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​ 

September 20, 2023
Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid for seven years and could be renewed. The 2019 law also set out expiration dates for existing pharmaceutical products registered and approved prior to the implementation of the law (i.e., before October 13, 2019): Drug MAs issued before January 1, 1997, expire on October 13, 2024. Drug MAs approved between January 1, 1997, and December 31, 2007, expire on October 13, 2026. Drug MAs approved between January 1, 2008, and October 13, 2019, expire on October 13, 2028. Based on these dates, the first renewal period for drug MAs will commence in the fourth quarter of 2023. To facilitate the renewal process, the Thai Food and Drug Administration (FDA) has publicized draft regulations and notifications on the required application form and documents, the rules and conditions, and the process for renewing an MA. In May 2023, the Thai FDA issued Ministerial Regulation Re: Renewal of Drug MA Licenses B.E. 2566 (2023) to prescribe the essential requirements for filing a renewal application: To renew a drug MA, holders must submit their renewal application to the Thai FDA within the one-year period before the MA’s expiration date. Renewal applications can only be submitted online via the Thai FDA’s electronic system. The Thai FDA will grant approval for an MA renewal if the following conditions are satisfied: The documents in relation to efficacy and safety are up-to-date, accurate, and in accordance with academic principles. The specification and analytical method comply with the official pharmacopeias as prescribed in the Drug Act, as amended.
Read More
September 15, 2023
In May 2023, Thailand issued a regulation on conditional approval for emergency use of medicinal products, replacing a series of similar notifications that had been issued to aid mitigation efforts during the COVID-19 pandemic. During the pandemic, regulatory authorities worldwide—including the Thai Food and Drug Administration (FDA)—reshaped the approval pathway for emergency drugs intended for the treatment of COVID-19. The Thai FDA published five Notifications Re: Conditional Approval for the Emergency Use of Medicinal Products to outline the registration requirements and channels of distribution for drugs intended for the diagnosis, treatment, or prevention of COVID-19. As the threat from COVID-19 was receding, the Thai FDA saw fit to prepare for the potential emergence of other serious communicable diseases by enabling the supply of timely medications for disease diagnosis, treatment, and prevention. The Thai FDA therefore cancelled the five COVID-19-related emergency use notifications, which were published in 2020 and 2022, and replaced them with the Notification Re: Conditional Approval for Emergency Use of Medicinal Products published in May 2023. Under the May 2023 FDA notification on emergency use, conditional approval can be applied to drugs supported by empirical scientific evidence demonstrating their capacity to diagnose, treat, alleviate, cure, or prevent a serious communicable disease. The drugs eligible for approval under this new emergency pathway include novel drugs that are not yet approved in Thailand, as well as existing drugs approved in Thailand but recently discovered to have additional potential indications for the diagnosis, treatment, alleviation, cure, or prevention of a serious communicable disease. Distribution The 2023 FDA notification also clearly defines permissible distribution channels based on the dosage form of drug products: Vaccines can be distributed to governmental organizations that have a duty to prevent or treat diseases, such as the Thai Red Cross Society (TRCS), the Government Pharmaceutical Organization
Read More
September 7, 2023
Thailand is a member state of the ASEAN Economic Community, and next year, it is expected that the ASEAN Harmonization of Traditional Medicines and Health Supplements will be signed by the economic minister of each ASEAN country. Following ratification, the ASEAN Guidelines on Claims and Claims Substantiation for Traditional Medicines and Health Supplements will become the standard guidelines in the region, and various implementation efforts and instruments will follow. These guidelines cover a wide range of medicines and supplements; however, it is not possible to cover all herbal products. There are three types of health supplement claims: nutritional claims, functional claims, and disease risk reduction claims. Examples of the three types of claims include the following: Nutritional claims: supplements nutrition, nourishes the body, supports healthy growth and development, etc. Functional claims: maintains healthy joints, supports immunity, maintains liver function, etc. Disease risk reduction claims: helps to reduce risk of dyslipidemia, helps to reduce risk of osteoporosis, etc. The degree of evidence required for substantiating disease risk reduction claims is higher than for functional claims and nutritional claims. Functional claims and disease risk reduction claims must be substantiated by efficacy studies and the relevant toxicity data. It is the responsibility of the health supplement company to provide the required evidence in order to comply with the criteria for making such claims. Tips on Health Claims for Health Supplements 1. Nutritional Claims For essential nutrients such as vitamins and minerals, as listed by the Thai Food and Drug Administration (FDA), the amount included in a supplement must be between 15% and 100% of the Thai Recommended Daily Intake (RDI) values. Rules for specific kinds of nutritional claims are provided in the Notification of the Thai FDA RE: Nutrient Function Claims. For example, the nutrients that can be claimed as boosting the
Read More
August 29, 2023
Laos’ Ministry of Health (MOH) has promulgated a regulation detailing registration and notification protocols for medical devices. Decision on the Registration and Notification of Medical Devices No. 1470/MOH will come into force 60 days after both the signing of the regulation (which already occurred in July) and publication in the Official Gazette, which has not yet been specified by the government. Registration of medical devices in Laos is mentioned in the country’s Law on Drugs and Medical Products No. 07/NA, dated December 21, 2011, but a registration procedure has not been put in place. There was only a separate requirement to furnish certain required documents when importing medical devices. Now, the decision outlines the registration and notification process for medical devices through the Ministry of Health’s Food and Drug Department (FDD), in line with the regulatory principles in the ASEAN Medical Device Directive of 2015, which Laos has ratified. Medical Devices in Laos The decision defines medical devices as any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material, or other similar or related article intended for any of the following uses in humans: Diagnosis, prevention, monitoring, recovery from, or alleviation or treatment of a disease; Diagnosis, monitoring, recovery from, or alleviation of or compensation for an injury; Replacement, modification, or support of anatomy or a physiological process; Supporting and sustaining life; Controlling or assisting in conception; or Disinfection and sterilization of tools and medical devices. Medical devices in Laos are given one of four classifications based on their level of risk: Class A – Low risk (e.g., rubber belts, cotton for medical purposes, nonwoven swabs, adhesive bandages) Class B – Low-moderate risk (e.g., neonatal suction equipment, surgical gloves, gastro-catheters) Class C – Moderate-high risk (e.g., endoscopic surgical equipment, anesthesia equipment, peritoneal dialysis equipment) Class
Read More