19 January 2026
The Egyptian Drug Authority (EDA) – represented by the General Administration of Pharmacovigilance – hereby announces the necessity for the companies listed below to urgently provide their pharmacovigilance (PV) status, in accordance with the following regulations:
First: Submission of Required DocumentsDocuments must be submitted no later than Monday, January 26, 2026 (within 7 working days from the date of this announcement), and shall include:
- Contact details of the company’s Pharmacovigilance personnel, in addition to the contact information of the Chairman of the Board.
- The company’s Pharmacovigilance system status, categorized as follows:
- In case of an In-house PV System:
- An official letter naming the personnel responsible for PV activities.
- The most recent Pharmacovigilance System Master File (PSMF), including all products and their current status.
- In case of Outsourcing (Contracting with a third party):
- A letter specifying the contracted entity (Service Provider).
- A valid and certified Pharmacovigilance Agreement (PVA) outlining the responsibilities of each party and the products covered under the contract.
- In case of an In-house PV System:
- The Company’s Commercial Register, clarifying the Company Profile Number and the Toll Card (if applicable).
Second: References and LinksTo review all requirements for file submission, please refer to the following:
- The Egyptian Good Pharmacovigilance Practice (GVP) Manual (Version 2.0).
- The latest PV Reception Checklist.
Third: Submission MechanismApplications must be submitted via the link:
PV System Reception Link
PV System Reception Link