Azmi & Associates - The Regulatory Framework of Stem Cell Research and Therapy in Malaysia

Stem cells are undifferentiated cells with the capacity to evolve into diverse cell types and tissues. Within the human body, they function as an internal repair mechanism during both early development and throughout life. Stem cells possess distinctive differentiation capabilities, offering much potential for medical treatments through stem-cell-based therapies. These therapies can restore damaged or lost cells, potentially transforming medical treatments and regenerative medicine.

However, the ethical complexities surrounding the boundary-crossing nature of stem cell usage present regulatory challenges distinct from those of traditional medicine. One illustration of this is the emergence of private laboratories due to the increasing industry interest in stem cell transplantation. These facilities offer services for the collection, processing, and utilisation of human adult stem cells for therapy, sourced from various biological materials, and operate under existing regulations and guidelines, overseen by registered medical practitioners.

Recognising the need for a proper mechanism to oversee the field, Malaysia has started formulating regulations to govern stem cell research and therapy based on sound scientific principles and international best practices, modelled after benchmarked regulatory authorities to balance scientific advancement with ethical principles and public safety.

Click here to read the full legal alert.

Contact the authors for more information - Ling Shin Ying and Nurfarahin Zainal Abidin.