eCTD-Pharma Bosnia

In Bosnia and Herzegovina, the introduction of the eCTD (electronic Common Technical Document) is a central theme in the modernization of ALMBiH (Agency for Medicines and Medical Devices of Bosnia and Herzegovina).

Although the country is not yet an EU member, its roadmap is closely linked to alignment with European regulations (EMA) to facilitate market access and technical harmonization.

Current status and main developments as of 2026:

• Transition Phase (2025-2026): ALMBiH has started accepting dossiers in structured electronic format, encouraging companies to familiarise themselves with the eCTD v3.2.2 standard, which remains the current reference for the non-EU Balkan region.

• Harmonization Objective: By the end of 2026, the requirement for new registrations (MAA - Marketing Authorization Applications) is expected to be strengthened, following the example of neighboring countries such as Serbia and Montenegro, which already have consolidated roadmaps.

• EUAA Support:There is a cooperation plan (Roadmap 2025-2027) between the EU and Bosnia to strengthen national authorities, which indirectly includes improving IT systems for medicines management.

Gruppo SASI is fully prepared to support pharmaceutical companies in this regulatory transition phase.

Thanks to our eCTD-Pharma software, already fully configured for the specifications required by the authorities of Bosnia and Herzegovina, we guarantee smooth dossier management and certified submission, in full compliance with the new local standards.