As the year winds down, Global Reg Top Picks & Index by Hoodin is taking a brief holiday pause—but make no mistake, we’re not resting. Instead, we’re using this time to reflect, analyse, and prepare for what lies ahead in 2025.
Our team, together with Hoodin’s advanced AI capabilities, will be meticulously reviewing all regulatory updates from 2024. We’ll identify the most impactful changes, uncover emerging trends, and project how these developments might shape the regulatory landscape in the coming year. But we won’t stop there. We’re factoring in known geopolitical and global shifts—like Trump’s return to office and its potential impact on the FDA—to bring you a comprehensive view of what’s to come.
From a European perspective, we’re also keeping a close eye on how the EU regulatory ecosystem continues to evolve, particularly as harmonisation efforts advance and new guidance reshapes the rules for life sciences. How will the EU’s steady march toward sustainability and digital health regulations influence global markets? What lessons can global industries draw from these trends?
Our holiday project isn’t just about looking back—it’s about looking ahead. We aim to equip RAQA professionals like you with foresight into the challenges and opportunities that 2025 will bring. Stay tuned for a special edition early next year, where we’ll reveal our insights and predictions, ensuring you have the tools to stay ahead in an ever-changing world of compliance.
Get ready—2025 starts now!
Hoodin Global Index Recap: Standout Updates for Fall 2024
As 2024 draws to a close, the Hoodin Global Index recap highlights some of the most significant updates from the fall and winter months. These key developments have shaped the regulatory landscape, particularly in the areas of cybersecurity, accelerated approvals, and medical device compliance. From the EU’s Cyber Resilience Act setting new cybersecurity standards to the FDA’s updated guidance on the accelerated approval of critical therapies, these updates are pivotal in influencing global strategies and market dynamics.
Here are the standout updates from the fall of 2024:
Voting result - Cyber Resilience Act (CRA)
Europe | Medical Devices | IVD | Pharmaceuticals EUR-Lex • Published Oct 7 2024
The European Union Council officially adopted the Cyber Resilience Act, introducing EU-wide cybersecurity requirements for products with digital elements, including medical devices and consumer IoT products. The act mandates compliance with new cybersecurity standards across the product lifecycle, with products needing to meet design, development, and production requirements to obtain the CE mark.
Implications: This regulation sets new cybersecurity standards and will affect medical devices and IoT products sold in the EU. Companies must ensure their connected devices meet the new criteria for seamless market access.
Review of Drug Master Files in Advance of Certain Abbreviated New Drug Application Submissions Under Generic Drug User Fee Amendments; Guidance for Industry; Availability.
North America| FDA (US) | Published Oct 15 2024
The FDA has issued final guidance on reviewing Type II Drug Master Files (DMFs) under the Generic Drug User Fee Amendments (GDUFA) III. The guidance aims to streamline the review of DMFs six months before the submission of Abbreviated New Drug Applications (ANDAs) or Prior Approval Supplements (PASs), speeding up the availability of generic drugs.
Implications: This final guidance facilitates quicker market access for generic drugs, particularly benefiting API suppliers and contract manufacturers.
Implementing Regulation under the Health Technology Assessment (HTA) framework.
Europe | Medical Devices | IVD EMA (EU) | Published Oct 21 2024
The European Union has published a new regulation under the Health Technology Assessment (HTA) framework, which improves collaboration for joint clinical assessments of medicinal products and medical devices. The regulation applies to products in oncology and advanced therapy areas, with phased implementation beginning in 2025.
Implications: This regulation aims to streamline clinical assessments across EU member states, particularly for oncology and advanced therapy products. Companies must align their market strategies with the HTA timelines to ensure efficient approval processes.
Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class III Devices
North America | MEDICAL DEVICES | FDA | Published Nov 26 2024
The FDA introduced a transitional enforcement policy addressing disruptions in the sterilization of Class III medical devices using ethylene oxide (EtO). The policy allows manufacturers to request enforcement discretion when making changes to their sterilization facilities, ensuring continued availability of critical devices during transitions.
Implications: This policy provides regulatory flexibility to manufacturers facing EtO sterilization disruptions, preventing supply chain shortages of critical Class III devices.
Expedited Program for Serious Conditions—Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry
North America | Pharmaceuticals | Biotech | Combination Products
FDA | Published Dec 4 2024
The FDA released draft guidance outlining its Accelerated Approval program, aimed at speeding up the development and review process for drugs and biologics intended for serious or life-threatening conditions. The guidance includes eligibility criteria, approval standards, and procedures for approval and withdrawal.
Implications: This program facilitates faster market access for therapies targeting high-priority areas such as oncology and rare diseases. It offers life science companies a streamlined path to bring critical therapies to market faster.
SAHPRA’s Action on Substandard GLP-1 Products – South Africa
South Africa | Pharmaceutical | Biotech | Combination Products
SAHPRA (South Africa) | Published Nov 8 2024
The South African Health Products Regulatory Authority (SAHPRA) issued a statement addressing the rise of substandard and falsified GLP-1 products, commonly used for diabetes and weight management. SAHPRA is intensifying efforts to ensure the safety and quality of GLP-1 products available in the country.
Implications: SAHPRA’s efforts will drive stricter compliance and oversight of GLP-1 products, improving market integrity and patient safety. This could lead to a more robust regulatory environment in emerging markets like South Africa.
Innovative Licensing and Access Pathway
Europe | Pharmaceutical | Biotech | Combination Products
MHRA | Published Nov 20 2024
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced the closure of its current Innovative Licensing and Access Pathway (ILAP) as of November 20, 2024, with a new pathway set to reopen in March 2025. The refreshed pathway will better support the development of innovative medicines and expedite their market access.
Implications: Companies must adjust their timelines and application strategies to align with the new ILAP criteria. The updated pathway is designed to foster more efficient access to innovative treatments, particularly for breakthrough therapies.
These updates from fall 2024 will play a crucial role in setting the stage for the evolving regulatory environment in 2025, with a growing emphasis on cybersecurity, accelerated market access, and higher standards for medical devices and pharmaceuticals. As we move into the new year, we will dive deeper into these developments and explore their long-term impacts on the life sciences, healthcare, and pharmaceutical industries. Stay tuned for more insights as we continue to monitor these trends and help you navigate the changing regulatory landscape.
Merry Christmas & New Year from Hoodin
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