Yibeltal Abeje Melese-YAM

Yibeltal Abeje Melese-YAM -Informations about drug registration, GMP inspection, QC test will be delivered.
-Technical support

Committee 4😁😁😁
30/07/2024

Committee 4😁😁😁

30/07/2024
30/07/2024
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14/07/2023

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For pharmaceutical Companies:
04/11/2022

For pharmaceutical Companies:

Reminder for pharmaceutical companies: GMP Audit
18/07/2022

Reminder for pharmaceutical companies: GMP Audit

IGAD Membere states
30/08/2021

IGAD Membere states

10/03/2021

5th IGAD Joint Assessment will be started on first week of April 2021

For IGAD joint medicine assessment:
The applicants should submit:
1. A complete CTD(Module 1, 2, 3, 4, & 5) dossier in PDF(appropriately compiled) (ICH).
2. In addition Module 2 in MS words(QOS/QIS).
3. Product information summary(QIS + BTIF) in MS words.
4. The actual product sample/color photo for visual evaluation.
5. Written consent form(sealed, signed & dated).

QIS= Quality information Summary
BTIF=Bioequivalence Trial Information Form
QOS=Quality overall summary

19/02/2021

The 4th IGAD Joint Medicine Dossier Assessment is on progress. Three full assessment, six SRA Route and three FIRR are undergoing the evaluation. May be five FIRR will be extended to the next round!

16/01/2021

IGAD 4 th Joint Medicine assessment is on going.
15 Jan. 2021 to end of Feb. 2021.

Address

Addis Ababa

Telephone

+251913930289

Website

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