Healthcare Systems

Indonesia BPOM Issues Regulation No. 5/2026 on Oversight of Medicines Management in Pharmacy Facilities

In March–April 2026, Indonesia’s BPOM adopted Regulation No. 5/2026 establishing binding supervision rules for how medicines and medicinal materials are managed in pharmacy service facilities and certain other facilities. This replaces BPOM Regulation No. 24/2021, so pharmacy operators should update SOPs, training, and records to align with the new oversight framework ahead of inspections.

10 Apr 2026, 15:54jdih.pom.go.idIndonesia

Brazilian Chamber Health Committee Reviews PDPs to Boost National Medicines Production

In April 2026, Brazil’s Chamber Health Committee used a public hearing on PDP partnerships to showcase resumed national production of key medicines and vaccines and to highlight Bill PL 2583/2020, which would create a National Health Strategy and formalise incentives for domestic manufacturers. If PL 2583/2020 advances, Strategic Health Enterprises (EES) could gain a 20‑year special tax regime and up to 10% bid preferences in public procurement, strengthening the business case for locating high‑tech pharmaceutical production and PDP-based technology‑transfer projects in Brazil.

10 Apr 2026, 15:36portalmt.com.brBrazil

Oregon Enacts HB 4069 Requiring Behavioral Health Employer Safety Policies

Oregon has mandated new physical safety requirements for behavioral health employers contracting with the state, effective July 2027. Affected entities must formalize lone-worker protections and structural security protocols to mitigate liability and ensure continued eligibility for state-funded service contracts.

4 Apr 2026, 10:28olis.oregonlegislature.govUnited States

Germany BGH Rules Internet Platform Advertising for Medical Cannabis Breaches § 10 HWG

The German Federal Court of Justice (BGH) ruled in March 2026 that internet platforms promoting prescription medical cannabis treatments to the public violate the Therapeutic Products Advertising Act (HWG). This decision reinforces strict limits on digital health marketing, requiring telemedicine and pharmaceutical platforms to overhaul lead-generation and patient-matching workflows to avoid prohibited consumer-facing advertising.

3 Apr 2026, 18:55rechtsprechung-im-internet.deGermany

EU Parliament SANT Committee To Hear Proposal to Amend MDR and IVDR

The European Parliament's SANT Committee will review the Commission's proposal to simplify the MDR and IVDR frameworks on April 14, 2026. This legislative push aims to reduce administrative burdens and improve certification predictability, signaling potential relief for medical device manufacturers facing compliance bottlenecks.

3 Apr 2026, 09:56europarl.europa.euEuropean Union

US NRC Imposes $36,000 Civil Penalty on Metro Cardiovascular Diagnostics

The US NRC has issued a formal order imposing a $36,000 civil penalty on a Missouri-based medical facility for unresolved radioactive material license violations. This action underscores the agency's commitment to escalating enforcement and pursuing debt collection for non-responsive licensees, highlighting the risk of significant financial and legal consequences for compliance failures.

2 Apr 2026, 09:33govinfo.govUnited States

Latvian Saeima Adopts Second Reading Of Pharmacy Law Amendments And Sets Third-Reading Deadline

Latvia has advanced amendments to its Pharmacy Law through the second reading, setting a deadline for final proposals in April 2026. Companies must prepare for potential shifts in pharmaceutical distribution and precursor controls as the legislation nears final adoption.

2 Apr 2026, 07:55titania.saeima.lvLatvia

Japan METI and MHLW Establish Taskforce to Secure Pharmaceuticals, Medical Devices and Medical Supplies Affected by Middle East Situation

Japan has established a joint ministerial taskforce to address supply chain vulnerabilities for pharmaceuticals and medical devices linked to geopolitical instability in the Middle East. Businesses should anticipate increased government scrutiny of supply resilience and potential future measures to ensure the stable availability of critical medical supplies.

1 Apr 2026, 19:46meti.go.jpJapan

UK DHSC Consults On Justifying Non-Medical DEXA Scans for Sports and Wellness Use

The UK is consulting on permitting non-medical DEXA scans for sports and wellness purposes under ionising radiation regulations through June 2026. If approved, commercial providers must implement clinical-grade safety protocols, including equipment maintenance and dose optimization, to manage radiation risks for consumers.

1 Apr 2026, 18:40gov.ukUnited Kingdom

England: Environment Agency Consults On Radioactive Substances Permit Application For GenesisCare Leeds

The UK Environment Agency is consulting on a new radioactive substances permit for a medical facility in Leeds, with comments due by April 29, 2026. This underscores the strict operational permitting requirements for handling radioactive isotopes and the importance of site-specific compliance within the healthcare sector.

1 Apr 2026, 14:42gov.ukUnited Kingdom

Netherlands (RIVM) Publishes Method To Measure Environmental Impact Of Healthcare

The Dutch RIVM has released an enhanced methodology for calculating the environmental footprint of the healthcare sector, targeting greenhouse gas emissions, medicine production, and resource use. This standardized framework signals a shift toward more granular supply chain reporting and environmental accountability for pharmaceutical and medical device manufacturers.

1 Apr 2026, 14:33rivm.nlNetherlands

EU Commission Working Document on Proposal To Amend Directives 2001/18/EC and 2010/53/EU on Genetically Modified Microorganisms and Organ Processing

The European Commission has detailed proposed authorization pathways for organ processing and genetically modified microorganisms under the forthcoming Biotech Act. The shift toward a centralized EU list of authorized technologies signals a move to streamline market access and reduce administrative barriers for medical and biotech operators.

1 Apr 2026, 14:32data.consilium.europa.euEuropean Union

Italy AIFA Classifies Steqeyma (Ustekinumab) In Provisional Reimbursement Class C(nn)

Italy's AIFA has provisionally classified the biosimilar Steqeyma (ustekinumab) in reimbursement class C(nn), effective March 29, 2026. Marketing authorization holders must adhere to strict pricing notification and reimbursement application timelines to prevent mandatory price alignment to the lowest class level.

1 Apr 2026, 14:16gazzettaufficiale.itItaly

European Commission Answer Outlines Availability Obligations for Gene Therapies and Links to Critical Medicines Act Proposal

The European Commission has signaled that upcoming pharmaceutical reforms and the Critical Medicines Act will introduce mandatory supply obligations and collaborative procurement for high-priority therapies. Companies face the risk of losing market protection if products are not made available within three years, necessitating a strategic review of EU-wide launch and distribution plans.

31 Mar 2026, 19:21europarl.europa.euEuropean Union

UK Adopts Human Medicines (Amendment) Regulations 2026 on Vaccination and Pharmacist Compounding

The UK has adopted the Human Medicines (Amendment) Regulations 2026, effective 31 March 2026, to streamline vaccine administration and pharmacist compounding. Businesses should assess updated licensing exemptions for vaccine distribution and ensure compliance with new packaging and labeling standards for bespoke medicines.

29 Mar 2026, 17:26legislation.gov.ukUnited Kingdom

European Parliament Draft Report on Implementation of Europe’s Beating Cancer Plan

The European Parliament's SANT Committee has issued a draft report demanding stricter tobacco controls, mandatory alcohol health warnings, and faster AI medical device approvals under Europe’s Beating Cancer Plan. This signals strong political pressure for upcoming revisions to tobacco, food, and medical device regulations, emphasizing mandatory labelling and streamlined market access for digital health innovations.

29 Mar 2026, 06:31europarl.europa.euEuropean Union

US FDA Proposes Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity and ELISPOT Tests

The US FDA proposed reclassifying tuberculosis cell-mediated immunity and ELISPOT tests from Class III to Class II (510(k)) on March 30, 2026. This shift reduces the pre-market regulatory burden for manufacturers, potentially accelerating market entry for new diagnostic tools while maintaining safety through specific special controls.

29 Mar 2026, 06:29govinfo.govUnited States

Texas HHSC Sets 1 May 2026 Deadline For Updated Human Trafficking Signage In Healthcare Facilities

Texas healthcare facilities must display updated human trafficking awareness signage by May 1, 2026, following recent legislative mandates. Operators should ensure immediate updates to facility postings to meet specific size and content requirements, reflecting broader state-level enforcement of labor and sex trafficking reporting standards.

28 Mar 2026, 20:29content.govdelivery.comUnited States

Rhode Island: Amended Pharmacists, Pharmacies, and Manufacturers, Wholesalers, and Distributors Rule (216-RICR-40-15-1) Effective 12 April 2026

Rhode Island has finalized comprehensive updates to its pharmacy and pharmaceutical distribution regulations, effective April 2026. Manufacturers and distributors must adapt to modernized compounding standards and new operational frameworks for drug redistribution and clinical service delivery.

28 Mar 2026, 20:28rules.sos.ri.govUnited States

Belgium: Flanders Opens OVAM Support For Asbestos-Safe Care Facilities

Flanders has launched a support scheme providing free asbestos certificates and expert removal guidance for care facilities, effective March 30, 2026. This initiative accelerates the regional 2040 asbestos-safe target, signaling tightening compliance pressure for property owners to identify and remediate legacy hazardous materials.

28 Mar 2026, 18:31ovam.vlaanderen.beBelgium