Transcript Saudi Pharmaceutical Legislations

Saudi Arabia:
Veterinary Pharmaceutical
Legislations &
Marketing Authorization
Application (MAA)
Presented by:
Maher Aljaser, MHA.
Section Head, Veterinary Products Licensing
Brussels, Belgium 21-22 June
2016
Agenda
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Introduction
Saudi Food & Drug Authority (SFDA)
Veterinary Pharmaceutical
Vision and Mission
SFDA Roles and Responsibilities
Drug Approvals
Introduction
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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
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Animal Resources
Animal
type
Numbers
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
beehive
38,878 thousand
(2 milloin
ton/year)
Camel
1.4 million
Cattle
1 million
Specialized Project
SFDA Timeline
• MoH/MoA:
Responsibility-transfer
• 5/7: Framework final version
• 8/7: Guidance for submission
2009
• Operation
2003
• 10/3: Royal
Decree
2006
2008
• Sep/3:
•Vet Law
2010
2016
• Saudi Drug
Registration
system (SDR)
• 15/7:
1st draft of
Framework
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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
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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
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CEO
Shared
Services
Food
Sector
Drug
Sector
IT
Medical
Device
Sector
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Veterinary Pharmaceutical
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Drug sector (Vision and mission)
Law & Legislation
Organogram
Roles & Responsibilities
Product Registration
Website
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
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.
Legislations
Law of the General Food and Drug Authority
Law of Pharmaceutical Establishments and
preparation
Law of Veterinary Pharmaceutical for Gulf Council
Countries(GCC)
Executive Guidelines for Law of Veterinary
Pharmaceutical for Gulf Council Countries(GCC)
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Organogram
VP
Licensing
Evaluation
Pharmacovigilance
Laboratory
Inspection &
Enforcement
Cosmetics Safety
NDPIC
Licensing
Pharmacovigilance
Lab
Analysis
Inspection ,
Surveillance
&
Enforcement
Cosmetics
Safety
Core
Functions
CT, CRO
and Blood
Bank
EB
Drug
Information
Products
Evaluation‫ا‬
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Product Registration
Product Registration:
1. Guidelines
2. e-Services
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Regulatory Framework for
Drug Approvals
Regulatory Framework for Drug
Approvals (Time)
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Regulatory Framework for Drug
Approvals (Fees)
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Veterinary Medicine Reviewed
Number of reviewed
years
842
2013
707
2014
684
2015
2197
total
http://www.sfda.gov.sa
Thank You
‫شكرا‬
[email protected]
Tel: +966112038222 Ext: 5739
Fax: +966112057643
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