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 21-22 June 2016

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

Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 Introduction sssager@sfda.gov.sa hswohaibi@sfda.gov.sa

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 sssager@sfda.gov.sa hswohaibi@sfda.gov.sa

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

Specialized Project

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 sssager@sfda.gov.sa hswohaibi@sfda.gov.sa

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

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

Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 CEO Food Sector Drug Sector Medical Device Sector Shared Services IT hswohaibi@sfda.gov.sa hswohaibi@sfda.gov.sa

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

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

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. 

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 MAJaser@sfda.gov.sa

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

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

Product Registration Product Registration: Guidelines e-Services MAJaser@sfda.gov.sa

Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 hswohaibi@sfda.gov.sa

Regulatory Framework for Drug Approvals Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 Regulatory Framework for Drug Approvals hswohaibi@sfda.gov.sa

Regulatory Framework for Drug Approvals (Time) Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 Regulatory Framework for Drug Approvals (Time) hswohaibi@sfda.gov.sa

Regulatory Framework for Drug Approvals (Fees) Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 Regulatory Framework for Drug Approvals (Fees) hswohaibi@sfda.gov.sa

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

http://www.sfda.gov.sa

Lessons Learned from CTD Drug Dossier Submissions to SFDA 26-Jan-12 Thank You شكرا majaser@sfda.gov.sa Tel: +966112038222 Ext: 5739 Fax: +966112057643 MAJaser@sfda.gov.sa hswohaibi@sfda.gov.sa