Ennov InSight 7.2 Data Migration Documentation

Verify Migration Script Updates

After the migration script is run, changes must be verified and updated to the Data Administration data.

The script includes following updates:

  • Updates ZA region to have the ZA code value in the database.
  • Updates Health Authority Name to South African Health Products Regulatory Authority, Health Authority Abbreviation to SAHPRA, Health Authority eCTD Code to ZA-SAHPRA and Health Authority Website to https://ectd.sahpra.org.za/index.html in Application Maintenance > Country Values Data Administration list.
  • Adds the ZA-3-1 assembly DTD type in the Assembly > Assembly DTD/Schema Types Data Administration list, if it does not already exist.
  • Activates National ZA Procedure Type in the Application Maintenance > Procedure Type Values Data Administration list and adds the National eCTD code value to it.
  • Updates Application Maintenance > Application Type Values with the following values and the corresponding eCTD codes assigned to them:
    • SAHPRA National Procedure
    • AMA Procedure
    • ZAZIBONA Joint Review
    • WHO-PQ
    • WHO SRA CRP
    • Swissmedic MAGHP
    • EU M4ALL
  • Updates Sequence Maintenance > Filing Type Values with the following values and the corresponding eCTD codes assigned to them:
    • A - NCE New Chemical Entit
    • D - New Generic Medicine
    • Complementary Medicine - New
    • New Biological
    • Biosimilar (na-bs)
    • Clinical Trial Application
    • New Vaccines
    • I: Vaccine Antigen Master File
    • New SMF
    • New APIMF
    • Plasma Master File (PMF)
    • Line extension-New Strength
    • Line extension-New Dosage Form
    • Line extension-New Application
    • Clone
    • Replica-Same
    • Type IA-Quality
    • Type IAin-Clinical
    • Type IAin-Quality
    • Type IB-Clinical
    • Type IB-Quality
    • Type I-Inspectorate
    • Type I-Other
    • Type II-Safety (Clinical)
    • Type II - Safety and Efficacy (Clinical)
    • Type II-Quality
    • Type II-Rescheduling
    • Type II-Proprietary Name Change
    • Type II-Change in Applicant-Relinquishing
    • Type II-Change in Applicant-Acquiring
    • Baseline
    • z-Code-Quality
    • Pharmacovigilance
    • USRN-Clinical and Pharmacovigilance
    • Application Withdrawal/Cancellation
    • Renewal Filing
    • Undefined Regulatory Activity*
    • Type lB-Related Clinical
    • Type lB-Related Quality
    • Type lB-Related Inspectorate
    • Type IA-Clinical
    • Type ll-Related Clinical
    • Type ll-Related Quality
    • Type ll-Related Inspectorate
  • Updates Submission Maintenance > Sub Filing Type Values with the following values and the corresponding eCTD codes assigned to them:
    • Initial
    • Supplementary Information
    • Response-Clinical
    • Response-Quality
    • Response-Inspectorate
    • Response-N and S
    • Closing Information
    • Work Grouping Partial Withdrawal
    • Submission Withdrawal
    • Response-Biological
    • Response-Renewals
    • Response-PV
  • Updates Submission Maintenance > Regulatory Activity Lead Values with the following values and the corresponding eCTD codes assigned to them:
    • Biologicals
    • Complimentary
    • Master Files
    • Orthodox
    • Pharmacovigilance
    • Veterinary
  • Updates Submission Maintenance > Evaluation Pathway Values with the following values and the corresponding eCTD codes assigned to them:
    • Priority
    • Full Evaluation
    • Abridged Evaluation
    • Rolling Review
    • Section 21
  • Updates Submission Maintenance > Applicant Contact Type Values with the following values for South Africa and the corresponding eCTD codes assigned to them:
    • Local Applicant
    • Regulatory
    • Technical
    • Product Information
    • General