Malaysia's national biosafety framework is robust and well-established, anchored by the Biosafety Act 2007, which entered into force in 2009. This Act provides the legal authority to regulate the release, importation, and contained use of Living Modified Organisms (LMOs) and their products. The Act is operationalized through a suite of subsidiary legislation, including the Biosafety (Approval and Notification) Regulations 2010. To further strengthen enforcement and compliance, two additional regulations were gazetted in 2018: the Biosafety (Sampling Procedures) Regulations 2018, which standardizes sampling for enforcement purposes, and the Biosafety (Compounding of Offences) Regulations 2018, which provides a mechanism for addressing non-compliance. These legal instruments are complemented by a series of biosafety guidelines that provide technical details for implementation

Malaysia maintains a dedicated institutional structure for biosafety, with the Department of Biosafety serving as the competent national authority and secretariat to the National Biosafety Board (NBB) and the Genetic Modification Advisory Committee (GMAC). While a core of more than 10 permanent, qualified staff administers biosafety functions, this number is considered inadequate to fully address the expanding scope and complexity of the field. The rapid evolution of biotechnology, including new breeding techniques, and the increasing volume of LMOs in trade necessitate continuous capacity enhancement. Recognizing this gap, Malaysia has actively sought to strengthen its human and institutional resources through targeted initiatives, most notably the Global Environment Facility (GEF) supported project "Institutional Capacity to Enhance Biosafety Practices in Malaysia," which focuses on building technical expertise and strengthening the overall management system

The Biosafety Act 2007 and its regulations provide a clear framework for LMOs which are pharmaceuticals. The Biosafety (Approval and Notification) Regulations 2010 exempt pharmaceutical products of LMOs from the Act's approval and notification requirements if they are already addressed by other relevant international treaties or regulated under other national laws pertaining to pharmaceuticals. This prevents regulatory duplication. However, the local production of human and animal pharmaceutical products using LMOs remains fully regulated under the Biosafety Act 2007. The clinical trial phases for such products are overseen by specialized agencies: the National Pharmaceutical Regulatory Agency (NPRA) for human pharmaceuticals and the Department of Veterinary Services (DVS) for animal pharmaceuticals, ensuring that expert oversight is applied at each stage of development and use. NPRA and DVS have been appointed as Competent National Authority in Malaysia.

Contained use of LMOs is comprehensively regulated under the Biosafety Act 2007. The legislation defines "contained use" as any operation involving LMOs within a physical structure that prevents their contact with and impact on the external environment. This includes research and development, manufacturing, and storage. The regulations specify four Biosafety Containment Levels (BSL), consistent with international standards, which dictate the minimum containment requirements. The appropriate BSL for any given activity is determined through a mandatory risk assessment. Detailed technical guidance on facility specifications and work practices for each containment level is provided in the Biosafety Guidelines for Contained Use Activity of Living Modified Organism. Again, it has to be reemphasised, any LMO’s entering Malaysia has to be referred to National Biosafety Board for approval.

Malaysia has a fully operational legal framework (Biosafety Act 2007) to manage the AIA procedure as stipulated in the Protocol. This Biosafety Act 2007 requires any person intending to export an LMO to notify the National Biosafety Board (NBB) and comply with the requirements of the importing Party. Legal provisions are also in place to ensure the accuracy of the information provided in such notifications. However, during the current reporting period (2020-2026), Malaysia has not received any notifications for the import of LMOs for intentional introduction into the environment. Consequently, no decisions under the AIA procedure were taken. The national framework is prepared to apply the precautionary approach in cases of scientific uncertainty regarding potential adverse effects, ensuring that any decision-making process would be rigorous and prioritise the protection of biodiversity and human health.

The Biosafety Act 2007 defines placing LMOs or product of LMOs on the market as a "release activity," which requires prior approval from the National Biosafety Board (being advised by a technical committee called Genetic Modification Advisory Committee - GMAC). This applies to both imported and locally developed LMOs and product of LMOs to be used for FFP. The established regulatory framework ensures that all approvals are based on a scientific risk assessment, with measures in place to address any scientific uncertainty, relevant policy consideration and taking into consideration public consultation. The Biosafety Act 2007 also provides a provision to take socio economic consideration for decision making if necessary

The Biosafety Act 2007 provides a clear mechanism for the review of decisions. The National Biosafety Board, in consultation with GMAC, can review any approval at any time if new scientific information emerges regarding risks to human health, plant and animal health, the environment, or biodiversity. Depending on the re-assessment of risk, the National Biosafety Board has the authority to revoke an approval, issue a cessation order, or impose additional conditions. The framework also allows an aggrieved applicant to appeal a decision to the Minister. During this reporting period, no new scientific evidence has necessitated the review or change of any prior decisions regarding intentional transboundary movements.

Malaysia has implemented simplified procedures through specific exemptions granted under the Biosafety Act 2007. These measures are designed to reduce administrative burden without compromising safety. Key examples include: An exemption for the subsequent use of an approved LMO-FFP. Once an LMO event is approved for food, feed, or processing, any other person using it for the same purpose is exempted from submitting application. An exemption for repeat exports. An exporter sending the same LMO to the same country for the same purpose only needs to submit a notification once. Subsequent exports do not require further notification. These procedures have been applied during the reporting period, and all relevant information has been made available to Parties through the Biosafety Clearing-House (BCH).

During the reporting period, Malaysia has not entered into any new bilateral, regional, or multilateral agreements or arrangements specifically concerning the transboundary movement of LMOs as per Article 14. Cooperation on biosafety matters continues through participation in regional and international forums and workshops.

A significant evolution in Malaysia's regulatory approach has been its proactive stance on new breeding techniques. Previously, the nation identified a need for guidance in this area. In response, a policy decision was made to exempt SDN-1 gene-edited organisms, which do not contain foreign DNA, from the full scope of GMO regulations. This demonstrates a shift towards a more product-based and risk-proportionate regulatory philosophy, reflecting the growing scientific capacity to make nuanced distinctions between different biotechnologies. Capacity in monitoring, previously identified as a weakness, has been strengthened. The answer to question 69(d) has been upgraded from "No" in the 4th report to "Yes, to some extent." This improvement is a direct result of capacity-building activities under the GEF project and enhanced inter-agency coordination for enforcement and monitoring, through strategic partnership with Ministry of Health (MOH), Royal Malaysian Customs Department, Malaysian Quarantine and Inspection Services (MAQIS), Department of Veterinary Services (DVS), Department of Agriculture (DOA) and the most recent partnership with Malaysian Border Control and Protection Agency (AKPS). While training in risk assessment, management, and monitoring continues for a large number of personnel, the numbers are still considered inadequate to meet the demands of a rapidly advancing field, justifying continued investment in capacity building.

Malaysia has established measures for notification and response in the event of an unintentional transboundary movement. During the reporting period, there were no such occurrences. The nation's capacity to prevent and respond to such events has been significantly enhanced. The strategic partnership established with the Malaysian Border Control and Protection Agency (AKPS) strengthens the surveillance and control measures at all national entry points, serving as a key preventive mechanism against unintentional movements. In the event of a release, Malaysia can adapt existing emergency response plans, such as those developed for invasive alien species, to manage LMO-related incidents effectively.

Malaysia has made significant strides in strengthening the implementation of Article 18. The legal framework requires appropriate handling, packaging, and documentation for all categories of LMOs. A key development has been the enhancement of enforcement capacity at the border, which was previously identified as a structural weakness. The formal strategic partnership with the Malaysian Border Control and Protection Agency (AKPS) provides a more dedicated and integrated enforcement capability at entry points, representing a significant upgrade from previous arrangements that relied on coordination between different agencies. This partnership directly addresses a gap where Royal Malaysian Customs was not involved in LMO identification. Targeted training programs for officers from AKPS and MAQIS have been conducted to improve the identification of LMOs and enforcement of documentation requirements. The Biosafety (Sampling Procedures) Regulations 2018 provide a clear legal basis for sampling. Malaysia has a network of laboratories capable of LMO detection and identification, with the Department of Chemistry Malaysia serving as the designated accredited analyst for enforcement purposes, supported by other institutions like the Forest Research Institute of Malaysia and the National Public Health Laboratory. These combined efforts have elevated the national capacity to enforce Article 18 requirements from "to some extent" to a more robust and operational level

Malaysia's institutional framework for biosafety is mature and clearly defined. The Ministry of Natural Resources and Environmental Sustainability serves as the National Focal Point for the Protocol. The Department of Biosafety is the competent national authority. It is supported by the National Biosafety Board as the decision-making body and the Genetic Modification Advisory Committee (GMAC) for scientific and technical advice. The focus during this reporting period has been on reinforcing the effectiveness of this structure through enhanced collaboration. The strategic partnership with AKPS is a prime example of this strategy, moving beyond ad-hoc coordination to create a structured, operational framework for border control. This initiative directly strengthens the implementation and enforcement capacity of the competent national authority, demonstrating a strategic shift from establishing institutions to optimizing their operational effectiveness.

Decisions regarding the import of LMOs for contained use are not made publicly available in the BCH due to requests from stakeholders. These activities are predominantly for research and development or for commercial production processes where proprietary information is involved. To protect intellectual property and commercial interests, these decisions are held by the competent authority but not published publicly. Similarly, summaries of risk assessments are only partially available for the same confidentiality reasons

Malaysia continues to prioritize providing stakeholders and the public with a reliable reference point for biosafety information to build confidence, ensure transparency, and facilitate open communication. In accordance with Article 20, Malaysia actively updates the national Biosafety Clearing House (BCH) and maintains the official Department of Biosafety website (www.biosafety.gov.my) as the primary avenue for information dissemination. A significant advancement during this reporting period is the development of a formal 'Biosafety Communication Framework' under the GEF-supported capacity-building project (ID: 9111). This initiative moves the nation beyond ad-hoc outreach to a structured, strategic approach for information sharing and public engagement. The Department of Biosafety actively utilizes social media platforms to disseminate real-time information and activities. Furthermore, information sharing has been bolstered by high-level events such as the Biosafety Symposium 2025, which served as a key platform for national and international dialogue. These efforts ensure that accurate, unbiased information regarding the Biosafety Act 2007 and the Protocol reaches all stakeholders, from local research institutes to the general public.

The protection of confidential business information is explicitly provided for under the Biosafety Act 2007. Applicants are required to identify which parts of their submission should be treated as confidential. The handling of such information is governed by the Official Secrets Act 1972, ensuring a high level of protection. This provision is crucial for fostering trust with the private sector and encouraging innovation, while being consistent with international trade obligations.

Malaysia places strong emphasis on capacity-building in biosafety to support effective implementation and enforcement of its biosafety regulatory framework. This includes continuous training programmes for biosafety enforcement officers to enhance technical competence, regulatory understanding, and operational readiness. The Department of Biosafety is committed to organising annual Institutional Biosafety Committee (IBC) seminars to strengthen institutional oversight and promote consistent application of biosafety standards. In addition, a series of biosafety training workshops and other thematic workshops have been conducted to address emerging issues, regulatory updates, and practical challenges in biosafety management. Capacity-building efforts are further reinforced through participation in specialised training programmes at the national and international levels, with officers being sent for training using both government-funded resources and sponsored training opportunities. These initiatives collectively demonstrate Malaysia’s sustained commitment to developing a skilled, knowledgeable and competent biosafety workforce.

Public participation is a mandatory requirement under the Biosafety Act 2007 for any application involving the release of LMOs. The National Biosafety Board is required to consider all public comments received during a designated consultation period before making a decision. In the case of Biosafety Act 2007 amendments, public participation is required as indicated through Regulatory Impact Analysis by Malaysia Productivity Corporation.

During the period of reporting, Malaysia has approved the import of LMO for direct use as food or feed, and processing (FFP) from non-Party. Malaysia has also approved export of LMOs for contained use activities both to Party as well as non-Party.

The Biosafety Act 2007 establishes clear prohibitions and significant penalties for any activities involving LMOs that are conducted without the required approval or notification. The penalties include substantial fines and potential imprisonment for individuals and corporate bodies. The nation's capacity to prevent illegal transboundary movements has been significantly strengthened through the formal partnership with the Malaysian Border Control and Protection Agency (AKPS), which enhances surveillance and enforcement at all points of entry. During the reporting period, no cases of illegal transboundary movements of LMOs have been detected.

The Biosafety Act 2007 provides the legal basis for including socio-economic considerations in the decision-making process, and the LBK has utilized this provision in some cases. A major advancement during this reporting period has been the systematic effort to develop a formal framework for this purpose. A key component of the GEF-6 project (ID: 9111) is dedicated to establishing "Parameters and methodologies for socio economic assessments" (Outcome 2B.1). This initiative is transforming the approach from an ad-hoc consideration to a structured, methodological process. The development of this framework will ensure that socio-economic impacts are assessed in a consistent and transparent manner, strengthening the overall quality and social robustness of the decision-making process.

Malaysia actively cooperates on biosafety at national, regional, and international levels. Key initiatives include hosting study visits to share regulatory best practices and participating in regional technical forums. A significant achievement is the formal strategic partnership with the Malaysian Border Control and Protection Agency (AKPS), which strengthens enforcement and institutional knowledge exchange at entry points. Furthermore, the GEF-supported capacity-building project (ID: 9111) has facilitated international expert collaboration to enhance risk assessment frameworks. Malaysia also promotes public engagement through platforms like the 'Biosafety Symposium 2025,' fostering dialogue among diverse stakeholders

The Department of Biosafety is progressing with amendments to the Act that will establish new provisions addressing liability and redress, with the amendments expected to be introduced in the second quarter of 2026.

The Department of Biosafety is progressing with amendments to the Act that will establish new provisions addressing liability and redress, with the amendments expected to be introduced in the second quarter of 2026.