Medical Countermeasures Strategy

US FDA Issues EUA for Over-the-Counter Dectomax Injectable for New World Screwworm in Dairy Cattle, Horses, Swine, Sheep, and Deer

In May 2026 the US FDA granted an Emergency Use Authorization for over-the-counter Dectomax/Dectomax-CA1 (doramectin injection) to prevent and treat New World screwworm in dairy cattle and to prevent infestations in certain other livestock and deer. The authorization expands treatment options during the ongoing screwworm emergency but imposes strict milk discard and slaughter withdrawal periods, requiring veterinarians, producers, and dairy processors to adjust treatment protocols and residue compliance planning.

20 May 2026, 10:03fda.govUnited States

European Parliament Public Health Committee Endorses EU–Switzerland Health and Mutual Recognition Package

In May 2026 the European Parliament’s Public Health Committee endorsed the draft EU–Switzerland agreements on health security and mutual recognition of medical products, recommending consent for an Agreement on Health and a protocol updating conformity-assessment arrangements. If finalised, the package will integrate Switzerland into EU early-warning, joint-procurement and ECDC structures and streamline mutual recognition for medical devices and pharmaceuticals, reducing duplicative oversight while preserving EU control over core legislation.

9 May 2026, 19:03europarl.europa.euEuropean UnionSwitzerland

European Parliament Committee Amendments On Union Civil Protection Mechanism And Health Emergency Preparedness (Amendments 180–429)

European Parliament health and environment committees have tabled extensive amendments to the draft EU Regulation on the Union Civil Protection Mechanism, sharpening its focus on health emergency preparedness and medical countermeasures as of April 2026. If carried into the final law, these changes would push the EU towards more centralised, long-term procurement, stockpiling and manufacturing capacity for critical medicines, APIs and PPE, reducing third-country dependencies and reshaping how companies plan for future health crises.

28 Apr 2026, 18:25europarl.europa.euEuropean Union

EU Parliament Committees Table Amendments 430–679 to Draft Union Civil Protection Mechanism and Health Emergency Regulation

European Parliament committees have tabled amendments 430–679 to the draft Union Civil Protection Mechanism and health emergency preparedness regulation, sharpening its treatment of CBRN risks, medical countermeasures, Union stockpiles, and the 2028–2034 funding framework. If adopted, these changes would strengthen EU-coordinated prevention, preparedness, and financing for crisis-relevant medical countermeasures and rescEU capacities, signalling more structured stockpiling and procurement frameworks that suppliers and health systems will need to track.

28 Apr 2026, 11:33europarl.europa.euEuropean Union

US FDA Issues Emergency Use Authorizations for Four Animal Drugs to Treat New World Screwworm

The US Food and Drug Administration has issued four Emergency Use Authorizations for animal drug products containing ivermectin, afoxolaner, esafoxolaner, eprinomectin, praziquantel, benzalkonium chloride, polyhexanide and cypermethrin to prevent and treat New World screwworm infestations in cattle, companion animals, birds and other captive wildlife under an existing HHS public health emergency declaration. These EUAs, effective from February and March 2026, materially expand the emergency treatment options available to veterinarians and animal health operators, who should integrate the new authorised products and their specific use conditions into contingency planning, prescribing decisions and pharmacovigilance processes.

23 Apr 2026, 12:36federalregister.govUnited States

US House Introduces SUPER BUGS Act To Develop Global Antimicrobial Resistance Strategy

The US House has introduced the SUPER BUGS Act of 2026 to establish a global strategy for the development and commercialization of medical countermeasures against antimicrobial-resistant pathogens. This initiative signals a shift toward coordinated international funding and streamlined regulatory pathways, creating new market access and partnership opportunities for the pharmaceutical and biotech sectors.

5 Apr 2026, 06:11govinfo.govUnited States

EU HaDEA Announces Prior Information Notice on Long-Term API Stockpiling and Rapid Finished Dose Manufacture

The European Union is launching a 6 million euro pilot project in May 2026 to develop technologies for long-term API stockpiling and rapid pharmaceutical manufacturing. This initiative signals a strategic shift toward advanced shelf-life extension and localized production capabilities to bolster regional supply chain resilience.

4 Apr 2026, 10:30op.europa.euEuropean Union

Netherlands VWS Minister Confirms Structural Funding and Embedding of Pandemic Preparedness Programme

The Dutch government has committed €177 million annually to structurally embed pandemic preparedness into national health policy, focusing on surveillance, acute-care coordination, and medical countermeasure resilience. For life sciences and medical device sectors, this signals long-term investment in strategic stockpiling, supply chain resilience, and scalable production capacity for vaccines and diagnostics.

2 Apr 2026, 10:18zoek.officielebekendmakingen.nlNetherlands

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

Japan has launched a joint ministerial taskforce to mitigate supply chain risks for pharmaceuticals and medical devices stemming from geopolitical instability in the Middle East. Companies should prepare for increased government oversight of supply resilience and potential future mandates to ensure the continuity of essential medical supplies.

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

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

The UK has enacted the Human Medicines (Amendment) Regulations 2026, making pandemic-era vaccine flexibilities permanent and expanding pharmacist compounding rights from March 31, 2026. Pharmaceutical distributors and healthcare providers must review updated licensing exemptions for vaccine redistribution and ensure compliance with new labeling standards for bespoke medicines.

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

Norway Proposes Amendments to Pharmacy, Medicines and Medical Devices Laws to Implement EU Crisis Preparedness Regulations

Norway has proposed legislation to implement EU crisis preparedness rules, introducing mandatory supply chain reporting for medicines and medical devices. Impacted businesses must prepare for enhanced transparency obligations and the formal adoption of EUDAMED notification requirements to mitigate supply chain risks.

29 Mar 2026, 05:58regjeringen.noNorwayEuropean Economic Area

European Parliament SEDE Amendments on Union Civil Protection Mechanism and Health Emergency Preparedness

European Parliament committees are advancing amendments to the Union Civil Protection Mechanism to centralize the procurement and stockpiling of medical countermeasures and CBRN response equipment. Manufacturers of dual-use technologies and medical supplies should prepare for new EU-level capacity mapping and potential pre-registration requirements for emergency response pools.

28 Mar 2026, 09:33europarl.europa.euEuropean Union

Brazil (Anvisa) Dicol Agenda Includes Normative Instruction To Update COVID-19 Vaccine Composition

Brazil’s health regulator is deliberating a new Normative Instruction to update the mandatory composition requirements for COVID-19 vaccines. Manufacturers should anticipate formulation adjustments and regulatory re-submissions to maintain market access and align with updated epidemiological standards.

27 Mar 2026, 18:16gov.brBrazil

EU / France Commission Delivers Comments on Draft Decree on Medicinal Product Shortages (Notification 2025/0795/FR)

The European Commission has formally challenged France's draft decree on medicinal product shortages, signaling potential conflicts between national supply mandates and EU single market rules. Pharmaceutical operators should anticipate revisions to stockholding and distribution requirements as France adjusts the proposal to meet Commission concerns.

27 Mar 2026, 11:57ec.europa.euEuropean UnionFrance

UK Health Security Agency Updates Spikevax Refrigerated Storage Temperature to +2°C to +8°C

The UK Health Security Agency has updated the mandatory refrigerated storage temperature for the Spikevax vaccine to a range of +2°C to +8°C. Organizations must immediately adjust cold-chain logistics and clinical handling protocols to maintain product integrity and ensure regulatory compliance.

27 Mar 2026, 08:28gov.ukUnited Kingdom

EU Council Working Party on Civil Protection To Discuss UCPM-HER Proposal and Stockpiling of Medical Countermeasures

EU Council negotiations are advancing on the UCPM-HER proposal, focusing on centralized crisis support and long-term medical countermeasure stockpiling for the 2028-2034 period. This shift toward coordinated EU-level procurement and stockpiling will redefine market access and supply chain obligations for the pharmaceutical and medical device sectors.

26 Mar 2026, 19:14data.consilium.europa.euEuropean Union

Estonia Appoints First Essential-Service Pharmacies and Wholesalers for Medicine Supply

Estonia has designated the first pharmacies and wholesalers as essential service providers, mandating strict crisis-response and supply continuity obligations from February 2026. Impacted operators must align logistics and risk planning with new 48-hour restoration and 5-day autonomy standards to ensure pharmaceutical supply chain resilience.

26 Mar 2026, 11:44ravimiamet.eeEstonia

Minnesota Department of Health Extends Use of RSV Monoclonal Antibodies Through 30 April 2026

Minnesota has extended the administration period for RSV monoclonal antibodies through April 30, 2026, in response to sustained viral activity and hospitalization risks. Healthcare and pharmaceutical organizations should adjust supply chain logistics and patient outreach to ensure continued access and reimbursement during this extended season.

19 Mar 2026, 10:06health.state.mn.usUnited States

European Commission Opens Call For Evidence On EU Global Health Resilience Initiative

The European Commission has launched a call for evidence to shape its Global Health Resilience Initiative, with feedback accepted until April 2026. This initiative signals a strategic push toward decentralized manufacturing of health products and reinforced global health security, impacting long-term supply chain strategies and market access for the life sciences sector.

18 Mar 2026, 15:57ec.europa.euEuropean Union

Taiwan TFDA Announces 2026 Medical Device Supply Fragility Risk Assessment and Reserve System Tender (Case 115TFDA-MD-028)

Taiwan is initiating a national assessment of medical device supply chain fragility to establish a strategic reserve system starting in 2026. Companies should prepare for increased oversight of supply continuity and potential future obligations to support national healthcare resilience and inventory mandates.

16 Mar 2026, 16:38fda.gov.twTaiwan