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

March 7, 2025

Laos’ New Regulation on Biopharmaceuticals, Gene Therapy, and Stem Cells

Subscribe to Updates

On November 22, 2024, the Ministry of Health (MOH) in Laos issued Decision No. 3730/MOH, which regulates the management, processing, production, and use of biopharmaceutical products, genes, and stem cells. This decision came into force on January 18, 2025, 45 days after its publication in the Lao Official Gazette on December 4, 2024. This decision signifies Laos’ recognition and acceptance of biopharmaceutical products, genes, and stem cells for use in medical treatments and the beauty industry, and it aligns with the ongoing development of biomedical sciences in the country.

Definitions

The MOH’s decision defines biopharmaceuticals, gene therapy, and stem cells as follows:

  • “Biopharmaceutical products” refers to a type of biological or drug product that is produced or synthesized from natural substances, objects, or chemicals. This group of products includes blood, blood components, allergens, cells or cellular components, gene therapies, tissues, protein-based medicines, drugs derived from living cells, and biologics, which can be produced from sugars, proteins, amino acids, or substances with complex characteristics derived from organic sources such as human, animal, and plant parts; yeast; and microorganisms. These products exclude vaccines and biosimilar products, which will be specified under separate regulations.
  • “Gene therapy” refers to a treatment approach that applies the principle of arranging amino acids (which could involve DNA or RNA sent to the patient’s cells in the form of a drug with the purpose of treating a certain disease).
  • “Stem cells” are defined in the decision as cells or immature cells that can be sourced from various organs in the They are characterized by being undifferentiated, having the potential for differentiation, and being self-renewing.

Stem Cell Production

The decision outlines comprehensive provisions for managing and using raw materials in stem cell production. Key points include:

  • Production location standards: Ensuring facilities meet specific standards of the MOH.
  • Personnel nationality restrictions: Limiting certain roles to Lao nationals—for instance, product managers, quality control managers, and quality assurance managers.
  • Raw material requirements: Complying with ethics committee guidelines, including prohibitions on using embryos and fetuses.
  • Product consent agreement: Before using certain types of stem cell products on a patient, consent must be obtained from a fully conscious patient and witnessed by a relative. If a patient is unconscious, consent for treatment or services must be obtained from a relative in accordance with ethical guidelines.
  • Compensation for damages resulting from use: The consent form for treatment must specify the conditions for compensation for damages resulting from the use of the product in accordance with the treatment conditions set out in the consent form.

Importation and Exportation

For importing biopharmaceutical products, genetic material, and stem cells, applicants must submit complete documentation, including an enterprise registration certificate, production license, and product quality certificate. Strict quality inspections and compliance with the Law on Drugs and Medical Products are mandatory. Additionally, the importation of raw materials from embryos and fetuses is prohibited.

Exporters must also provide comprehensive documentation, including an exportation approval certificate, product registration certificate, and quality inspection report. They must ensure product quality through rigorous inspections and comply with both local and destination country regulations.

Clinical Trial Management

This decision defines a clinical trial as “a scientific process that designs and conducts experiments on the human body. The interpretation of the research results aims to provide an understanding of the principles and guidelines for the use of drugs, devices, instruments, and procedures in treating patients.” Clinical trials must be authorized by the MOH’s Food and Drug Department (FDD) through the approval of an ethics committee. All procedures, processes, and actions related to the clinical trial must be approved by the FDD, which will approve the conduct of a clinical trial if it is assessed to be beneficial for the development of disease prevention and treatment in Laos.

Business Operating Requirements

To operate a business involving stem cells, operators must:

  • Obtain licenses from relevant sectors, including planning and investment, natural resources and environment, and health.
  • Be Lao nationals with relevant qualifications.
  • Undergo regular inspections and evaluations by the MOH.
  • Employ specialists with appropriate qualifications and experience.

Businesses operating in the biopharmaceutical, gene therapy, and stem cell sectors in Laos must navigate a complex regulatory landscape under Decision No. 3730/MOH. The decision establishes clear compliance requirements, from facility standards and personnel restrictions to ethical sourcing and quality control. Companies seeking to enter or expand in this market should closely monitor further regulatory developments and ensure strict adherence to MOH guidelines. As Laos continues to develop its biomedical sector, businesses that align with these regulations and invest in compliance infrastructure will be well-positioned for long-term growth and market stability.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Location

RELATED INSIGHTS​ 

May 28, 2025
Thailand’s Food and Drug Administration (FDA) has launched a strategic collaboration with leading e-commerce platforms Lazada and Shopee to strengthen regulatory oversight of health-related products sold online. This partnership is part of a broader initiative to enhance consumer protection, enforce compliance with Thai health regulations, and foster a safer digital marketplace for health products. As part of this initiative, the Thai FDA is urging all sellers—particularly cross-border vendors—to secure proper FDA registration for their products before market entry. The objective is to ensure that only legally authorized, safe, and quality-assured healthcare products are available to Thai consumers. In pursuit of this goal, the FDA has been working closely with Lazada and Shopee to implement proactive surveillance mechanisms aimed at identifying and removing noncompliant, substandard, or unregistered products. This collaboration has already yielded measurable results. Between September 2023 and 2024, Lazada supported regulatory enforcement by removing 9,454 noncompliant listings and delisting 30 vendors. In addition, 134 sellers were subjected to legal proceedings for regulatory violations. Shopee has taken a similarly rigorous stance, committing to the immediate removal of products found to be in breach of FDA regulations. The platform has also provided educational materials for merchants and implemented consumer complaint mechanisms to enhance accountability. Looking ahead, the Thai FDA plans to roll out a data integration system utilizing API technology, enabling seamless and secure exchange of regulatory data between the agency and e-commerce platforms. This system will be supported by comprehensive training for both Thai FDA officials and e-commerce staff, with a particular focus on the use of the Thai government’s Law Enforcement Request Portal, a secure communication channel for coordinating enforcement actions between government agencies and platform operators. Additionally, a joint product inspection framework is currently under development in partnership with Lazada and Shopee. This framework will incorporate strict
Read More
May 27, 2025
On May 16, 2025, Vietnam’s Ministry of Health (MOH) issued Circular No. 12/2025/TT-BYT on registration of drugs and drug materials (Circular 12). Circular 12 will come into effect on July 1, 2025, replacing Circular No. 08/2022/TT-BYT (as amended), which provides the current regulations on drug registration, along with Circular No. 16/2023/TT-BYT on registration of drugs under toll manufacturing and technology transfer, and Circular No. 07/2017/TT promulgating the list of non-prescription drugs. Some of the key stipulations of Circular 12 are outlined below. Regulation of non-prescription drugs Circular 12 abolishes the detailed list of over-the-counter (OTC) drugs previously stipulated in Circular No. 07/2017/TT-BYT. Instead of relying on a fixed list for classification, Circular 12 introduces a new framework based on principles, criteria, and specific methods for determining the status of non-prescription/OTC drugs. This approach aims to enhance safety, ensure timely access, reflect actual usage and supply conditions, and align with international standards. Drugs that have already been approved will retain their classification (i.e., as prescription or non-prescription) throughout the validity of their marketing authorization (MA), and reclassification will be considered when the MA is renewed. If a change in classification is requested, the MA holder must submit a variation registration dossier to the Drug Administration of Vietnam (DAV). For drug registration dossiers currently under evaluation by the DAV, the classification will be assessed in accordance with the new provisions set out in Circular 12. Drug registration The new regulations under Circular 12 loosen the requirements on providing a Certificate of Pharmaceutical Product (CPP). For all drug registration cases, a single CPP will suffice, provided it is issued by the competent authority of the manufacturing country or by an authority from a country that is a member of the European Medicines Agency (EMA) or a Stringent Regulatory Authority (SRA), and confirms
Read More
May 15, 2025
Vietnam’s Ministry of Health (MOH) has published for public consultation a draft amendment of the Law on Donation, Recovery, and Transplantation of Human Tissues and Organs and Donation and Retrieval of Cadavers, a law which has been in effect since 2007. Among its changes, the draft amendment notably includes new provisions on stem cells, a hot-button topic with social, legal, and ethical ramifications extending beyond the medical field. There are currently no specific regulations on stem cells under Vietnamese law—only the MOH’s technical guidance—leaving many controversial issues unsettled. Key points related to stem cells that may impact the activities of researchers and institutions in Vietnam and abroad are highlighted below. Requirements for Stem Cells Under the draft amendment, stem cells are defined as cells naturally occurring in the body, having the ability to divide and differentiate into various types of cells. The draft amendment outlines conditions for stem cell donation, establishes requirements for medical facilities authorized to receive stem cell donations, and specifies the rights of stem cell donors. Under the draft amendment, it is prohibited to receive, screen, or produce stem cells at facilities that do not satisfy conditions. Establishment of Private Stem Cell Banks In addition to state-owned stem cell banks, the draft amendment also addresses independent stem cell banks established by private investors. In general, the stem cell banks (whether public or private) must obtain an operation license by meeting various conditions on personnel, equipment, facilities, and management systems to be further guided by the government. Notably, stem cell banks will have the right to cooperate with foreign entities in exchanging stem cells for treatment, education, and research purposes. Prohibition on Creating Embryos for Stem Cell Research or Therapy Considering the ethical concerns over the use and destruction of embryos, the draft amendment expressly prohibits the
Read More
May 2, 2025
Attorneys from Tilleke & Gibbins have updated the latest edition of Doing Business in Thailand, a Q&A-style guide from Thomson Reuters Practical Law that offers an overview of key legal considerations for companies operating in jurisdictions worldwide. The contribution outlines the country’s legal and regulatory framework for foreign investment and business operations and reflects the latest legislative developments. The chapter addresses the following core topics: Legal system: Structure of the courts and the codified nature of Thai law. Foreign investment: Business restrictions under the Foreign Business Act, sector-specific regulations, exchange control rules, and investment incentives. Business vehicles: Overview of partnerships, private and public limited companies, and other legal entities. Employment: Labor protections, employment contracts, foreign worker requirements, and termination procedures. Tax: Corporate and personal income tax, indirect taxes, and tax obligations for residents and non-residents. Intellectual property: Registration and enforcement of patents, trademarks, designs, and copyrights. Data protection: Key provisions of the Personal Data Protection Act and related compliance obligations. Competition law: Regulatory framework under the Trade Competition Act. Anti-bribery and corruption: Relevant legislation and enforcement mechanisms. E-commerce and digital business: Legal regime for online transactions and digital platforms. Marketing and advertising: Consumer protection laws and regulations affecting advertising and marketing practices. Product regulation and liability: Safety standards, liability regimes, and roles of enforcement authorities. Practical Law, a legal reference resource from Thomson Reuters, publishes a range of guides for hundreds of jurisdictions and practice areas. The insurance and reinsurance guide is a valuable resource for legal practitioners, covering numerous jurisdictions worldwide. To view the latest version of the guide, please visit the Practical Law website and enroll in the free Practical Law trial to gain full access.
Read More