1. Saudi Arabia: Veterinary Pharmaceutical Legislations &
26-Jan-12
Saudi Arabia:
Veterinary Pharmaceutical Legislations &
Marketing Authorization Application (MAA)
Presented by:
Maher Aljaser, MHA.
Section Head, Veterinary Products Licensing
Brussels, Belgium June 2016

2. Agenda Introduction Saudi Food & Drug Authority (SFDA)
26-Jan-12
Agenda
Introduction
Saudi Food & Drug Authority (SFDA)
Veterinary Pharmaceutical
Vision and Mission
SFDA Roles and Responsibilities
Drug Approvals

3. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Introduction

4. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Introduction
Cooperation Council for the Arab States of the Gulf (GCC)
Population (2015) 45M
Saudi Arabia accounts for 65% of all drug sales in the GCC region
Locally made pharmaceuticals supply only around 15% of the market
GCC = Similar to EMA

5. fish farming and aquaculture
Animal Resources
Animal type
Numbers
Sheep
17.5 million
fish farming and aquaculture 
99 project
(15,000,000) m³
Goat
6.1 million
Poultry
50 million bird
Camel
1.4 million
beehive
38,878 thousand
(2 milloin ton/year)
Cattle
million 1

6. Specialized Project

7. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
SFDA Timeline
MoH/MoA:
Responsibility-transfer
5/7: Framework final version
8/7: Guidance for submission
Sep/3:
Vet Law
2009
2010
2016
Operation
2003
2006
2008
Saudi Drug Registration system (SDR)
10/3: Royal Decree
15/7:
1st draft of Framework

8. SFDA Vision
To be the leading regional regulatory authority for food, drugs and medical devices with professional and excellent services that contributes to the protection and advancement of the health in Saudi Arabia

9. SFDA Mission
To ensure the safety of food; the safety, quality and efficacy of drugs; and the safety and effectiveness of medical devices, by developing and enforcing an appropriate regulatory system

10. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
CEO
Food Sector
Drug Sector
Medical Device Sector
Shared Services IT

11. Veterinary Pharmaceutical
Drug sector (Vision and mission)
Law & Legislation
Organogram
Roles & Responsibilities
Product Registration
Website

12. 26-Jan-12
Vision
To be the leading regional Drug Regulatory Authority for pharmaceuticals and cosmetic products, with professional excellence and services that contribute to the protection and advancement of public health in the Kingdom of Saudi Arabia

13. 26-Jan-12
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human and veterinary drugs and biological products, and safety of cosmetics, through administration of a national regulatory system which is consistent with international best practice. 

14. Legislations Law of the General Food and Drug Authority
Executive Guidelines for Law of Veterinary Pharmaceutical for Gulf Council Countries(GCC)
Law of Veterinary Pharmaceutical for Gulf Council Countries(GCC)
Law of Pharmaceutical Establishments and preparation
Law of the General Food and Drug Authority

15. Inspection & Enforcement
26-Jan-12
Organogram VP
Licensing
Evaluation
Pharmacovigilance
Laboratory
Inspection & Enforcement
Cosmetics Safety
NDPIC

16. Core Functions Licensing Cosmetics Safety EB Drug Information
Products Evaluationا
CT, CRO and Blood Bank
Inspection ,
Surveillance &
Enforcement
Lab
Analysis
Pharmaco-vigilance

17. Product Registration Product Registration: Guidelines e-Services

18. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12

19. Regulatory Framework for Drug Approvals
Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Regulatory Framework for Drug Approvals

20. Regulatory Framework for Drug Approvals (Time)
Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Regulatory Framework for Drug Approvals (Time)

21. Regulatory Framework for Drug Approvals (Fees)
Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Regulatory Framework for Drug Approvals (Fees)

22. Veterinary Medicine Reviewed
years
Number of reviewed
2013
842
2014
707
2015
684
total
2197

24. Lessons Learned from CTD Drug Dossier Submissions to SFDA
26-Jan-12
Thank You
شكرا
Tel: Ext: 5739
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