TABLE 7.

Summary of key ministry, regulatory bodies, and their publications to safeguard modern biotechnology in term of regulations and guidelines, biosafety and biosecurity in Malaysia.

	Description	Objective(s) and focus
Regulations and guidelines
Key ministry	Ministry of Health (MOH)	• Facilitate and support the people to attain their potential fully in health, appreciate health as a valuable asset, take individual responsibility and positive action for their health. • Ensure a high-quality health system that is customer centered, equitable, affordable, efficient, technologically appropriate, environmentally adaptable, and innovative. • Emphasize professionalism, caring and teamwork value, respect for human dignity, and community participation.
Regulatory bodies	Medical Development Division	Develop medical services in the MOH’s hospital, in particular, the speciality and sub-speciality services.
	Medical Practice Division	Ensure safe, efficient and quality health care standards through monitoring, legislation, regulation and regulation.
	Medical Device Authority	Provide regulatory control of the medical device industry in Malaysia, through compliance of act by ensuring safety and performance to protect public towards excellent customer satisfaction.
	National Pharmaceutical Regulatory Agency (NPRA)	Safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.
Publications	Sale of Drugs Act 1952: Control of Drugs and Cosmetic Regulations (1984)	All drugs in pharmaceutical dosage forms and cosmetics must be registered before sales and marketing are permitted in the country.
	Guidelines for Stem Cell Research and Therapy (2009)	Facilitate researchers and clinicians from MOH, universities and private sector that are involved in stem cell research and therapy (adult stem cells and human embryonic stem cells)
	National Standards for Stem Cell Transplantation (2009)	• Laboratory framework to support stem cell therapy from the point of collection, processing, storage, handling and infusion of the products to ensure patients’ safety. • Standards apply to sources of cells currently used for transplantation and cell therapy (bone marrow, peripheral blood and umbilical/placental blood).
	National Guidelines for Hemopoietic Stem Cell Therapy (2009)	Standards for any clinical facility in Malaysia performing hemopoietic stem cell transplants.
	National Standards for Cord Blood Banking and Transplantation (2009)	Standards on cord blood banking for transplantation in both private and public cord blood banks in Malaysia
	Checklist for Research on Stem Cell and Cell-based Therapies (2009)	Describes some of the procedures to be followed in making applications for stem cell and cell-based research involving human subjects, prepared by National Stem Cell Research and Ethics Sub-committee (NSCERT).
	Guidance Document and Guidelines for Registration of Cell and Gene Therapy Products (CGTPs) in Malaysia (2016)	• Outline the concept and basic principles of CGTPs. • Introduce the registration framework and guidelines to be applied. • Provide applicants with a “user guide” for the relevant scientific data and information, to substantiate the claimed quality, safety and efficacy of the product.
Biosafety and biosecurity
Key ministry	Ministry of Energy and Natural Resources	Provide exceptional services in the management of natural resources and conservation of the environment in line with the national vision.
	Ministry of Health (MOH)	same as above
	Ministry of Defence (MINDEF)	Protect and defend the national interest which is the cornerstone of the sovereignty, territorial integrity and economic prosperity of the nation
Regulatory bodies	National Biosafety Board (NBB)	The regulatory body for making a decision pertaining to the release, importation, exportation and contained use of any living modified organism (LMOs) derived from modern biotechnology.
	Department of Biosafety (DOB)	• Evaluate the applications for the release, importation, exportation and contained use of living modified organism, and the release of products of such organisms. • Carry out the monitoring and enforcement activities under the Biosafety Act 2007 • Provide technical advisory on the handling of living modified organisms. • Raise public awareness regarding the role of biosafety in human, plant and animal health, the environment and biological diversity. • Promote research, development, educational and training activities relating to biosafety.
	Genetic Modification Advisory Committee (GMAC)	• Makes decisions on LMOs use in Malaysia and to provide scientific, technical and other relevant advice to the NBB. • Identification and safety management of risks associated with the use of genetically modified organisms (GMOs) and products containing or consisting of GMOs.
	Institutional Biosafety Committee (IBC)	Monitor any work which involves the use of any LMOs, or recombinant DNA (rDNA) molecule materials conducted at or sponsored by the organization, irrespective of the source of funding.
Publications	Biosafety Act (2007)	Regulate the release, importation, exportation and contained use of LMOs, and the release of products of such organisms, with the objectives of protecting human, plant and animal health, the environment and biological diversity.
	Biosafety (Approval and Notification) Regulation (2010)	• Ensuring the environmental and human safety of LMOs and giving the public confidence in LMO products by established the IBC. • The activities covered include the approval, certification and notification of any release and importation of LMOs and LMO products.
	Biosafety Guidelines for Contained Use Activity of Living Modified Organism (2010)	• Identify the Biosafety Levels (BSL) for containment of any LMO activity. • Describe work practices under the various containment levels. • Outline the minimum requirements for setting up facilities for contained use activities of LMO. • Identify equipment requirements under the different containment levels.
	Guidelines for Institutional Biosafety Committees (2010)	Describes the setting up of the IBCs, its role and functions and also processes that must be followed when obtaining, using, storing, transferring, or destroying LMO/rDNA materials.
	Malaysia Laboratory Biosafety and Biosecurity Policy and Guideline (2015)	• Basic concepts and approaches in the form of policy and guidelines that govern all activities involving the handling, manipulation working, using, storing and disposing of infectious and potentially infectious agents/materials and microbial toxins in all forms and sizes of laboratories in Malaysia. • Reference for the development and establishment of the respective institutional code of practice for good microbiological technique (GMT), biosafety and biosecurity in a laboratory and defined containment zone.
	Draft Code of Conduct for Biosecurity in the Framework of Biological Weapons	• Raise awareness of potential dual-use and the need to prevent malicious misuse. • Help research institutions to avoid any direct or indirect contributions to the development and production of potential biological weapons. • Demonstrate that research institutions in the country are fully compliant with national and international legislation and support the Biological and Toxin Weapons Convention Nucleus (BTWC) as an international norm prohibiting biological weapons.