Veterinary Drugs

Japan Amends Livestock Infectious Diseases Prevention Act And CSF Control Measures

Japan has promulgated a special package of amendments to the Act on Domestic Animal Infectious Diseases Control and related regulations and guidance, including measures on classical swine fever (CSF), via Official Gazette Special Extra No. 26 on 19 May 2026. This package may change legal expectations for livestock disease control and designated veterinary pharmaceuticals in Japan, so producers and suppliers should review the Japanese texts to understand any new obligations.

25 May 2026, 18:20kanpo.go.jpJapan

Sweden Phases In Veterinary Treatment Reporting Under Jordbruksverket Regulation D 36

Sweden’s Board of Agriculture is phasing in mandatory reporting of veterinarians’ medicinal treatments under regulation D 36, starting in October 2025 and extending to more animal species from January 2026. This creates a new compliance workload for veterinary practices and livestock sectors while strengthening surveillance of animal health and antibiotic use for national oversight and EU reporting.

25 May 2026, 17:11jordbruksverket.seSweden

US FDA Seeks OMB Review of Adverse Event Reporting Information Collection for Approved New Animal Drugs

FDA has sent its adverse event reporting information collection for approved new animal drugs (OMB Control No. 0910-0284) to OMB for final review under the Paperwork Reduction Act, with public comments due by 22 June 2026. This extends existing postmarketing safety reporting and recordkeeping requirements for animal drug sponsors and feed manufacturers while confirming significantly higher expected reporting and recordkeeping burdens as product use and associated case volumes grow.

25 May 2026, 15:35federalregister.govUnited States

Japan Food Safety Commission Schedules Closed 214th Fertilizer And Feed Expert Committee Meeting On Pradofloxacin (27 May 2026)

Japan’s Food Safety Commission will hold a closed Fertilizer and Feed Expert Committee meeting on 27 May 2026 to assess the food health impact of the veterinary drug pradofloxacin. This signals an active risk-assessment process whose conclusions may shape future Japanese requirements for pradofloxacin use in food-producing animals and related products.

23 May 2026, 19:50fsc.go.jpJapan

EMA Publishes CVMP May 2026 Agenda With MRL Evaluation Guideline And Immunological Concept Papers

EMA has published the CVMP’s 19–21 May 2026 agenda, highlighting planned adoption of a new guideline on when MRL evaluations are needed for certain biological substances, concept papers to revise key immunological veterinary guidance, and appointment of rapporteurs for a new MRL application. These items signal upcoming changes in how veterinary MRL needs are assessed and how immunological products are developed and authorised in the EU, so veterinary pharma and food supply stakeholders should monitor the meeting outcome for new guidance and future consultations.

20 May 2026, 19:59ema.europa.euEuropean Union

Ukraine Economy Ministry Order No. 5889 Adds Agriculture and Food Safety Projects to 2026 Regulatory Work Plan

In May 2026, Ukraine’s Ministry of Economy, Environment and Agriculture adopted Order No. 5889 updating its 2026 regulatory work plan with new agriculture, veterinary, food safety and business support projects scheduled between May and December. These additions foreshadow upcoming draft measures on animal identification, industrial hemp oversight, veterinary medicines, animal feed controls and fee structures, giving agri-food and veterinary businesses early visibility of areas where rules and costs may change.

20 May 2026, 17:50me.gov.uaUkraine

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 Commission Amends Marketing Authorisation for Veterinary Vaccine PREVEXXION RN (Decision C(2026)3445)

The European Commission has issued Implementing Decision C(2026)3445 amending the EU marketing authorisation for the veterinary vaccine PREVEXXION RN. This change may alter the authorised conditions under which the product can be marketed or used, so authorisation holders and distributors should review the final decision text promptly and adjust compliance and supply planning if required.

20 May 2026, 06:48ec.europa.euEuropean Union

New Zealand Introduces ACVM Amendment Bill To Streamline Agricultural Chemicals And Veterinary Medicines

In May 2026 New Zealand introduced the Agricultural Compounds and Veterinary Medicines (ACVM) Amendment Bill to streamline approvals for agricultural chemicals and veterinary medicines by relying more on trusted overseas regulators and risk-based pathways. If enacted, this will reshape how manufacturers and importers plan registrations for new and lower-risk products, potentially shortening time to market while shifting detailed timelines and requirements into future regulations.

16 May 2026, 08:53beehive.govt.nzNew Zealand

Brazil — SDA/MAPA Ordinance 1.600/2026 Prohibits Human-Reserved Antimicrobials in Food Animals

Brazil has brought into force SDA/MAPA Ordinance 1.600/2026, immediately banning veterinary products for food animals that contain antimicrobial active ingredients reserved for human use and tightening controls on highest-priority critically important antimicrobials. This significantly narrows the toolbox for livestock and aquaculture treatments, forcing companies to review product portfolios, registrations, import flows and prescribing protocols in Brazil in light of stricter antimicrobial resistance and export-market expectations.

15 May 2026, 09:40members.wto.orgBrazil

France Evaluates Network Of Veterinary Antibiotic Stewardship Advisors Under Écoantibio Plans

France’s agriculture ministry inspectorate has issued a non-binding evaluation of the Écoantibio veterinary antibiotic-referent network, finding that the existing structure, funding and IT tools are too weak and invisible to fully support prudent antibiotic use in animal health. If adopted, its recommendations would strengthen policy focus and multi-year funding for veterinary antimicrobial stewardship and digital decision-support tools, signalling continued regulatory pressure on responsible antibiotic prescribing rather than new immediate legal obligations.

14 May 2026, 19:27vie-publique.frFrance

EU Adopts Delegated Regulation 2026/1073 Updating Veterinary Vaccination Rules for Listed Animal Diseases

Commission delegated regulation 2026/1073, published in May 2026, tightens and clarifies EU rules on when and how veterinary vaccines and other veterinary medicinal products may be used to prevent and control major listed animal diseases, and how vaccination zones are managed. Member States and animal health operators will need to update vaccination plans, surveillance strategies, product use conditions and movement controls for species affected by FMD, HPAI, ASF, CSF, lumpy skin disease and sheep/goat pox in line with the new annexes and waiting-period rules.

14 May 2026, 09:33eur-lex.europa.euEuropean Union

Norway Implements EU Veterinary Variations Regulation (EU) 2025/163 via EEA Agreement

Norway has notified that Commission Implementing Regulation (EU) 2025/163 on veterinary marketing-authorisation variations not requiring prior assessment has been incorporated into the EEA Agreement and implemented in Norwegian law, following a 2025 national consultation, an EEA Joint Committee decision on 30 April 2026, and entry into force in Norway on 1 May 2026. For veterinary marketing authorisation holders in Norway and the wider EEA, this confirms that the updated EU variation categories and conditions—covering certain manufacturing, quality and product-information changes, including those linked to Delegated Regulation (EU) 2024/1159—now apply under Norwegian rules, reducing administrative burden but requiring alignment of planned changes with the revised annex.

13 May 2026, 19:31eur-lex.europa.euEuropean UnionEuropean Economic AreaNorway

EU Amends Veterinary Medicines Variation Rules to Add Distributor Contact Details as Non-Assessed Change

Commission Implementing Regulation (EU) 2026/758, in force from late April 2026, updates the veterinary medicines variation list so that changes to distributor contact details are treated as non-assessed, purely administrative variations. This eases minor labelling updates for veterinary marketing authorisation holders without altering underlying quality, safety, or pharmacovigilance obligations, signalling incremental streamlining rather than a substantive regulatory shift.

13 May 2026, 19:28eur-lex.europa.euEuropean UnionNorway

Colombia Draft Resolution to Implement Andean Decision 960 on Veterinary Products

Colombia has notified a draft resolution to the WTO to implement Andean Community Decision 960 and its Technical Manual, establishing harmonised rules for the registration, renewal and control of veterinary products. Veterinary drug and disinfectant manufacturers and distributors serving Colombia and the wider Andean market should prepare for tighter, standardised registration and oversight requirements by 30 September 2026, reviewing product portfolios, dossiers and quality systems against the new regional framework.

13 May 2026, 19:15track.pstmrk.itColombia

Lithuania VMVT Adopts 2026 Dairy Cow Mastitis Antimicrobial Resistance Monitoring Programme

Lithuania’s State Food and Veterinary Service has adopted a 2026 surveillance programme for mastitis pathogens in dairy cows and their susceptibility to antimicrobials, with binding rules on sampling, laboratory testing, farmer responsibilities and EUR 83,000 in dedicated funding, effective from May 2026. This significantly reinforces antimicrobial resistance monitoring and stewardship expectations in the Lithuanian dairy sector, tightening oversight of antibiotic use, data reporting and milk quality management for producers and accredited laboratories.

13 May 2026, 11:53e-tar.ltLithuania

Colombia (ICA) Drafts Resolution on Good Manufacturing and Storage Practices for Veterinary Products (G/SPS/N/COL/421)

Colombia’s agricultural authority has proposed a new GMP and storage certification regime for companies manufacturing or warehousing veterinary medicines and related products, with application planned from October 2026. If adopted, this will raise compliance expectations for veterinary supply chains and importers, aligning national controls with updated Andean veterinary standards and introducing time-bound certification and transition obligations, including a 2031 deadline for biologicals.

12 May 2026, 13:05members.wto.orgColombia

US FDA Seeks Stakeholder Participation in AGDUFA Reauthorization Consultation Meetings

FDA has opened stakeholder consultation meetings to inform reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), asking organisations to register representatives by 1 June 2026 to participate in recurring discussions with the Agency and industry. Generic animal drug sponsors and veterinary stakeholder groups should consider engaging early in this process to shape future user fee commitments and review resources before the current AGDUFA IV authority expires in 2028.

11 May 2026, 12:05federalregister.govUnited States

Missouri SB1724 Referred to Judiciary Committee; Would Classify Xylazine as Schedule III Controlled Substance

Missouri’s SB1724 would classify the veterinary sedative xylazine as a Schedule III controlled substance while preserving specified authorised animal-health uses, and it has advanced to the Senate Judiciary and Civil and Criminal Jurisprudence Committee in May 2026. If enacted, manufacturers, distributors, veterinarians, and pharmacies operating in Missouri would face tighter controls and monitoring around xylazine, so they should begin assessing supply chains, prescribing practices, and diversion-prevention measures in anticipation of possible passage.

9 May 2026, 14:24senate.mo.govUnited States

Ukraine Draft Cabinet Resolution on Fee Methodologies for Evaluation of Veterinary Medicinal Product Registration Dossiers and Changes

Ukraine’s Ministry of Economy has released a draft Cabinet resolution to formalise methodologies for calculating fees charged for evaluating veterinary medicinal product registration dossiers and subsequent registration changes, now open for public input as of early May 2026. If adopted, this will clarify and potentially adjust cost structures for companies seeking to register or vary veterinary medicines in Ukraine, affecting budgeting, pricing and market-access planning for animal-health portfolios.

8 May 2026, 06:55me.gov.uaUkraine