Real-World Data (RWD)

German Government Submits Draft Medical Registers Act to Strengthen Registries and Data Use

In May 2026 the German government submitted a draft Medical Registers Act that would create a central registry framework, new quality criteria and data-sharing rules for medical registries, and align Social Code Book V and implant registry law around use of the health insurance number for pseudonymised data linkage. If enacted, medtech, pharma and health-data stakeholders running or relying on registries in Germany will face stricter qualification and governance requirements but also easier, more legally secure access to high-quality real-world data for safety, reimbursement and innovation decisions.

15 May 2026, 16:12dserver.bundestag.deGermany

Brazil ANVISA Implements Active Pharmacovigilance Plan for GLP-1 Injection Pens

Brazil’s medicines regulator ANVISA has started implementing an active pharmacovigilance plan for GLP-1 “weight-loss” injection pens, piloting hospital-based real-world data monitoring of drugs such as semaglutide, liraglutide, dulaglutide and tirzepatide. This signals intensified scrutiny of GLP-1 supply and off-label use, so manufacturers, importers and healthcare providers should expect stronger safety reporting expectations, more inspections, and targeted rule changes around GLP-1 products.

4 May 2026, 20:02gov.brBrazil

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

The Dutch government has declined to launch a national long-term study on occupational pesticide exposure, choosing instead to rely on international research and upcoming domestic advisory opinions. This decision signals a move toward using existing global evidence to potentially expand national compensation schemes for pesticide-related health conditions like Parkinson's disease.

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 proposed regulatory amendments in March 2026 to streamline medical device approval pathways and extend transition periods for product modifications. These changes will lower administrative barriers and accelerate market access by expanding the acceptance of real-world evidence and simplifying documentation for global manufacturers.

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

US FDA Publishes FY 2024 GDUFA Science and Research Report

The US FDA has published its FY 2024 GDUFA report outlining scientific advancements that will define 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 development pipelines to mitigate approval risks and accelerate market access.

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 Department of Veterans Affairs has released its 2025 biennial report on toxicant exposure at the K2 air base, finding no elevated health risks despite the presence of background-level depleted uranium. This data will serve as the scientific foundation for upcoming rulemaking to expand disability benefit eligibility 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 overhaul its public health reporting regulations, introducing expanded disease surveillance and mandatory electronic data submission for healthcare facilities by April 2026. Impacted organizations must prepare for increased reporting obligations and infrastructure updates to support real-time data transmission and compliance with new sentinel surveillance 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 a new expert consensus framing 24-hour light exposure as a critical health determinant, initiating a push for standardized measurement and research. This focus on metrology and dose-response data signals a long-term trajectory toward stricter occupational exposure limits and enhanced monitoring requirements 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 a unified monitoring system to consolidate real-time adverse event reporting across all regulated product categories by May 2026. This transition to immediate public transparency heightens reputational and litigation risks, necessitating proactive internal monitoring of safety signals 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

The Centers for Medicare and Medicaid Services has finalized the OASIS-E2 assessment framework and will mandate automated data submission starting April 2026. Home health providers must overhaul data management workflows and software integration to ensure uninterrupted compliance with federal quality reporting and reimbursement requirements.

10 Mar 2026, 11:28cms.govUnited States

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

The Council has released the four-column negotiation table for the new EU Pharmaceutical Directive, signaling the final stages of interinstitutional trilogues to modernize the medicinal products framework. Companies should prepare for significant changes to market exclusivity, environmental risk assessments, and streamlined authorization pathways that will reshape product lifecycle management and market access strategies.

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 harmonized global standards for using real-world data in non-interventional safety studies for medicines and biological products. This alignment streamlines post-marketing safety assessments across jurisdictions and accelerates the transition toward standardized, data-driven evidence for drug monitoring and market access.

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 postapproval safety reporting standards to include data from social media, market research, and patient support programs. Companies must update pharmacovigilance systems to capture and process these diverse real-world data sources to maintain global compliance and ensure robust product safety monitoring.

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

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

The US CDC is extending the National Firefighter Registry for Cancer data collection through 2028 to monitor occupational health risks and cancer incidence. This longitudinal data will likely underpin future occupational safety standards and stricter risk-reduction policies regarding hazardous substance exposures in firefighting.

27 Feb 2026, 14:54federalregister.govUnited States

Germany: BfR Launches German Poisoning Registry (DVR)

Germany has launched the German Poisoning Registry to centralize nationwide poisoning incident data for enhanced 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 Office for Product Safety and Standards has determined that current national health data lacks the detail required for effective product safety surveillance. This finding signals a likely shift toward more granular data collection and enhanced market surveillance to better identify and mitigate product-related injury risks.

18 Feb 2026, 20:44gov.ukUnited Kingdom

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

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

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

EMA Publishes Veterinary Union Pharmacovigilance Database Best Practice Guide

The EMA has introduced a new best practice guide for the Veterinary Union Pharmacovigilance Database, establishing updated standards for signal management and adverse event reporting. Marketing authorization holders must align their internal data workflows and IT system usage with these technical expectations to ensure continued 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 framework to formalize the integration of new approach methodologies and real-world data into risk assessments. This standardized methodology will increase the transparency and predictability of scientific opinions that underpin future chemical restrictions and consumer product safety standards.

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