Real-World Data (RWD)

Netherlands Minister Declines Cohort Study on Health Effects of Occupational Pesticide Exposure

The Dutch government declined to launch a national pesticide exposure study in March 2026, opting to rely on international data and upcoming domestic advice. This signals a strategic reliance on global evidence for occupational disease recognition, potentially accelerating the inclusion of pesticide-related conditions in national liability and compensation frameworks.

2 Apr 2026, 10:18open.overheid.nlNetherlands

South Korea MFDS Consults On Draft Partial Amendment to Medical Device Approval, Notification and Examination Regulation (Notice No. 2026-167)

South Korea's MFDS proposed amendments to medical device regulations on March 30, 2026, to streamline approval processes and transition periods. The changes facilitate market access by expanding the use of real-world evidence and reducing administrative burdens for foreign-language documentation and product modifications.

1 Apr 2026, 18:39mfds.go.krSouth Korea

US FDA Publishes FY 2024 GDUFA Science and Research Report

The US FDA has released its FY 2024 GDUFA report, detailing scientific advancements that will shape future regulatory standards for generic drugs and complex formulations. Firms should integrate these updated methodologies—particularly regarding nitrosamine impurities and AI-driven bioequivalence—into their R&D and compliance pipelines to mitigate approval risks.

28 Mar 2026, 18:45fda.govUnited States

US Department of Veterans Affairs Issues Biennial Report on Toxicant Exposure at Karshi-Khanabad Air Base (K2)

The US VA's 2025 biennial report on K2 air base toxicant exposure finds no elevated health risks to date, despite detecting depleted uranium at background levels. These findings provide the scientific baseline for upcoming VA rulemaking that may expand 'presumptive condition' status for veterans exposed to toxic substances.

28 Mar 2026, 09:34govinfo.govUnited States

New Mexico DOH Proposes Repeal and Replacement of 7.4.3 NMAC on Disease and Public Health Reporting

New Mexico is proposing to repeal and replace its public health reporting regulations, introducing expanded mandates for disease surveillance and electronic data submission by April 2026. Healthcare providers and laboratories should prepare for increased reporting burdens and infrastructure updates to comply with new sentinel surveillance and emergency department data requirements.

27 Mar 2026, 06:59nmhealth.orgUnited States

Germany (BAuA) Highlights Expert Consensus on Ocular Light and Optical Radiation Exposure as a Health Determinant

Germany’s BAuA has endorsed an expert consensus framing 24-hour ocular light exposure as a critical health determinant, signaling a shift toward standardized measurement and research. While no immediate regulatory changes are introduced, this focus on metrology and dose-response data suggests future tightening of occupational exposure limits for optical radiation.

18 Mar 2026, 19:24baua.deGermany

US FDA Launches Adverse Event Monitoring System (AEMS) Look-Up Tool

The US FDA has launched the Adverse Event Monitoring System (AEMS), a unified real-time platform consolidating adverse event reporting for all regulated products by May 2026. This shift to real-time public transparency increases reputational and litigation risks, requiring companies to proactively monitor safety signals and consumer complaints to manage market perception.

16 Mar 2026, 16:19fda.govUnited States

US CMS Finalises OASIS-E2 Guidance And Discontinues Legacy iQIES Interface From 1 April 2026

CMS has finalized the OASIS-E2 Guidance Manual and will retire the legacy iQIES manual-entry interface effective April 1, 2026. Home health agencies must transition to automated data file uploads and update assessment workflows to maintain compliance with mandatory quality reporting standards.

10 Mar 2026, 11:28cms.govUnited States

EU Publishes Four-Column Negotiation Table for the New Union Code on Medicinal Products

The Council has published the four-column negotiation table for the new EU Pharmaceutical Directive, advancing the comprehensive modernization of the Union's medicinal product framework. This overhaul will redefine market exclusivity, environmental compliance, and authorization pathways, necessitating a strategic review of product portfolios and regulatory pipelines.

8 Mar 2026, 14:17data.consilium.europa.euEuropean Union

US FDA Announces Availability of Final ICH M14 Real-World Data Guidance for Non-Interventional Safety Studies

The US FDA has finalized the ICH M14 guidance, establishing harmonized global standards for using real-world data (RWD) in non-interventional safety studies for medicines. This alignment reduces regulatory friction for post-marketing safety assessments and signals a clear shift toward standardized, data-driven evidence for drug and vaccine monitoring.

5 Mar 2026, 06:55federalregister.govUnited States

US FDA Announces Availability of Final ICH E2D(R1) Guidance on Postapproval Safety Data and Individual Case Safety Reports

The US FDA has finalized the ICH E2D(R1) guidance, modernizing standards for postapproval safety reporting to include data from social media and patient support programs. Companies must update pharmacovigilance workflows to integrate diverse real-world data sources, ensuring compliance with harmonized international safety reporting expectations.

5 Mar 2026, 06:55public-inspection.federalregister.govUnited States

US CDC Proposes Extension of National Firefighter Registry for Cancer Information Collection

The US CDC has proposed extending the National Firefighter Registry for Cancer data collection to continue monitoring occupational health risks through 2028. This ongoing data collection will likely drive future occupational safety standards and risk-reduction policies regarding hazardous exposures in firefighting.

27 Feb 2026, 14:54federalregister.govUnited States

Germany: BfR Launches German Poisoning Registry (DVR)

Germany has launched the German Poisoning Registry (DVR), centralizing nationwide poisoning incident data to enhance risk assessment and trend detection. Manufacturers should anticipate more granular market surveillance and faster regulatory responses to product-related safety incidents as authorities gain real-time visibility into exposure patterns.

22 Feb 2026, 15:53bfr.bund.deGermany

US FDA Seeks Comment on Emerging Drug Safety Technology Program Information Collection

The US FDA is soliciting feedback through March 20, 2026, on its Emerging Drug Safety Technology Program to formalize industry dialogue on AI-driven safety monitoring. This initiative signals a shift toward structured regulatory oversight of emerging technologies, offering firms a strategic opportunity to influence future compliance standards for post-market surveillance.

18 Feb 2026, 20:49federalregister.govUnited States

GB OPSS Publishes Research On Feasibility Of Collecting NHS Accident Data For Consumer Product Injuries

The UK OPSS has concluded that current NHS accident data is insufficient for systematic product safety surveillance, signaling a push for more targeted injury data collection. Manufacturers should anticipate more rigorous market surveillance and potential future data-sharing requirements as regulators seek to bridge evidence gaps in product-related risks.

18 Feb 2026, 20:44gov.ukUnited Kingdom

China NMPA Orders Revision of Package Inserts for Racemic Anisodamine Hydrochloride Injection Products

China’s NMPA has mandated safety-driven revisions to package inserts for Racemic Anisodamine Hydrochloride injections, requiring regulatory filings by May 2, 2026. MAHs must rapidly update risk communications and labels to reflect new adverse reaction data, necessitating supply chain adjustments and intensified post-market surveillance.

13 Feb 2026, 11:46nmpa.gov.cnChina

EMA Publishes Veterinary Union Pharmacovigilance Database Best Practice Guide

The EMA has updated its veterinary pharmacovigilance framework with new best practice guidance for signal management and adverse event reporting. Marketing authorization holders must ensure internal systems and data workflows align with these technical standards to maintain compliance and effective post-market safety monitoring.

29 Jan 2026, 20:18bvl.bund.deGermanyEuropean Union

EU SCHEER Updates Weight Of Evidence Approach For Risk Assessment (2026)

EU SCHEER has updated its Weight of Evidence (WoE) framework for risk assessment, formalizing the integration of New Approach Methodologies (NAMs) and real-world data. This standardized methodology will increase the rigor and transparency of scientific opinions, directly influencing future regulatory restrictions and safety standards for chemicals and consumer products.

9 Jan 2026, 21:48health.ec.europa.euEuropean Union

US FDA Finalises Guidance on Using Real-World Evidence for Medical Device Decision-Making

The US FDA has finalized guidance on utilizing Real-World Evidence (RWE) to support regulatory decisions for medical devices, clarifying standards for data relevance and reliability. This update enables manufacturers to leverage diverse data sources for faster market access and post-market compliance, provided they meet rigorous new methodological benchmarks.

18 Dec 2025, 13:11federalregister.govUnited States

ANSES Monitors Adverse Effects of Vector Control Insecticides (Vigil'Anses N°27)

ANSES has intensified toxicovigilance monitoring for vector control biocides, focusing on acute adverse effects from deltamethrin and Bacillus thuringiensis during active mosquito seasons. Enhanced real-world safety data collection may trigger future regulatory reviews, potentially impacting labeling requirements or authorized use patterns for pyrethroid and biological insecticides.

11 Dec 2025, 18:47vigilances.anses.frFrance