top of page
Regulatory & Compliance
Upholding Safety, Ethics, and Standards in Cell & Gene Therapy
Cell and gene therapy is a rapidly advancing field that requires stringent oversight to ensure patient safety, product quality, and ethical conduct.
This section highlights relevant national and international regulatory frameworks, compliance requirements, and best practices that guide responsible development and application of these therapies.
SSCTR is committed to promoting awareness and adherence to these standards among researchers, healthcare professionals, and stakeholders in Malaysia and the region.
Asia’s Evolving CGT Approvals and Access Landscape
Published in Cytotherapy (Review Article) Asia’s CGT sector continues to expand with fast-track pathways in Japan, Korea, China and Singapore while India and Thailand advance through flexible access models and domestic innovation. Approvals for CAR-T, stem cell and gene therapies are rising and pricing differences highlight how local manufacturing and regulatory maturity shape affordability and access. Regional collaboration and shared infrastructure are identified as key lev
FDA Introduces New Pathway to Accelerate Personalized Gene Editing
Published on Endpoints News The FDA has unveiled a new “plausible mechanism pathway” to speed access to personalized gene editing therapies, inspired by the Baby KJ case. The approach aims to support rare disease treatment by allowing alternative trial designs while maintaining regulatory oversight. 👉 Read the full article: FDA unveils new path to speed personalized therapies, inspired by Baby KJ Disclaimer Images used are for illustrative purposes only and do not depict act
Patient Death Halts Intellia’s Phase 3 CRISPR Trial
Published on Fierce Biotech A patient in Intellia’s phase 3 trial of the CRISPR therapy nex-z has died following severe liver toxicity, prompting the FDA to keep both studies on hold. The company is investigating the liver signal and developing risk mitigation steps while monitoring all previously treated patients. 👉 Read the full article: Patient dies after receiving Intellia's CRISPR therapy Disclaimer Images used are for illustrative purposes only and do not depict actual
FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine
Published on Holland & Knight The FDA has released new draft guidance outlining expedited pathways for regenerative medicine therapies....
FDA Issues New Guidance on Cell, Gene, and Regenerative Therapies
Published on RAPS The US FDA has released updated guidance documents covering cell and gene therapies and regenerative medicine. These...
FDA Approves First Oral SERD Therapy for Resistant Breast Cancer
Published on LinkedIn (via Spencer Knight) The FDA has approved Inliruqo™ (imlunestrant) from Eli Lilly, the first oral estrogen receptor...
Europe’s Regulatory Shake-Up Raises Concerns for Advanced Therapies
Published on Cytotherapy A new perspective warns that restructuring advanced therapy oversight within the European Medicines Agency could...
FDA Approves TREMFYA® for Ulcerative Colitis Induction
Published via FDA & EU regulatory updates The FDA has approved TREMFYA® as the first and only IL-23 inhibitor with both subcutaneous and...
EU Grants Conditional Authorization for Zemcelpro Stem Cell Therapy
Published on: ExCellThera / Cordex Biologics The European Commission has conditionally authorized Zemcelpro (UM171 Cell Therapy), the...
EU Approves TEVIMBRA for Perioperative Lung Cancer
Published on: LinkedIn (Spencer Knight) The European Commission has approved TEVIMBRA (tislelizumab) from BeOne Medicines, the first PD-1...
FDA Approves First RNA-Targeted Therapy for HAE
Published on: LinkedIn (Spencer Knight) The U.S. FDA has approved DAWNZERA (donidalorsen) from Ionis Pharmaceuticals, the first...
Two Landmark Approvals for MASH in One Week
Published on: LinkedIn (Spencer Knight) In just five days, two breakthrough approvals have reshaped treatment for metabolic...
EU Approves AUCATZYL CAR T Therapy for Adult B-ALL
Published on: Autolus Therapeutics The European Commission has granted marketing authorization for AUCATZYL (obecabtagene autoleucel) to...
FDA Approves First Therapy for Recurrent Respiratory Papillomatosis
Published on: Precigen Investors The U.S. FDA has granted full approval to PAPZIMEOS (zopapogene imadenovec-drba), the first therapy for...
Global Access to Cell Therapy Requires Regulatory Adaptation and Flexibility
Published on ISCT Telegraft Blog by Francheska Juliano At the ISCT 2024 Annual Meeting in Vancouver, global experts discussed how access...
bottom of page