ボスニア・ヘルツェゴビナ
規制当局 医薬品医療機器庁（ALMBIH） 公式サイト ↗
eCTD v3.2.2 · EU M1
施行中Bosnia and Herzegovina is the first country in its region to implement eCTD. ALMBIH ran a pilot project from 1 August to 31 October 2025 and published the final eCTD Specification for BiH v1.3 (applicant instructions) with its technical package on 4 December 2025. Since 2 February 2026, first registration applications may be filed in eCTD, and the agency's Q&A has since extended to grant, renewal and variation procedures. The specification follows ICH eCTD v3.2.2 together with the EU Harmonised Technical Guidance v6.0.1, EU Module 1 v3.1.1 and EU Regional Validation Criteria v8.2. NeeS remains officially valid, and no mandatory eCTD date has been announced.
Applicants switching from NeeS must file a baseline submission first (covering all previously filed dossier content, envelope marked reformat/none) and cannot return to NeeS afterwards — freeze the dossier state before migrating.
発表と更新情報
よくある質問
Does ALMBIH mandate eCTD now?
No. Since 2 February 2026 eCTD is one of ALMBIH's officially accepted formats and first registration applications may be filed in eCTD; the agency's Q&A now covers grant, renewal and variation procedures. NeeS remains an officially valid format, and no mandatory eCTD date has been announced.
What should I watch out for when switching from NeeS to eCTD?
Under the BiH eCTD Specification v1.3, the first submission after switching must be a baseline submission covering the complete dossier content previously filed in NeeS (or another format), with submission unit type "reformat" and submission type "none" in the envelope. Once the baseline is sent, returning to NeeS is no longer allowed.
Which specification version is BiH eCTD based on?
Per the official specification v1.3 (final, 4 December 2025), BiH eCTD follows ICH eCTD v3.2.2 together with the EU Harmonised Technical Guidance v6.0.1, EU Module 1 v3.1.1 and EU Regional eCTD Validation Criteria v8.2. There is no official v4.0 information yet.