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

June 11, 2024

Genome Editing in Thai and Indonesian Agricultural Biotechnology

Subscribe to Updates

Advances in biotechnology have enabled the development of a range of new agricultural tools. From DNA sequencing to plant tissue culture and gene editing, these advances are facilitating the development of better crops.

Genetically modified organisms (GMOs) are one well-known example of agricultural biotechnology. GMOs are organisms whose genetic material has been artificially altered by inserting a piece of foreign DNA. This DNA may be synthetic in origin or sourced from other organisms.

Genome editing (also called gene editing or GEd) involves making precise changes to an organism’s genome without the integration of foreign DNA elements. Several approaches to genome editing have been developed. A well-known one is called CRISPR-Cas9, in which scientists make precise “cuts” in the DNA to create a new genetic variation. Unlike with GMOs, this introduces only minor modifications that are indistinguishable from natural mutations, typically by transplanting genes that code desirable traits from one species into another.

GEd technology has been recognized and supported by the Food and Agriculture Organization of the United Nations (FAO). Thirteen FAO-member countries who are also members of the Organization for Economic Cooperation and Development (OECD) announced their support of the use of GEd technology for commercial uses and consumption at a recent WTO meeting. In addition, over 40 countries around the world, such as Argentina, Australia, Brazil, Canada, Chile, China, England, Japan, Kenya, the Philippines, Russia, the UK, and the US, have published policies emphasizing that foods free of transgenes (i.e., foods that do not contain genes transferred from external sources) are not GMOs, concluding that GEd plants are as safe as normal plants.

In February 2024, the European Parliament approved new genomic techniques (NGTs), or GEd. As a result, plants that are produced using GEd technology are not classified by the EU as GMOs, and the EU authorities consider them to be the same as conventional plants.

Thailand’s Stance toward GEd

In Thailand, the Department of Agriculture in the Ministry of Agriculture and Cooperatives (MOAC) views the results of the EU vote as providing timely support for Thailand’s own policy consideration of the issue. The European Parliament has agreed that genome editing technology is highly safe for human health and the environment, and its use can potentially reduce costs and increase the quality and productivity of agriculture. With this development, it is an opportune time for Thailand to accelerate the process of adopting GEd technology in the agricultural sector for food safety and security by drafting guidelines for the application of GEd technology.

Since the beginning of 2024, the MOAC has taken several actions targeting the development of GEd knowledge.

One event the Department of Agriculture organized was a seminar titled “Modern Biotechnology to Solve the Global Crisis and Emerging Pests.” This event was a brainstorming seminar for all stakeholders on how to take advantage of technology that is safe and on par with other countries, as well as creating guidelines for operating and driving GEd technology in Thailand, including communicating with the public and consumers for a better understanding of the safety of GEd technology and its difference from the production of GMOs. The seminar emphasized that Thailand must be able to take advantage of GEd technology in its future planning for addressing global crises and emerging pests that will impact its agricultural sector.

The Department of Agriculture also organized an academic seminar on GEd technology to set a clear national stance on the issue and accelerate communication with the public and consumers that plants produced with GEd technology are different from GMOs. Next, the Department of Agriculture will invite experts from the FAO, from various countries such as Australia, Japan, and the United States, and from the private and public sectors to join together in a push to build confidence in GEd technology and speed up the preparation of operational procedures. Doing so will assist Thailand in leveraging genome editing technology for the agricultural sector for food safety and security through modern biotechnology. The experts mentioned above recognize that NGTs, or GEd, are likely to continue playing an important role in the increasingly dire situations of global warming and global food crises.

Most professionals believe that using GEd technology to modify the genetics of groups of plants that can be naturally hybridized can produce high-yielding plant varieties that are resistant to disease and drought. In addition, they believe that GEd technology will increase nutritional value. Most countries in the world have invested in research into GEd and approved the use of GEd technology, accepting GEd technology for both commercial and consumption purposes, as with conventional crops, to increase national food security.

Early Support for GEd in Thailand

Though the Ministry of Agriculture and Cooperatives in Thailand has not yet issued any draft notifications or announced public hearings regarding the use of GEd, there is progress in the public sector. One project showing that Thailand is ready to support the use of GEd technology was launched when the National Center for Genetic Engineering and Biotechnology (BIOTEC) released a publication looking at the issue of genome editing and providing technical criteria for considering organisms developed with GEd technology.

Under the guidelines, genome-edited plants derived from the use of GEd techniques employing site-directed nucleases (SDNs) are generally classified into three categories:

  • SDN-1 (deletion), site-directed mutagenesis without using a DNA sequence template.;
  • SDN-2 (substitution), site-directed mutagenesis using a DNA sequence template.; and
  • SDN-3 (insertion), site-directed insertion of a gene/large DNA sequence using a DNA sequence template.

The guidelines have not set out criteria for considering organisms developed with genome-editing technology that do not qualify as living beings genetically modified.

In the view of BIOTEC, SDN-1 plants are not considered to be GMOs, while SDN-2 and SDN-3 plants may be considered as such. If a party wishes to use GEd in conjunction with food, a safety assessment by BIOTEC will be required. The required safety assessment for SDN-1 is lower than for SDN-2 and SDN-3.

This is a positive sign showing that Thailand is ready to move forward with GEd technology development. We may see wider discussions, acceptance, and regulations regarding GEd technology in the future.

Indonesia’s Stance toward GEd

In recent discussions on GEd technology, Indonesian authorities agreed that the determination of whether or not genome-edited products are considered genetically modified will be based on the mechanism of genetic repair, in accordance with the definitions set forth in the Cartagena Protocol and Government Regulation No. 21 of 2005 regarding Biosafety of Genetically Modified Products. If the repair mechanism is carried out by involving donors or genes that do not have a taxonomic relationship with the organism that is the subject of the GEd, the genome-edited product is considered genetically modified. However, if it does not involve a donor or genes outside the individual, it can be considered non-genetically modified.

Despite the discussions surrounding genome editing, there are not yet any specific regulations on genome editing in Indonesia. Therefore, based on Government Regulation No. 21 of 2005 regarding Biosafety of Genetically Modified Products, GEd is still considered genetic modification, and genome-edited products must undergo a safety assessment in order to obtain approval from the Biosafety Commission.

The safety assessment procedure for genetically modified food products is overseen by Indonesia’s National Agency of Drug and Food Control, or BPOM, and involves the following steps:

  • Application submission. Applications are submitted through BPOM’s e-filing system. Applicants must also submit supporting documents in accordance with the relevant BPOM regulations regarding genetically modified food products, accompanied by an integrity pact.
  • Data verification process. If the application is not complete, the applicant must supply the required materials within 14 days of receiving notification from the head of BPOM.
  • Biosafety commission assignment. The head of BPOM assigns the Biosafety Commission to conduct a food safety assessment. The Biosafety Commission has the task of providing recommendations to the authorized minister and the head of the authorized non-ministerial government institution (LPNK) in formulating and establishing policies and issuing biosafety certificates for genetically modified products.
  • Assessment by Biosafety Commission. The Biosafety Commission conducts the food safety assessment within 14 days.
  • Assessment by Biosafety Technical Team. The Biosafety Commission may assign the Biosafety Technical Team, which assists the Biosafety Commission in conducting evaluations and technical assessments of biosafety, to conduct a technical document review and perform further testing if necessary. This will be completed within 56 days of receiving the assignment letter from the Biosafety Commission.
  • Technical assessment results. The Biosafety Technical Team submits the results of the technical assessment to the Biosafety Commission within 7 days.
  • Assessment submission to Biosafety Clearing House. The Biosafety Commission submits the technical assessment of the Biosafety Technical Team to the Biosafety Clearing House, a Biosafety Commission tool that serves as a means of communication between the Biosafety Commission and stakeholders, within 15 days.
  • Publication by Biosafety Clearing House. The Biosafety Clearing House publishes a summary of the Biosafety Technical Team’s technical assessment for 60 days to allow the public to comment.
  • Report submission to Biosafety Commission. The Biosafety Clearing House then submits a public response report to the Biosafety Commission.
  • Biosafety Commission recommendation. The Biosafety Commission submits a food safety recommendation to the head of BPOM within 14 days. In submitting recommendations on food safety of Genetically Modified Products to the Head BPOM, taking into account the results of the assessment of the Biosafety Commission Technical Team and input from the public.
  • Issuance of approval by Head of BPOM. The head of BPOM issues a safety certificate and permit for the distribution of the genetically modified food.

Conclusion

As the regulatory landscapes continue to evolve around genome editing technologies in Thailand, Indonesia, and across the globe, businesses operating in the agricultural biotechnology sector must stay vigilant. Navigating the emerging regulations and approval processes will be crucial for companies looking to commercialize new genome-edited crops and food products. Companies must also carefully manage public perception around genome editing, clearly communicating the science and safety assessments behind these innovations. With strategic foresight and regulatory attentiveness, the agricultural biotech industry can capitalize on the promise of genome editing to enhance food security and drive sustainable productivity gains. Businesses primed to leverage genome editing technologies while mitigating regulatory risks will be positioned for leadership in this new age of agricultural biotechnology.

Related Professionals

Industries

Life Sciences

Practices

Regulatory Affairs

Locations

RELATED INSIGHTS​ 

August 8, 2025
In response to persistent challenges in food safety management and recent high-profile incidents involving counterfeit supplemented foods, infant formula, and health supplements, the Ministry of Health of Vietnam is initiating comprehensive regulatory reforms. These reforms include proposed amendments to the Law on Food Safety and its implementing Decree No. 15/2018/ND-CP (Decree 15), introducing significant changes to the registration procedures for food products, especially supplemented food products and health supplements. While awaiting public consultation and approval of the amended Law on Food Safety, the Ministry of Health is developing an interim mechanism, which includes a draft decree to replace Decree 15 and a draft resolution to address urgent issues until the amended law becomes effective, expected in July 2026. To align with the new Law on Quality of Products and Goods, the draft resolution stipulates that the declaration and registration of food products will follow the following procedures: Declaration of applied standards for food products, which is currently known as the “self-declaration” procedure, applies to processed packaged foods, food additives, food processing aids, containers or utensils that come into direct contact with food, packaging materials in direct contact with food, and micronutrients. Granting of circulation numbers, which is the current “registration of product declaration” procedure, applies to specific categories of food including health supplements, medical nutrition foods, special dietary foods, nutritional products for children up to 36 months, and, especially, supplemented foods, which are currently subject to self-declaration but will be shifted to this registration procedure. In addition, the following new procedure is introduced in the draft decree: Registration of declaration of conformity, which applies to the same product category as in “declaration of applied standards” above, but is for products that are already subject to technical regulations covering both safety indicators and quality indicators. Changes to the Food Product
Read More
July 23, 2025
On June 26, 2025, the National Assembly of Vietnam adopted Resolution No. 216/2025/QH15 to extend the duration of agricultural land use tax exemption through December 31, 2030. This policy extension reaffirms the government’s ongoing efforts to support the agricultural sector, ensure national food security, and promote rural development. Key Takeaways Tax Exemption Period Extended: The new resolution continues the full exemption from agricultural land use tax as stipulated under Resolution No. 55/2010/QH12, as amended in 2016 and 2020. The tax exemption, which was originally set to expire at the end of 2025, will now remain in effect until December 31, 2030. Scope of Exemption: The exemption applies to all types of land currently eligible under the existing legal framework for agricultural land use tax relief. This typically includes land used by households, cooperatives, and non-commercial organizations for agricultural production, aquaculture, salt-making, and reforestation. Effective Date: Resolution 216 will take effect on January 1, 2026. During the interim period, tax exemption remains valid under existing laws and resolutions until the end of 2025. Implementation Guidance to Follow: The government is tasked with issuing detailed guidance to ensure effective implementation of this extended exemption. Businesses, cooperatives, and individuals engaged in agricultural activities should monitor upcoming regulations and instructions from relevant ministries. Outlook Vietnam’s extension of agricultural land use tax exemption demonstrates a strong policy commitment to rural economic stability and environmental sustainability. For land users, the exemption represents meaningful financial relief that can be reinvested into modernizing farming techniques, improving land efficiency, or transitioning to sustainable practices. While the extension itself is automatic, it is recommended that agricultural land users and stakeholders review their land use documentation and tax profiles to ensure alignment with eligibility requirements. Future implementation regulations may also introduce new compliance obligations that should be tracked closely.
Read More
July 15, 2025
On July 1, 2025, Vietnam’s Ministry of Health issued Circular No. 30/2025/TT-BYT providing updated guidance on the application of drug quality standards, testing of drugs and pharmaceutical ingredients, and procedures for the recall and handling of noncompliant drugs (Circular 30). Circular 30 officially came into effect on the same day and replaces Circular No. 11/2018/TT-BYT and its amendments. Key highlights of Circular 30 are presented below. Drug and Pharmaceutical Ingredient Quality Standards Circular 30 maintains consistency with previous regulations regarding the selection of an applicable quality specification. Pharmaceutical businesses and drug preparation establishments may still choose to apply standards from the Vietnamese Pharmacopoeia, reference pharmacopoeias (including the United States Pharmacopoeia, the European Pharmacopoeia, the British Pharmacopoeia, the Japanese Pharmacopoeia, and the International Pharmacopoeia), or an in-house specification. Priority is given to the Vietnamese Pharmacopoeia and reference pharmacopoeias, encompassing quality indicators, quality levels, and testing methods. If alternative pharmacopoeias or in-house specifications are used, they must meet the requirements outlined in the corresponding monographs of the Vietnamese or reference pharmacopoeias. At the time of registration, the quality standards of drugs and pharmaceutical ingredients must comply with either the current version of the pharmacopoeia or a previous version of the pharmacopoeia that is no more than two years older than the current version. The requirement for updating quality specifications in line with the quality under the corresponding pharmacopoeia also applies to products that have already been granted marketing authorization. Testing Drugs and Pharmaceutical Ingredients in Quality Management Similar to the regulations under the previous circular, if pharmaceutical businesses disagree with the sample testing results, they may, within five working days of receiving the test report, request that the state quality inspection authority designate an alternative testing facility. The testing period for establishments listed as foreign drug manufacturers with quality violations remains
Read More
July 14, 2025
Life sciences specialists from Tilleke & Gibbins have updated the firm’s guide to pharmaceutical data exclusivity regulations and practices in Southeast Asia. This guide contains quick-reference information on the availability of data exclusivity protections and limitations in Cambodia, Indonesia, Laos, Malaysia, Myanmar, Thailand, and Vietnam. Developing and launching a new drug on a commercial scale requires an enormous amount of time and investment in research and development (R&D), including pre-clinical testing and clinical trials. When considering the aggregate amount of drug development costs, it is important to recognize that this includes not only the investment in developing new drugs that get approved by a government food and drug regulator and are successfully brought to market, but also the R&D expenditures on a large number of potential pharmaceutical compounds and products that never actually make it to market. In particular, considerable investment is required in order to conduct and produce clinical trial data—to prove safety, efficacy and effectiveness of a new drug—that would warrant marketing approval by the regulatory authority. Such data is proprietary in nature and highly valuable for a research-based pharmaceutical company that develops an original drug. On the other hand, patent law typically confers generic drug manufacturers with the ability to engage in various preparatory activities with a view to obtaining marketing approval for a generic product before the patent for the original drug expires (commonly known as a “Bolar provision”). Since a generic drug maker may submit an application for marketing approval of a generic product before the relevant patent expires, the extent to which the drug originator’s data submitted to the regulatory authority is protected—or in other words, the extent to which the generic company may rely on the drug originator’s previously filed data, which underpins the safety and efficacy of the drug, to support
Read More