on medical treatment, price, and supply, the dossier for a drug tender must stipulate that tenderers are not allowed to offer imported drugs. As a result of those regulations, there are more foreign pharmaceutical companies considering the option of going “local.”

Summary

The new Law on Pharmacy represents a milestone achievement in healthcare in Vietnam and is likely to have a major impact on patients and pharmaceutical companies, with the key benefit for consumers being earlier access to pharmaceutical products, due to the removal of the clinical trial requirement. As the new Law on Pharmacy is of critical importance, the government will likely issue a large number of decrees and circulars that will guide the implementation of the new law when it takes effect next year.

Download Full Article
Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

November 25, 2025
Food safety incidents can emerge without warning, requiring businesses to act swiftly to protect consumers and comply with regulatory obligations. Across Southeast Asia, Thailand, Vietnam, and Indonesia have each developed comprehensive food recall frameworks designed to ensure rapid removal of unsafe products from the market while holding businesses accountable for compliance failures. While these three jurisdictions share common objectives—protecting public health and ensuring food safety—each has crafted distinct regulatory approaches reflecting their unique administrative structures, enforcement priorities, and legal traditions. Understanding these differences is essential for food businesses operating in the region, as recall procedures, timelines, reporting requirements, and penalties vary significantly across borders. This guide, available through the button below, examines the food recall regulations in Indonesia, Thailand, and Vietnam, providing practical guidance on legal requirements, procedural steps, and compliance obligations in each market.
Read More
October 15, 2025
The Indonesian Food and Drug Administration (BPOM) has introduced more stringent oversight of health supplements containing probiotics with new guidelines that require clinical trials for certain products and expanded documentation standards. BPOM Regulation No. 17 of 2025 replaces the previous 2021 regulation and establishes a comprehensive framework for evaluating probiotic strains used in health supplements. Assessment Requirements The new regulation expands the scope of assessment to include not only categorization and documentation but also technical procedures, strain classification, and clinical trial requirements. Unlike the previous regulation, which provided general guidance, the updated framework creates a comprehensive system for evaluating both registered probiotic strains and new or combined strains. Manufacturers must now submit supporting documentation covering strain identification and functional characterization, safety, efficacy, and product quality. The previous regulation required documentation only on safety, efficacy, and quality. Clinical Trials One of the most significant changes is the requirement for clinical trials conducted in Indonesia for applications that include benefit claims other than maintaining digestive health, or where there are modifications to benefit claims. The regulation specifies that phase 1 trials must demonstrate safety, while phase 2 trials must validate efficacy using statistically valid methods such as double-blind, randomized, placebo-controlled studies). In addition, phase 3 and phase 4 trials may be required, and postmarket surveillance data must be submitted. Technical Assessment Framework Annex 4, a newly introduced section, establishes technical procedures for assessing health supplements containing probiotics in Indonesia. This comprehensive framework outlines criteria for evaluating new probiotic strains, including strain identification, functional characterization, safety, efficacy, and product quality. The annex introduces a clear classification of claims for health supplement products containing probiotics: General claims(e.g., maintaining digestive health). Functional claims(e.g., normal biological function or activity in the body). Risk reduction claims(e.g., lowering disease risk). The regulation restricts use of the term
Read More
October 3, 2025
On September 26, 2025, the Contract Committee under Thailand’s Consumer Protection Board issued a regulation that aims to standardize contracts and enhance consumer protection within the beauty and wellness industry. The Notification on Prescribing the Beauty Service Business as a Contract-Controlled Business B.E. 2568 (2025), which takes effect on January 24, 2026, requires business operators to use a prescribed standard contract in Thai and adhere to strict mandatory provisions and prohibitions. These regulations apply to operators across all in-person and online service channels, including via digital platforms. “Beauty services business” is defined as the provision of services under an agreement allowing consumers to receive a series of treatments, either over a set number of sessions or within a set period. This includes massage, spa, other methods for cleanliness, beauty, or care of facial or body skin, and weight control and body shaping—including services offered electronically. The law excludes surgery, liposuction, and medical treatments performed by licensed practitioners. The notification establishes the following key requirements: Mandatory contract and formatting. All contracts with consumers must use the standard contract form, in Thai, with clear, readable text (minimum font size of 2 millimeters, no more than 11 characters per inch), and include all essential terms from the annexed form. Contract execution. Contracts must be made in duplicate, with one copy given to the consumer at signing. For agreements concluded through electronic channels, the process must comply with the Electronic Transactions Act and use the same required terms. Digital platforms. Business operators who provide services facilitated through a digital platform as an intermediary are ultimately responsible for ensuring the consumer receives a compliant contract. Prohibited clauses. The law prohibits clauses that limit or exclude liability for damages to life, body, health, mind, or property resulting from breach of contract or a wrongful act;
Read More