Malaysia has strict regulations for cell and gene therapy.
In Malaysia, the performance of regenerative therapies such as "stem cell therapy" or "gene therapy" mandates strict compliance with government regulations.
The products used in this therapy are strictly regulated by the National Pharmaceutical Regulatory Agency (NPRA) under the Ministry of Health Malaysia (MOH). Furthermore, Malaysian law (Control of Drugs and Cosmetics Regulations 1984) explicitly states that manufacturing, selling, or supplying unregistered products is illegal.
In other words, the unauthorized provision of cell therapy may constitute a legal offense. To ensure safe treatment, it is essential to verify that both the facility and products possess the requisite authorizations.
NPRA Official Guide
Directory of NPRA Certified Stem Cell Facilities
The NPRA publishes a list of GMP-compliant cell and gene therapy product manufacturing facilities to clearly indicate which domestic facilities meet the aforementioned standards. As of the latest list dated July 29, 2024, there are only 8 NPRA-certified cell and gene therapy product manufacturing facilities in Malaysia.
NPRA-Certified Cell and Gene Therapy Products Manufacturing Facility
The facilities listed herein have been verified through on-site inspection by NPRA for compliance with GMP standards, which signifies that the manufacturing environment and procedures for cell therapy products are managed in accordance with international standards.
In other words, if a facility not listed in this official registry produces or clinically administers stem cells, it is highly probable that it has not obtained NPRA certification.
Patients and healthcare professionals are advised to verify whether facilities providing cell and gene therapy products are covered by this certification list as an important step in ensuring safety.
Risk of Using Facilities Without Authorization
Cell and gene therapy products manufactured in unlicensed facilities pose the following serious risks.
Safety Risk
Cell and gene therapy products manufactured and administered in environments lacking proper GMP/GTP management are highly likely to lack adequate sterility controls and quality control measures, thereby increasing the risk of bacterial and viral infections, as well as unexpected immune reactions.
Internationally, cases have been documented where patients receiving unauthorized stem cell therapy suffered serious infections, tumor formation, and even death, demonstrating that a lack of quality control can pose life-threatening dangers.
Uncertainty of Effectiveness and Quality
For therapies lacking scientific verification, effectiveness and safety are not guaranteed. Despite significant expense, desired outcomes may not be achieved, and in some cases, the patient's condition may deteriorate.
However, it has come to light that several private clinics are offering unauthorised therapies, marketed for conditions such as joint diseases, diabetes, anti-aging, and various other ailments. Patients are advised to exercise caution to avoid being misled by such exaggerated claims.
Legal and Ethical Issues
As previously mentioned, unlicensed facilities are highly likely to constitute a violation of the law. Furthermore, should health issues or damages arise at such facilities, obtaining public assistance may be difficult.
Therapy administered without authorization from a supervisory authority may lack adequate informed consent systems or protocols for responding to adverse effects, which can lead to ambiguity regarding liability if a patient suffers harm.
Furthermore, the allocation of time and resources to such facilities also signifies a forfeiture of the opportunity to receive regular, evidence-based care, thereby necessitating a meticulous evaluation in healthcare selection.
We are committed to ensuring our patients can use advanced medical care with confidence and trust, by adhering to the guidelines of Malaysian authorities and continuously improving our technology and systems every day.
Going forward, we will continue to prioritize compliance with the law and quality assurance, and contribute to the development of safely accessible regenerative therapies.