During the week of October 21st, the Global Index powered by Hoodin recognised 111 regulatory news and updates related to medical devices, IVD, SaMD, pharmaceuticals and biotech (and combination products). Check out what the Hoodin system recognised as the top picks* below, where they are presented as summarised versions together with an analysis of the potential implications. From last week there are important updates and news by EMA (EU), JAZMP (Slovenia) and FDA (US) in this issue of Global Reg Top Picks by Hoodin.
Cut through the noise of regulatory updates and stay ahead with the some of the most impactful news from around the globe—handpicked and analysed just for you.
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Top Picks for October 21 - October 27
Implementing Regulation under the Health Technology Assessment (HTA) framework. EMA (EU) | Published Oct 15
EUROPE | MEDICAL DEVICES | IVD
SUMMARY The European Union's Official Journal has published the second Implementing Regulation under the HTA Regulation (EU 2021/2282), establishing procedural rules for cooperation between the Member State Coordination Group on HTA, the European Commission, and the EMA. This regulation aims to facilitate the joint clinical assessment of medicinal products and medical devices, ensuring secure information exchange while protecting commercially confidential data. The new regulations will come into effect on 12 January 2025, starting with oncology medicines and advanced therapy medicinal products, followed by orphan medicines in January 2028, and expanding to all new medicines by January 2030.
IMPLICATIONS Strategic Planning: Stakeholders, particularly pharmaceutical and medical device companies, must prepare for the HTA regulations' implementation by aligning their development and market entry strategies with the upcoming assessment timelines.
Enhanced Collaboration: The regulation promotes greater cooperation among Member States, offering businesses a structured pathway for engaging with regulatory bodies, which could improve the efficiency and predictability of the approval process.
Focused Innovation: By initially targeting oncology and advanced therapy products, companies operating in these areas can prioritise compliance and readiness, ensuring that their innovations align with EU-level assessments.
Confidentiality Assurance: The emphasis on protecting commercially sensitive information provides a framework for companies to share critical data with regulators while safeguarding proprietary information.
Long-Term Market Access: Understanding the phased approach of the HTA implementation allows companies to anticipate future requirements and adapt their products to meet evolving regulatory expectations, ultimately facilitating smoother market access.
Electronic Delivery of Documents in Procedures | JAZMP (Slovenia) | Published Oct 25 EUROPE | PHARMACEUTICALS | BIOTECH | MEDICAL DEVICES | IVD
SUMMARY
The announcement regarding the electronic delivery of documents through the SI-CeV system by the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (JAZMP) pertains primarily to the regulatory framework for pharmaceuticals and medical devices. The JAZMP oversees the approval and monitoring of medicinal products, which includes both human and veterinary medicines, as well as medical devices and in vitro diagnostics (IVDs).
This move to electronic delivery is part of a broader digital transformation within the agency, aimed at improving efficiency and security in communications related to the submission and management of applications and documentation for these products.
IMPLICATIONS
Efficiency and Speed: The electronic system will streamline communications between the JAZMP and Marketing Authorisation Holders (MAHs), resulting in quicker responses and reduced administrative burdens.
Improved Security: Utilising secure electronic mailboxes enhances the confidentiality and security of sensitive documents, thereby reducing risks associated with data breaches.
Future-Proofing Compliance: By transitioning to electronic document delivery, JAZMP aligns with international best practices, making it easier for stakeholders to comply with evolving regulatory frameworks.
Enhanced Communication: Stakeholders can expect clearer communication from the JAZMP, as they will receive timely updates and information regarding their submissions.
Extension of Comment Period - Chemical Analysis for Biocompatibility Assessment of Medical Devices; Draft Guidance for Industry and Food and Drug Administration Staff FDA (US) | Published Oct 22
NORTH AMERICA | PHARMACEUTICALS | BIOTECH | IVD
SUMMARY
The FDA has extended the public comment period for its draft guidance, titled "Chemical Analysis for Biocompatibility Assessment of Medical Devices," initially opened on 20 September 2024. This guidance offers recommendations to help manufacturers perform chemical analyses that assess the safety of materials used in medical devices. Public comments on this draft are now accepted through 19 December 2024, offering additional time for stakeholders to review and contribute insights. Submissions can be made electronically or by mail, with guidelines to safeguard any confidential information included in comments.
IMPLICATIONS Refine Compliance Strategy: Provides additional time to analyse and ensure alignment with FDA's expectations on chemical analysis methods, helping streamline your product's regulatory pathway.
Shape Industry Standards: Opportunity to voice specific needs or concerns, potentially influencing the final recommendations to be more practical and realistic for device manufacturing and testing.
Enhance Product Acceptance: With FDA's focus on biocompatibility, feedback now can help craft guidance that supports better device safety data, reducing approval delays or additional testing costs down the line.
Strengthen Safety Credibility: Aligning with or contributing to the FDA’s standards can elevate trust among consumers and healthcare providers, as the guidance is aimed at ensuring safer materials in medical devices.
* 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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