Zimbabwe: MCAZ Announces Transition to eCTD Submissions by 2029
In its Circular No. 23 of 2026, dated 16 October 2026, the Medicines Control Authority of Zimbabwe (MCAZ) announced its plan to transition to electronic Common Technical Document (eCTD) submissions for medicines. Voluntary submissions are expected to begin in Q3 2027, with mandatory implementation planned for Q1 2029.
Indicative Implementation Timeline
Target Date | Planned Milestone |
October 2026 | Development of eCTD specifications |
Q1 2027 | Stakeholder consultation |
Q2 2027 | Pilot system deployment |
Q3 2027 | Voluntary eCTD submissions |
Q1 2029 | Mandatory eCTD submissions |
What This Means for Applicants
Until further notice, applicants must continue to submit CTD dossiers through the existing ZIMDIS portal. The MCAZ is expected to issue further guidance on the technical specifications and implementation requirements.
As a regulatory affairs specialist in the region, AREMA can support you with your regulatory monitoring and help you prepare for this transition to eCTD.
Source: MCAZ official website · Announcement