New development
EMA and AMA clarify evidence for Bundibugyo vaccine trial
EU / Africa · pharmacy, clinical trials and laboratories · international strategic signal - regulatory guidelines
On 23 October, the EMA and the African Medicines Agency (AMA) announced a joint position on the clinical development of Bundibugyo virus vaccines. The document EMA/228242/2026 addresses the minimum evidence for entry into trials, the use of data from previously studied platforms and the planning of subsequent phases. This is regulatory guidance and not a vaccine-specific authorisation or a general exemption from studies. Developers, research organisations and laboratories must justify the applicability of previous data, safety and the chosen trial design. Early consultation with the relevant regulators remains necessary, especially in the event of deviations from the considered platforms and approaches.
Upcoming deadlines
Machines: seven days until the end of the Bulgarian consultation
Bulgaria / EU · machinery and conformity assessment · consultation — reminder T–7
The public consultation on the draft new regulation on the essential requirements and conformity assessment of machinery ends on 31 October 2026. Today's alert is a T-7 reminder for the procedure opened on 1 October, and not a newly adopted change. The draft regulates the national implementation of Regulation (EU) 2023/1230, including the authorisation of conformity assessment bodies. The proposed general date of entry into force is 20 January 2027, with separate earlier authorisation provisions. Manufacturers, importers and assessors must check the transitional conditions and application documents and submit specific, evidence-based opinions within the remaining period.
Pesticides: consultation on inspections, laboratory methods and reporting
Bulgaria · agriculture, laboratories and technical control · consultation — first public inclusion in T–30
The Ministry of Agriculture and Food is accepting comments on the updated National Action Plan for the Sustainable Use of Pesticides until 23 November 2026. The draft was published on 22 October and today reaches T–30; this is its first public inclusion in the review. The plan addresses checks on equipment used, control indicators and the expansion of the analytical scope through the development and validation of methods. Farmers, testing centres and laboratories should assess the measurability of the objectives and the necessary resources. It is important to distinguish between already existing obligations and the proposed measures and indicators until 2030; the consultation itself does not introduce new requirements.
USA: 30 days for opinions on the safety of blind cords
USA / exporters · consumer products, testing and market access · consultation — reminder T–30
The U.S. CPSC is accepting comments on a draft to supplement the list of significant product hazards for cords in blinds and other window coverings through November 23, 2026. The document, published on September 24, has reached T–30 and is not yet a final rule. The proposals address accessible free-hanging cords, certain loops, retractors, and warnings for specific product configurations. Manufacturers and exporters to the United States must compare their models to the proposed criteria and the referenced ANSI/WCMA A100.1-2022 standard. The practical preparation includes measurements, verification of cord accessibility, and documented technical opinions, but is not intended to change the current rules.
FDA: Deadline for comments on limited approach to food traceability
USA / International Food Chains · Food, Traceability and Evidence · Draft Guidance — Reminder T–30
The comment period for FDA to consider before preparing final guidance for certain small food and restaurant establishments expires on November 23, 2026. The October 9 draft reached T–30 and describes a limited approach to implementing the requirements for additional traceability records. It does not override the general rule and does not automatically exempt manufacturers, exporters, or all suppliers. Affected establishments should review the categories of activities and financial criteria, and their partners should review which batch data they continue to exchange and store. The document is a draft of non-binding guidance; comments on the guidance may be submitted after the procedural deadline.
Strategic Watch
The draft for the new agricultural agency specifies the continuity of documents
Bulgaria · seed control, laboratories and certification · consultation - new draft decree
On October 23, the Ministry of Agriculture and Food published a separate draft decree and organizational regulations for the Executive Agency for Selection and Reproduction in Agriculture. The consultation ends on November 23. Unlike the already reflected draft law on seed material, this text describes the organizational transformation and transition of administrative proceedings. It is envisaged that the issued acts, certificates and document templates will remain valid until their expiry date, and the initiated proceedings will be completed according to the current procedure. The proposed date is January 1, 2027, no change has occurred. Seed producers, laboratories and inspectors should check the continuity of permits and documentary flows.
The Forestry Project Includes New Texts for Fisheries Inspections
Bulgaria / EU · fisheries, inspections and metrology · consultation - draft law
The draft amendment to the Forestry Act, published on 23 October, which also contains changes to fisheries control, is being discussed until 6 November 2026. These include explicit powers to use measuring instruments under the Measurements Act, checking on-board tracking equipment and access to premises subject to inspection. Obligations for safe access and cooperation from operators are also proposed. This is a draft law with a proposed date of 1 January 2027, not a regime already in place. Fishing enterprises and control teams should check the practical feasibility, metrological evidence and inspection procedures before submitting opinions.
Published by MG Global in partnership with ERPI.
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