Discover key regulatory updates from the week of November 11th in medical devices, IVD, SaMD, pharmaceuticals, biotech, and combination products, as recognised by the Global Index powered by Hoodin. This edition highlights top regulatory news and analyses, featuring significant updates from Cybers security & Infrastructure Security Agency (USA) and MHRA (UK).
Global Reg Index by Hoodin
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Top Picks for November 11th - November 17th
CISA, FBI, NSA, and International Partners Release Joint Advisory on 2023 Top Routinely Exploited Vulnerabilities Cybers security & Infrastructure Security Agency (CISA) Published Nov 12
North America | PHARMACEUTICAL | BIOTECH | MEDICAL DEVICES | IVD
SUMMARY The joint Cybersecurity Advisory, released by CISA, FBI, NSA, and international partners, highlights the top Common Vulnerabilities and Exposures (CVEs) routinely exploited by cybercriminals. It provides detailed guidance on implementing secure-by-design principles to reduce vulnerabilities in software and hardware. The advisory encourages vendors, developers, and organizations to adopt proactive measures to protect sensitive data and mitigate cyber risks. IMPLICATIONS Elevated Scrutiny on Cybersecurity in Regulatory SubmissionsWith increasing global attention on cybersecurity vulnerabilities, regulatory bodies like the FDA and EMA may heighten expectations for demonstrating robust cybersecurity measures in premarket submissions and postmarket surveillance. RAQA must anticipate deeper scrutiny on cybersecurity risk assessments and mitigation strategies.
Impact on Vendor Management and Supply ChainsThe emphasis on secure-by-design principles requires RAQA to reassess vendor qualification and oversight processes. Collaboration with suppliers to ensure secure software and hardware development becomes critical, especially for connected devices.
Increased Compliance Complexity Across JurisdictionsContributions from international agencies signal a shift toward harmonized global cybersecurity frameworks. RAQA teams will need to navigate evolving standards across multiple regions, ensuring compliance while avoiding delays in global product rollouts.
Public Consultation on the International Council for Harmonisation ICH E6 (R3) Guideline for Good Clinical Practice Annex-2 MHRA (UK) | Published Nov 15
EUROPE | PHARMACEUTICAL | BIOTECH | COMBINATION PRODUCTS
SUMMARY
The MHRA announced that Annex 2 of the ICH E6(R3) Good Clinical Practice (GCP) guideline, focused on non-traditional interventional clinical trials, has reached Step 2b and is open for public consultation. This update aims to address the application of GCP to novel trial designs and technological advancements, promoting a proportionate, risk-based approach for clinical trials. The ICH E6(R3) revision introduces an overarching principles section, Annex 1 for traditional trials, Annex 2 for non-traditional trials, and supporting documents to replace the current E6(R2). MHRA is gathering UK stakeholder feedback to contribute to the global consultation process.
IMPLICATIONS
Adaptation to Evolving GCP Standards:RAQA teams must anticipate changes in regulatory requirements for clinical trial design and oversight, especially concerning non-traditional trials (e.g., decentralized trials, adaptive designs). Preparing for these updates ensures alignment with future inspection and compliance standards.
Focus on Risk-Based Approaches:The guideline’s emphasis on proportionate risk-based frameworks will require RAQA teams to refine trial monitoring and quality assurance strategies, balancing innovation with patient safety and data integrity.
Stakeholder Engagement in Regulatory Shaping:This consultation presents a rare opportunity for life science companies to influence global regulatory frameworks. RAQA teams should actively participate, leveraging insights to shape policies that support operational feasibility and innovation.
* Top picks may not be the biggest news, as those updates might have already reached you. Instead, the top picks highlight the most important developments for key players in the life sciences industry that you may have missed during the week.
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