The field of medicine holds great promise for Cell and Gene Therapy (CGT), which calls for a strong Regulatory framework. Initiatives by the US FDA and EMA to expedite Regulatory procedures include a rise in CGT applications and creative programs like the Bespoke Gene Therapy Consortium (BGTC) and INTERACT meetings. However, achieving worldwide Regulatory uniformity, maintaining strict clinical trial oversight, and striking a balance between innovation and safety pose significant challenges. Nonetheless, robust communication and the integration of real-world evidence (RWE) are highlighted in recommended best practices.

To navigate the changing landscape and ensure that CGT's transformational potential is fulfilled while preserving ethical and scientific standards, collaboration among stakeholders is essential.

How can stakeholders ensure successful collaboration and Regulatory adaptation to unlock the transformative potential of CGT while maintaining standards of patient safety and efficacy? Gain valuable insights from our thought leadership article published by Pharma Focus Asia.