New development
FDA finalizes guidance on prescription drug-related software
USA · Pharmacy and Digital Health · Final Non-Binding Guidance
The FDA published its final guidance on prescription drug software on October 20, with a notice in the Federal Register dated October 21. The document explains when results presented to the patient or healthcare professional are considered part of the drug information and when they are submitted for regulatory review. Drug sponsors and their software partners are affected, including for combination products. The guidance is non-binding and does not create a new general deadline. Teams should align the intended use, on-screen messages, and description in the prescribing information with the product file; separate requirements for medical software do not apply.
Diphenidine enters Schedule I of the United States on October 21
United States · Laboratories, Research and Chemicals · Final Rule Effective Date
On October 21, the DEA’s final rule to add diphenidine to Schedule I of the U.S. controlled substance regime will take effect. The act was published on September 21; the new development marks the beginning of its operation. Affected laboratories, researchers, and suppliers in the U.S. must verify their registration, storage security, inventory, and reporting. Researchers who are already working with diphenidine and are registered for research with another Schedule I substance as of October 21 may conditionally continue with a complete application within 90 days. This is not a general grace period and does not authorize distribution. European partners should verify the eligibility of the U.S. recipient prior to shipment.
Upcoming deadlines
T–30: Type IA submissions to EMA to be completed in 2026.
EU · Pharmacy · Operational reminder — T–30
There are 30 days left until 20 November, the EMA deadline for submitting annual updates of type IA, individual variations IA and IAIN and consolidated submissions, where a result is expected by the end of 2026. This is a reminder of the operational timetable published on 1 October and not a new regulatory deadline. Later applications will be processed, but the result may be issued in January 2027. Holders of centralised authorisations should check the completeness of the documentation, the correct grouping and internal approvals. EMA clarifies that the dates are indicative and depend on the volume and complexity of the submissions.
Strategic Watch
EU defines its position on ES-TRIN 2027/1
EU and European inland waterways · Shipping, inspection and technical certification · EU position adopted - strategic signal
Decision (EU) 2026/2357 published on 21 October sets the EU's support for ES-TRIN 2027/1 and the date of application as 1 January 2028. The standard covers technical requirements for river vessels, equipment, identification and model certificates. This is an adopted position of the Council and not the text of the standard itself or an automatically introduced new obligation for shipowners. The signal for Danube operators, shipyards and inspection bodies is to plan a review of the technical files and transitional rules. Before changing the checklists, the final standard and the acts making it applicable in the relevant regime should be checked.
ES-RIS 2027/1 outlines the next stage of river interoperability
EU and European inland waterways River information services and equipment EU position adopted - strategic signal
With Decision (EU) 2026/2357, published on 21 October, the EU also supports ES-RIS 2027/1, the separate standard for river information services, with a target date of 1 January 2028. The scope includes electronic navigational charts, ship reporting, notifications to drivers, tracking and equipment compatibility. The signal is strategic for digital system providers, administrations and testing teams: future compatibility must be traceable to a specific version of the specifications. The decision defines the European position and does not replace the final standard or the applicable legal acts. Organisations can start an inventory of interfaces and test evidence without assuming that the new rules are already mandatory.
Measures for access of external AI services to Android have been published
EU · Digital products, AI and interoperability · Officially published summary of adopted decision
On 21 October, the Official Journal published a summary of the Commission's decision of 16 July in case DMA.100220 on Android. It specifies Alphabet's obligations for effective interoperability of external AI services with activation, context, integration and resource functions. Most measures must be implemented with Android 18, at the latest by 1 August 2027; for simultaneous voice activation of multiple services, the deadline is 1 August 2028. Security, privacy and access admissibility guarantees remain. Developers should follow the specifications and plan interface tests. This is not a general AI certification scheme.
Published by MG Global in partnership with ERPI.
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