Saudi FDA Drug Approval Process. Dr. Mohammed A. Alquwaizani Consultant- Chief of the scientific office Saudi Food and Drug Authority

Transcription

1 Saudi FDA Drug Approval Process Dr. Mohammed A. Alquwaizani Consultant- Chief of the scientific office Saudi Food and Drug Authority

2 Objective Describe the drug regulation practice in Saudi Arabia and the workflow at the National Pharmacovigilance Center

3 Drug Registration at the SFDA Drug Approval Pre-registration Phase Post-marketing phase

4 Drug Application 2 Drug Samples 1 Application Form 3 Product File Drug Application 4 MAJaser@sfda.gov.sa

5 Types of application Marketing Authorization Application of Medicinal Product for Human Use: New Drug o Known active substance o New Chemical Entity (NCE) Generic (Multisource) Biological o Biosimilar o Blood product o Vaccine o Others (please specify): Radiopharmaceutical

6 CTD Format Module 1 Regional Administrative Information Not Part of CTD Module 2 Quality Overall Summary Nonclinical Overview Nonclinical Summaries Clinical Overview Clinical Summary CTD Module 3 Quality Module 4 Nonclinical Study Reports Module 5 Clinical Study Reports 6 MAJaser@sfda.gov.sa

7 DrugApproval Process Dossier Submission Scientific Assessment Decision 245 Days Validation Testing 90 Days Pricing Product Licensing 10 Days Pricing 60 Days 30 Days 60 Days Inspection Days MAJaser@sfda.gov.sa

8 Post- Registration Phase Post- marketing surveillance Pharmacovogilance and drug safety monitoring activity Quality continuous monitoring

9 National Pharmacovigilance and Drug Safety Center (NPC) Mission: To contribute in protection of public health through monitoring of the safety and quality of medicines and to ensure healthcare professionals and patients have access to up to date safety information about medicines

10 Pharmacovigilance (PV) The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problems * * World Health Organization (WHO) definition 10

11 NPC Objectives Improve patient safety in relation to the use of medicines Detection of ADRs at an early stage Detection of increase in frequency of known ADRs Prevention of adverse drug events, if possible Promotion of understanding, education and training in Pharmacovigilance Encouraging rational and more effective use of medicines Liaison with international centers

12 Work Teams of The NPC 1. Data capture and entry team 2. Signal detection team 3. Risk minimization team 4. Periodic safety update report (PSUR) evaluation team

13 Source of ADRs Reports 1 Public 2 Health Care providers 3 Marketing Authorization Holders

14 Work Teams of The NPC 1. Data capture and entry team 2. Signal detection team 3. Risk minimization team 4. Periodic safety update report (PSUR) team

15 Data Entry And Capture Team Data Entry MedDRA Coding Clinical Evaluation 1ry Evaluation The NPC s Database

16 Work Teams of The NPC 1. Data capture and entry team 2. Signal detection team 3. Risk minimization team 4. Periodic safety update report (PSUR) team

17 Signal Detection Team DRUG ADR Signal Evaluation Valid Signal In-valid Signal The NPC s Database Risk Minimization Team

18 Work Teams of The NPC 1. Data capture and entry team 2. Signal detection team 3. Risk minimization team 4. Periodic safety update report (PSUR) team

19 Never addressed in KSA Risk Minimization Team New valid Signal New Published Alert Alert from other Regulatory bodies Safety Review Safety Recommendations

20 Work Teams of The NPC 1. Data capture and entry team 2. Signal detection team 3. Risk minimization team 4. Periodic safety update report (PSUR) team

21 PSUR Team PSUR is one of the regulatory requirement that allows a periodic but comprehensive assessment of the worldwide safety data of authorized drugs.

22 PSUR components Overall safety evaluation Introduction Marketing authorizatio n status Other information PSUR SECTIONS Regulatory authority changes due to safety information Safety Recommendations Studies Changes to reference safety information Individual Cases analysis Patient exposure

23 Safety Recommendations Safety Recommendations from safety reviews and PSURs evaluations could be: Positive Impact Safety Communications Adding Precautions Updating the Risk Minimization Plan of the drug Drug suspension Drug withdrawal on Public Health

24 THANK YOU