Egyptian Drug Authority



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Announcements


Approval of the minister of health to extend the time limits for the fulfillment of the pharmacovigilance requirements (in second submission) provided in the framework of registration of human medicines in accordance with ministerial decree 425/2015

14/08/2017

Suggest Minister Decree of Veterinary Medicines

03/08/2017

Suggested Minister Decree of Herbal Medicines

26/07/2017

Suggested Minister Decree of dietary supplements

26/07/2017

Important announcement regarding technical committee decisions

21/06/2017

Announcement regarding registration of Sofosbuvir + Ledipasvir

18/06/2017

Pharmaceutical Track and Trace Implementation Timeline

11/06/2017

Important announcement regarding technical committee decisions

22/05/2017

Names Update till 27/4/2017

02/05/2017

Important announcement regarding technical committee decisions

27/04/2017

New announcement regarding technical committee decisions

24/04/2017

Checklist for cosmetics GMP

18/04/2017

Change reception time of submitting naming list next Monday

13/04/2017

Dead time of submitting naming list

13/04/2017

Ministerial Decree no. 29/2016 regarding the Pharmaceutical Track and Trace

09/04/2017

GTIN, GLN Database Development by 1 May 2017

09/04/2017

Egyptian OTC list 2017

06/04/2017

Important Announcement

06/04/2017

Important announcement regarding technical committee decisions

13/03/2017

List of open boxes of Human Parenteral solutions

09/03/2017

Sops of registration of sofobuvir + velpatsvir ( over the box)

02/03/2017

Form of Medical Device Custom Clearance starting from (1/4/2017)

23/02/2017

Important announcement regarding technical committee decisions

23/01/2017

Important Letters for distributer, importer & production companies

23/01/2017

Final draft for the Egyptian guidelines for registration of herbal medicines

19/01/2017

Important announcement regarding technical committee decisions

11/01/2017

Imp. announcement regarding technical committee decisions

25/12/2016

Imp. announcement regarding technical committee decisions

27/11/2016

Currency Plan Template

19/10/2016

Currency Plan

17/10/2016

Expediting appointments for pharmaceutical products submitted for re registration submitted according to minister decree 425/2015

13/10/2016

Parenteral Infusion Follow up

22/09/2016

Imp. announcement regarding technical committee decisions

20/09/2016

Important announcement regarding technical committee decisions

10/08/2016

RE-registration according to minister Decree 425

03/07/2016

Oncology Products New Registration Announcement

20/06/2016

Imp. Announcement regarding price increase instructions

31/05/2016

Updated Pricing List

30/05/2016

Announcement regarding price increase instructions

18/05/2016

Announcement regarding surgical gloves and local factories

10/05/2016

Company Profile Announcement

03/05/2016

Updates to technical committee decisions related to medical devices

18/04/2016

Announcement regarding registration of medical devices

06/03/2016

Minister Approval of Opening the Sofospovir+ Ledipasvir box 1-2-2016

01/02/2016

Biannual statstical report of the General Directorate of Registration from June 2015 to November 2015

28/01/2016

Important announcement regarding sterile orthopedic medical devices

26/01/2016

Suggested Draft for Herbal Medicine Guidelines

19/01/2016

Suggested Draft for Toll New Requirements

04/01/2016

Submission of soft files for dietary supplements starting from 1-2016

08/12/2015

Announcement regarding Invitro Diagnostic products

26/11/2015

TOLL & UNDER CONSTRUCTION COMPANIES DATA

22/10/2015

New Sops for submission of new request inquiry form acc. To ministerial decree 425/2015

07/10/2015

Technical Committee Warnings on active & in active substances

29/09/2015

Important Announcement Concerning the application of Ministerial Decree No. 425/2015

16/09/2015

Last updated variation checklist

24/08/2015

Final draft of prescription medicine promotion guidelines (Comments are welcome to be received by hand at the office until 15/8/2015)

13/07/2015

Suggested Draft for Reception of Soft Files for Scientific Committee of Dietary Supplements by CDs

07/06/2015

First draft guidelines for Herbal medicine

04/06/2015

Annual Production Plan : Apply Urgent before 30-4-2015

22/01/2015

Important announcement regarding Stability study

04/01/2015

Important Announcement Regarding Medical Device Safety

17/09/2014

New List from Vaccines available for Registration

24/07/2014

Important Announcement Regarding ISO Certificate

04/06/2014

Export and Tender – New System SOPs

26/05/2014

New contacts for veterinary Department

04/05/2014

Impotant Announcement Concerning ISO Certificate 13485

29/04/2014

Important Announcement for Request inquiries submitted according to minister Decree 296/2009 Regards

23/04/2014

Biologicals: Fast Track Guidelines

17/04/2014

Proposal of Dietary Supplement Registration Decree, for Comments from Industry

30/03/2014

Human Reg Announcement

02/02/2014

Important Registration Announcement

16/12/2013

Finally publishing Variation Check List

29/07/2013

Draft for the ministerial decree for the new registration process for human pharmaceutical products.

28/07/2013

Guidelines for Biological submission: New applications Vs Variation

29/05/2013

New Procedure for Submission of Stability Studies

18/11/2009

Guidelines for Minister Decree 296

01/08/2009