Regulatory Affairs Editorial

  1. TMF Reference Model Affiliation With CDISC Could Improve TMF Interoperability 3/20/2023

    There is a growing desire within the clinical trials industry for better data integration — not just to help regulators, but also to help sponsors manage trials more effectively. The recent affiliation of the TMF Reference Model with the Clinical Data Interchange Standards Consortium (CDISC) may become key to making this possible.

  2. ICH Guideline Q9(R1) On QRM, Part 1: Formality & Risk-based Decisions 2/28/2023

    The long-awaited revision to ICH’s harmonized tripartite guidance on Quality Risk Management (QRM), Q9(R1), was adopted on Jan. 18, 2023. While the primary principles of QRM in this new version remain consistent with the original 2005 document, the revised guidance has four new subsections. This article examines the topics of formality and risk-based decisions.

  3. New EU Directive Marks Cybersecurity Regulatory Paradigm Shift For Bio/Pharma & Medical Devices 2/15/2023

    The EU's new Directive 2022/2555 on the Security of Network and Information Systems (“NIS2”) mandates cybersecurity risk management measures and reporting requirements for all segments of our industry, including labs; CROs and CDMOs; and manufacturers of APIs, bio/pharmaceuticals, and medical devices.

  4. The Holistic Guide To Supply Chain For Cell & Gene Therapy Startups 1/19/2023

    How does the cell and gene therapy supply chain team stay ahead of the expected changes and respond at the speed the developing program expects? Supplier selection, raw materials, built-in quality, warehousing and logistics, and traceability are all covered in this article.

  5. How To Educate Regulators On What Matters To Patients 12/13/2022

    With the greater emphasis on patient-centricity, patients are valued as an active participant in their own care. There is an increased emphasis on evaluating treatment benefit using patient-centric concepts and input from the patient community. Regulators now urge sponsors and researchers to systematically engage patients and caregivers to define the disease burden and unmet needs.

  6. 3 Tips To Navigate The Increasingly Complex PVA Landscape 12/8/2022

    The shifting landscape of industry innovation and unconventional partnerships has created a need for an increased number of pharmacovigilance agreements (PVAs) with higher levels of complexity. As a result, many stakeholders face new challenges in drafting, negotiating, and finalizing PVAs.

  7. Survey Reveals High Levels Of CTIS Adoption In Europe 11/8/2022

    Early feedback from users of the EMA’s new centralized clinical trials information system (CTIS) is broadly positive, according to a survey of 400 U.S. and European life science leaders. CTIS use isn’t mandatory until after the end of January 2023, but industry uptake has already been strong.

  8. India’s New Drugs, Medical Devices, And Cosmetics Draft Bill 2022 11/7/2022

    To accommodate changing requirements and encourage the adoption of new technology, India’s Ministry of Health and Family Welfare released a draft bill in July 2022 to replace the existing Drugs and Cosmetics Act 1940. What are the major areas of change and how much of an impact will there be?

  9. FDA Releases Final Guidance On RWD/RWE Submissions For Drugs & Biologics 10/20/2022

    The guidance describes the approach sponsors should use to identify if and how real-world data (RWD) and real-world evidence (RWE) are incorporated into their regulatory submissions. The FDA notes that this guidance specifically applies to INDs, NDAs, and BLAs that contain RWD and RWE.

  10. Search For Similarity: Regulatory Considerations Of Drug Abuse Potential Investigations 10/14/2022

    This article focuses on FDA and EMA regulatory guidelines surrounding drug abuse/dependence and abuse potential investigations, particularly in animal studies. Discussion includes penetration of the blood-brain barrier, structural similarity screening, and investigation of pharmacological similarity.