Strict Regulations on Cell and Gene Therapy in Malaysia
In Malaysia, the provision of regenerative medicine such as “stem cell therapy” and “gene therapy” must comply with strict government regulations.
Products used in these treatments are strictly regulated by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health (MOH) Malaysia. Furthermore, under Malaysian law (Control of Drugs and Cosmetics Regulations 1984), it is clearly stated that manufacturing, selling, or administering unregistered products is illegal.
In other words, offering unlicensed cell therapies may constitute a violation of the law. To ensure safe treatment, it is essential to confirm whether the facility and products are officially licensed.
List of NPRA-Licensed Stem Cell Facilities
To clarify which facilities meet these standards, the NPRA publishes a list of cell and gene therapy product manufacturing facilities that comply with Good Manufacturing Practice (GMP). According to the latest list as of July 29, 2024, there are only eight facilities in Malaysia licensed by the NPRA to manufacture cell and gene therapy products.
NPRA-Licensed Cell and Gene Therapy Product Manufacturing Facilities
Facilities listed here have been inspected by the NPRA and confirmed to comply with GMP standards. This means their manufacturing environments and procedures for cell therapy products are managed to international quality standards.
Conversely, if a facility manufacturing or providing clinical cell therapy is not on this official list, there is a very high likelihood that it is operating without NPRA approval.
Patients and healthcare professionals are strongly encouraged to check whether a facility offering cell or gene therapy products appears on this official licensing list as a key measure of safety.
Risks of Using Unlicensed Facilities
Cell and gene therapy products manufactured at unlicensed facilities carry significant risks, including:
Safety Risks:
Products made or provided in environments without proper GMP/GTP management may lack adequate sterility control or quality testing. This greatly increases the risk of bacterial or viral infections, unexpected immune reactions, and other serious health hazards.
In fact, overseas cases have been reported where patients receiving unapproved stem cell therapies developed severe infections, tumor formation, or even died—highlighting how the absence of quality control can be life-threatening.
Uncertain Efficacy and Quality:
Treatments that have not undergone scientific validation cannot guarantee efficacy or safety. Patients may spend large sums without achieving the expected results, and in some cases, their condition may worsen.
It has been pointed out that some private clinics advertise unapproved treatments for conditions such as joint disorders, diabetes, or anti-aging, and patients must remain cautious not to be misled by exaggerated claims.
Legal and Ethical Concerns:
As mentioned, unlicensed facilities are likely in violation of the law, and in the event of disputes or health damage, public recourse may be difficult to obtain.
Treatments provided without regulatory approval may also lack proper informed consent processes and adequate systems to address adverse events, leaving patients at risk without clear accountability.
Spending time and money on such facilities can also mean missing the opportunity to receive legitimate, evidence-based treatments, making careful judgment essential when choosing a medical provider.
We are committed to ensuring that patients can receive advanced medical care with confidence and trust. We strictly adhere to Malaysian regulatory guidelines and continuously strive to improve our technology and systems.
We will continue to prioritize compliance and quality, contributing to the advancement of safe and reliable regenerative medicine.