Regulatory Insights

  1. Rising Sun: The Drug Pricing Environment In Japan Is On The Up 3/18/2025

    Japan’s recent pharmaceutical pricing reforms present new opportunities for the industry, fostering innovation while aiming to ensure faster access to treatments.

  2. Early Network Mapping To Guide HTA Literature Reviews 3/18/2025

    How do we identify the right evidence efficiently? Early network mapping can help manufacturers balance a focused scope with the need to conduct indirect treatment comparisons.

  3. How Will Medical Devices Be Affected In The Era Of EU HTA? 3/18/2025

    The EU Health Technology Assessment Regulation (HTAR) mandates Joint Clinical Assessments (JCAs) for high-risk medical devices and medicines, guiding manufacturers in clinical study requirements and regulatory compliance.

  4. Understanding The UK's International Recognition Procedure 3/18/2025

    The UK's International Recognition Procedure (IRP) streamlines market access for medicines. Learn how its targeted assessments foster quicker approvals and innovation.

  5. What The Inspectors Want: A Guide To TMF Inspection-Readiness 3/18/2025

    Regulatory authorities expect sponsors to maintain proper TMF oversight. This article outlines strategies for inspection readiness, risk-based reviews, access control, and best practices for successful compliance.

  6. Navigating The Evolving Landscape Of Immunotherapy in Oncology 3/17/2025

    Immunotherapy is revolutionizing oncology, enhancing patient outcomes through targeted treatments. This evolving landscape includes checkpoint inhibitors, and personalized medicine, shaping the future of cancer care.

  7. Pioneering Gene Therapy In Rare Diseases 3/17/2025

    Overcoming barriers to gene therapy development requires continued innovation in manufacturing processes, harmonized regulatory approaches, and outcome-based pricing models.

  8. Evolution Of Clinical Trials In Europe 3/17/2025

    The CTR and CTIS represent a paradigm shift in European clinical research, fostering a more efficient and transparent trial environment.

  9. The Future Of Good Clinical Practice: The ICH E6(R3) Update 3/17/2025

    The release of the ICH E6(R3) Good Clinical Practice guideline in January 2025 marks a shift in clinical research, with significant implications for CROs, trial design, and quality management. 

  10. Three Key Takeaways From The PDA Annex 1 Workshop 3/17/2025

    Annex 1's impact on sterile manufacturing was dissected at PDA's Dublin workshop. Regulators stressed risk management, centralized control strategies, and the value of personnel knowledge.