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The Regulatory Reference of the Egyptian Drug Authority (EDA)

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TRS 1025 Annex 8

Points to consider for setting the remaining shelf-life of medical products upon delivery

WHO 2020 Points to consider for setting the remaining shelf-life of medical products upon delivery

TRS 1025 Annex 7

WHO Technical Report Series, no. 1025: Good storage and distribution practices for medical products

WHO 2020

Good storage and distribution practices for medical products

TRS 1025 - Annex 5

Quality management system requirements for national inspectorates

WHO 2020 Quality management system requirements for national inspectorates

TRS 1011 Annex 3

WHO Technical Report Series, no. 1011: Guidelines on procedures and data requirements for changes to approved biotherapeutic products

WHO 2018

Guidelines on procedures and data requirements for changes to approved biotherapeutic products

TRS 1010- Annex 10

(WHO) Technical Report Series, No. 953, 2009

Stability testing of active pharmaceutical ingredients and
finished pharmaceutical products

WHO 2018 Stability testing of active pharmaceutical ingredients and
finished pharmaceutical products

TRS 1010 - Annex 9

WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

WHO 2018 WHO good practices for desk assessment of compliance with good manufacturing practices, good laboratory practices and good clinical practices for medical products regulatory decisions

TRS 1010 Annex 2

WHO good manufacturing practices for the manufacture of herbal medicines

WHO 2018

WHO good manufacturing practices for the manufacture of herbal medicines

TRS 1010 Annex1

WHO good manufacturing practices for the manufacture of herbal medicines

WHO 2018

WHO good manufacturing practices for the manufacture of herbal medicines

TRS 996 - Annex 4

WHO guidance on good manufacturing practices: Model inspection report

WHO 2016

WHO guidance on good manufacturing practices: Model inspection report

TRS 993 Annex 4

WHO Technical Report Series, no. 993: Guidelines on procedures and data requirements for changes to approved vaccines

WHO 2015

Guidelines on procedures and data requirements for changes to approved vaccines

TRS 992 - Annex 4 

General guidance on hold-time studies

 

WHO 2015 General guidance on hold-time studies

TRS 992 Annex 5

Technical supplements to Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

WHO 2015 Technical supplements to Model guidance for the storage and transport of time- and temperature–sensitive pharmaceutical products

TRS 992 Annex 9

WHO Technical Report Series, no. 992: TRS 992 Annex 9 Good review practices: guidelines for national and regional regulatory authorities

WHO 2015

General guidance on hold-time studies

TRS 986 Annex2

WHO good manufacturing practices for pharmaceutical products: Main principles

WHO 2014 WHO good manufacturing practices for pharmaceutical products: Main principles

TRS 961 - Annex 14

WHO guidelines for drafting a site master file

 

WHO 2011 WHO guidelines for drafting a site master file

TRS 961 Annex9

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

WHO 2011

Model guidance for the storage and transport of time and temperature sensitive pharmaceutical products

TRS 961 Annex 6

WHO good manufacturing practices for sterile pharmaceutical products

WHO 2011 WHO good manufacturing practices for sterile pharmaceutical products

TRS 957 - Annex 2

WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)

WHO 2010 WHO good manufacturing practices for active pharmaceutical ingredients (bulk drug substances)

TRS 957 Annex 3

WHO good manufacturing practices for pharmaceutical products containing hazardous substances

منظمة الصWHOحة العالمية 2010 WHO good manufacturing practices for pharmaceutical products containing hazardous substances

TRS 885 Annex5

WHO good manufacturing practices for the manufacture of pharmaceutical excipients

WHO 1999 WHO good manufacturing practices for the manufacture of pharmaceutical excipients

WHO – guideline for safe disposal of unwanted pharmaceutical 

WHO 1999

guideline for safe disposal of unwanted pharmaceutical

TRS 823 - Annex 2

Inspection of pharmaceutical manufacturers

WHO 1992

Inspection of pharmaceutical manufacturers

WHO- management of waste from immunization campaign activities guideline

WHO 2004

management of waste from immunization campaign activities guideline

TRS 902 - Annex 7

WHO guidelines on pre-approval inspections

 

WHO 2002

WHO guidelines on pre-approval inspections

الدليل الإرشادى الخاص بوزارة البيئة بشأن إدارة نفايات الرعاية الصحية فى مصر. WHO 2015 إدارة نفايات الرعاية الصحية فى مصر

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