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Regulatory Framework for Drugs Approval

sfda_gov_sa · policy · processed · 65 chunks

date_gregorian=2021-10-17 date_hijri=1443-03-11 document_type=policy entity=format:application/pdf language=en taxonomy_l1=health taxonomy_l2=pharmaceuticals taxonomy_l3=drug_registration validity=valid validity_confidence=0.6

الهييه العامه للغذاء والدواء Saudi Food & Drug Authority SFDA # Regulatory Framework for Drugs # Approval Version 6.3 | | | |---|---| | Date of issue | 15 July 2008 | | Date of implementation | 1 October 2020 | 1 DS-G-001-V6.3/090705 بالاهم نهتم # Regulatory Framework for Drugs # Approval Version 6.3 Saudi Food & Drug Authority Drug Sector Please visit SFDA's website at for the latest update DS-G-001-V6.3/090705 2 بالاهم نهتم # Saudi Food and Drug Authority ## Vision and Mission ### Vision To be a leading international science-based regulator to protect and promote public health ### Mission Protecting the community through regulations and effective controls to ensure the safety of food, drugs, medical devices, cosmetics, pesticides and feed DS-G-001-V6.3/090705 3 بالاهم نهتم # Document Control | Version | Author | Date | Comments | | :------ | :----------------------------------- | :---------------- | :--------------------------------------------- | | 1.0 | Licensing department | 15 March 2008 | Initial draft for internal consultation | | 2.0 | Licensing department | 15 July 2008 | Published for comments | | 3.0 | Licensing department | 19 January 2009 | Revised draft | | 4.0 | Licensing department | 5 July 2009 | Final version posted | | 5.0 | Regulatory Affairs | 16 March 2014 | Update | | 6.0 | Executive Directorate of Regulatory Affairs | 17 March 2019 | Update and published for comments purposes | | 6.1 | Executive Directorate of Regulatory Affairs | 1 September 2020 | Update | | 6.2 | Executive Directorate of Regulatory Affairs | 12 October 2021 | Update | | 6.3 | Executive Directorate of Regulatory Affairs | 23 February 2022 | Update (Next page shows the updated details) | DS-G-001-V6.3/090705 4 بالاهم نهتم # What is New in version no. 6.3? The following table shows the update to the previous version: | Section | Description of change | |---|---| | Glossary | **Update:** <br> Glossary <br> - Stringent Regulatory Authority (SRA) <br> < For human products: <br> USFDA, EMA, MHRA (UK), Swissmedic, Health Canada, TGA (Australia) and PMDA (Japan). | DS-G-001-V6.3/090705 5 بالاهم نهتم # Table of Contents: * ACRONYMS AND ABBREVIATIONS 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