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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.

Infographic of the FDA building with DNA strands and documents symbolizing regenerative medicine regulatory guidance.

FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine

Published on Holland & Knight The FDA has released new draft guidance outlining expedited pathways for regenerative medicine therapies....

Regulatory & Compliance

Infographic-style illustration of an FDA building surrounded by abstract cell and gene icons.

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...

Regulatory & Compliance

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...

Regulatory & Compliance

Infographic showing justice scales balancing DNA and regulatory papers, symbolizing European CGT policy changes.

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...

Regulatory & Compliance

A clinical-style image of a syringe and colon illustration symbolizing treatment advancement for ulcerative colitis.

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...

Regulatory & Compliance

A patient holding hands with a loved one in a hospital room, symbolizing new hope from authorized stem cell therapy.

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...

Regulatory & Compliance

Abstract illustration of glowing shield over lungs, symbolizing EU approval of immunotherapy for lung cancer.

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...

Regulatory & Compliance

A glowing RNA strand shielding a human silhouette, symbolizing RNA-targeted therapy for hereditary angioedema.

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...

Regulatory & Compliance

A doctor discussing liver health scans with a patient, symbolizing new approvals for MASH treatment.

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...

Regulatory & Compliance

Illustration of immune cells targeting papilloma growths in the respiratory tract, representing new FDA-approved therapy for RRP.

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...

Regulatory & Compliance

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...

Regulatory & Compliance

Diverse patients waiting at a regulatory checkpoint as professionals build a bridge for CGT access.

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...

Regulatory & Compliance

Biotech lab hallway narrowing into a regulatory bottleneck labeled "CMC" with queued gene therapy vials behind it.

CMC Hurdles Are Now the Biggest Barrier to CGT Approval

Published on Drug Discovery News Recent FDA rejections of three advanced therapies, Capricor’s CAP‑1002, Ultragenyx’s DTX401, and Rocket...

Regulatory & Compliance

FDA Eases REMS and Monitoring Rules to Improve CAR-T Access

Published on LinkedIn via Spencer Knight The FDA has updated CAR-T therapy regulations for BMS’ Abecma and Breyanzi, removing REMS...

CGT Milestones

Illustration of patient and legal symbols highlighting debate over FDA authority in regulating stem cell treatments.

Goldwater Asks Supreme Court to Limit FDA’s Authority Over Stem Cell Treatments

Published on Goldwater Institute The Goldwater Institute has submitted a Supreme Court brief challenging the FDA’s authority to regulate...

Regulatory & Compliance

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Regulatory & Compliance

Upholding Safety, Ethics, and Standards in Cell & Gene Therapy

FDA Issues Draft Guidance on Expedited Programs for Regenerative Medicine

FDA Issues New Guidance on Cell, Gene, and Regenerative Therapies

FDA Approves First Oral SERD Therapy for Resistant Breast Cancer

Europe’s Regulatory Shake-Up Raises Concerns for Advanced Therapies

FDA Approves TREMFYA® for Ulcerative Colitis Induction

EU Grants Conditional Authorization for Zemcelpro Stem Cell Therapy

EU Approves TEVIMBRA for Perioperative Lung Cancer

FDA Approves First RNA-Targeted Therapy for HAE

Two Landmark Approvals for MASH in One Week

EU Approves AUCATZYL CAR T Therapy for Adult B-ALL

FDA Approves First Therapy for Recurrent Respiratory Papillomatosis

Global Access to Cell Therapy Requires Regulatory Adaptation and Flexibility

CMC Hurdles Are Now the Biggest Barrier to CGT Approval

FDA Eases REMS and Monitoring Rules to Improve CAR-T Access

Goldwater Asks Supreme Court to Limit FDA’s Authority Over Stem Cell Treatments

Sarawak Society for Cell & Gene Therapy Research

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