Writing Comparison of European Medicine Agency, and Saudi Food Drug Authority on Drug Regulation Systemthere is a file that has outline for the paper. I uploaded all the references that you may use.
saudi_arabia_pharmacovigilanc_gvp_.pdf
11096_2018_article_711_2.pdf
mann_s_pharmacovigilance_______part_i_the_regulatory_basis_of_pharmacovigilance_.pdf
7._pharmacovigilance_legislation_in_the_european_union_an_overview_of_legal_framework_and_developments.pdf
european_medicines_agency_pharmacovigilance_system_manual_en.pdf
Unformatted Attachment Preview
Guideline on Good
Pharmacovigilance
Practices (GVP)
Version 2.0
Date issued
27/05/2015
Date of implementation
01/09/2015
Page 1 of 499
[Guideline on Good
Pharmacovigilance Practices
(GVP)]
Version 2.0
Drug Sector
Saudi Food & Drug Authority
Please visit SFDA’s website at http://www.sfda.gov.sa for the
latest update
For Inquiries: [email protected]
For Comments or Suggestions: [email protected]
Page 2 of 499
Drug Sector
Vision and Mission
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.
الرؤية
ويقدم خدماته مبهنية ممتزية تسهم يف حامية،أن يكون قطاع ادلواء رائد ًا اقلميي ًا يف الرقابة عىل الدوية ومس تحرضات التجميل
.وتعزيز الصحة يف اململكة العربية السعودية
Mission
Protecting public health by ensuring safety, quality, efficacy and accessibility of human,
veterinary drugs and biological products, and safety of cosmetics, through administration of a
national regulatory system which is consistent with international best practice. Through our
mission, we also provide accurate and scientific-based information to the public and healthcare
professionals.
الرساةل
حامية الصحة العامة من خالل ضامن أمان وجودة وفعالية وتوفر الدوية البرشية والبيطرية واملنتجات احليوية وسالمة مواد
التجميل عرب تطبيق نظام وطين للرقابة متوافق مع أفضل املامرسات ادلولية وتقدمي املعلومات ادلوائية املبنية عىل أسس علمية
.للعامة واملهنيني الصحيني
Page 3 of 499
Document Control
Version
Date
Author
Comments
1.0
27/5/2015
Draft
2.0
1/9/2015
Vigilance and Crisis Management
Executive Directorate
Vigilance and Crisis Management
Executive Directorate
Page 4 of 499
Final
The requirements explained in this guideline is based mainly
on the European Good Pharmacovigilance Practices (GVP)
guideline
Please visit SFDA’s website at
http://www.sfda.gov.sa/en/drug/drug_reg/Regulations/GVPDefinition.pdf
for the GVP- Definition
Page 5 of 499
Table of Contents
Module I – Pharmacovigilance systems and their quality systems ……………………………………….. 24
1.A Introduction ……………………………………………………………………………………………………………. 24
I.B. Structures and processes …………………………………………………………………………………………… 25
I.B.1. Pharmacovigilance system …………………………………………………………………………………. 25
I.B.2. Quality, quality objectives, quality requirements and quality system ……………………….. 25
I.B.3. Quality cycle…………………………………………………………………………………………………….. 26
I.B.4. Overall quality objectives for pharmacovigilance ………………………………………………….. 26
I.B.5. Principles for good pharmacovigilance practices …………………………………………………… 26
I.B.6. Responsibilities for the quality system within an organization ………………………………… 27
I.B.7. Training of personnel for pharmacovigilance ……………………………………………………….. 28
I.B.8. Facilities and equipment for pharmacovigilance ……………………………………………………. 30
I.B.9. Specific quality system procedures and processes …………………………………………………. 30
I.B.9.1. Compliance management by the Marketing Authorisation Holders …………………… 30
I.B.9.2. Compliance management by the SFDA …………………………………………………………. 31
I.B.10. Record management ………………………………………………………………………………………… 32
I.B.11. Documentation of the quality system …………………………………………………………………. 33
I.B.11.1. Additional quality system documentation by marketing authorisation holders ….. 35
I.B.11.2. Critical pharmacovigilance processes and business continuity ………………………… 35
I.B.12. Monitoring of the performance and effectiveness of the pharmacovigilance system and
its quality system ……………………………………………………………………………………………………….. 37
I.B.13. Preparedness planning for pharmacovigilance in public health emergencies …………… 38
I.C. Operation of Pharmacovigilance in KSA ……………………………………………………………………. 38
Page 6 of 499
I.C.1. Overall pharmacovigilance responsibilities of the applicant and marketing authorisation
holder in KSA……………………………………………………………………………………………………………….. 38
I.C.1.1. Responsibilities of the marketing authorisation holder in relation to the qualified
person responsible for pharmacovigilance in KSA ……………………………………………………… 39
I.C.1.2. Qualifications of the qualified person responsible for pharmacovigilance in KSA ….. 42
I.C.1.3. Role of the qualified person responsible for pharmacovigilance in KSA ……………. 43
I.C.1.4. Specific quality system processes of the marketing authorisation holder in KSA … 45
I.C.1.5. Quality system requirements for pharmacovigilance tasks subcontracted by the
marketing authorisation holder …………………………………………………………………………………. 46
I.C.2. Role of the SFDA ………………………………………………………………………………………….. 47
I.C.2.1. General role of the SFDA and the role of the SFDA’s secretariat ……………………… 47
I.C.2.2. Role of the Pharmacovigilance Advisory Committee ………………………………………. 47
I.C.2.3. Specific quality system processes of the quality systems of the SFDA ………………. 48
I.C.3. Preparedness planning in KSA for pharmacovigilance in public health emergencies …. 50
Module II – Pharmacovigilance System Master File ………………………………………………………….. 51
II.A. Introduction …………………………………………………………………………………………………………… 51
IIB. Structures and processes ………………………………………………………………………………………….. 52
II.B.1. Objectives……………………………………………………………………………………………………….. 52
II.B.2. Registration and maintenance ……………………………………………………………………………. 53
II.B.2.1. Summary of the applicant’s pharmacovigilance system ………………………………….. 53
II.B.2.2. Location……………………………………………………………………………………………………. 54
II.B.2.3. Transfers of responsibilities for the pharmacovigilance system master file ……….. 54
II.B.3. The representation of pharmacovigilance systems ………………………………………………… 55
II.B.4. Information to be contained in the pharmacovigilance system master file ……………….. 57
Page 7 of 499
II.B.4.1. PSMF section on qualified person responsible for pharmacovigilance (QPPV) …. 58
II.B.4.2. PSMF section on the organisational structure of the marketing authorisation holder
…………………………………………………………………………………………………………………………….. 59
II.B.4.3. PSMF section on the sources of safety data …………………………………………………… 60
II.B.4.4. PSMF section on computerised systems and databases …………………………………… 61
II.B.4.5. PSMF section on pharmacovigilance processes ……………………………………………… 62
II.B.4.6. PSMF section on pharmacovigilance system performance ………………………………. 64
II.B.4.7. PSMF section on quality system ………………………………………………………………….. 65
II.B.4.8. Annex to the PSMF ……………………………………………………………………………………. 68
II.B.5 Change control, logbook, versions and archiving ………………………………………………….. 69
II.B.6. Pharmacovigilance system master file presentation………………………………………………. 71
II.B.6.1. Format and layout ……………………………………………………………………………………… 71
II.C. Operation within the KSA……………………………………………………………………………………….. 74
II.C.1. Responsibilities ……………………………………………………………………………………………….. 74
II.C.1.1. Marketing authorisation holders and applicants ……………………………………………… 74
II.C.2. Accessibility of the pharmacovigilance system master file ……………………………………. 75
II.C.3. Special considerations for the multinational MAHs/applicants ………………………………. 76
Annex 1 ……………………………………………………………………………………………………………………. 97
Module III – Pharmacovigilance Inspections …………………………………………………………………….. 99
III.A. Introduction …………………………………………………………………………………………………………. 99
III.B. Structures and processes ………………………………………………………………………………………. 100
III.B.1. Inspection types ……………………………………………………………………………………………. 100
III.B.1.1. System and product-related inspections……………………………………………………… 100
Page 8 of 499
III.B.1.2. Routine and “for cause” pharmacovigilance inspections ………………………………. 101
III.B.1.3. Pre-authorisation inspections ……………………………………………………………………. 103
III.B.1.4. Post-authorisation inspections ………………………………………………………………….. 104
III.B.1.5. Announced and unannounced inspections ………………………………………………….. 104
III.B.1.6. Re-inspections………………………………………………………………………………………… 105
III.B.1.7. Remote inspections …………………………………………………………………………………. 105
III.B.2. Inspection planning ……………………………………………………………………………………….. 106
III.B.3. Sites to be inspected ………………………………………………………………………………………. 108
III.B.4. Inspection scope……………………………………………………………………………………………. 108
III.B.4.1. Routine pharmacovigilance inspections ………………………………………………………… 109
III.B.4.2. For cause inspections ………………………………………………………………………………. 111
III.B.4.3. Re-inspections………………………………………………………………………………………… 112
III.B.5. Inspection process …………………………………………………………………………………………. 112
III.B.6. Inspection follow-up ……………………………………………………………………………………… 113
III.B.7. Regulatory actions and sanctions …………………………………………………………………….. 114
III.B.8. Record management and archiving………………………………………………………………….. 116
III.B.9. Qualification and training of inspectors ……………………………………………………………. 116
III.B.10. Quality management of pharmacovigilance inspection process …………………………. 117
III.C operation of pharmacovigilance inspections in the KSA ……………………………………………. 117
III.C.1. Inspection Programs ……………………………………………………………………………………… 117
III.C.2. Role of the Marketing Authorisation Holders and Applicants …………………………….. 118
Module IV – Pharmacovigilance Audits …………………………………………………………………………. 119
IV.A. Introduction ……………………………………………………………………………………………………….. 119
Page 9 of 499
IV.A.1. Terminology ………………………………………………………………………………………………… 120
IV.B. Structures and processes ………………………………………………………………………………………. 122
IV.B.1. Pharmacovigilance audit and its objective ……………………………………………………….. 122
IV.B.2. The risk-based approach to pharmacovigilance audits ……………………………………….. 122
IV.B.2.1.Strategic level audit planning ……………………………………………………………………. 123
IV.B.2.2. Tactical level audit planning…………………………………………………………………….. 125
IV.B.2.3. Operational level audit planning and reporting …………………………………………… 126
IV.B.2.4. Actions based on audit outcomes and follow-up of audits ……………………………. 128
IV.B.3. Quality system and record management practices ……………………………………………… 129
IV.B.3.1. Competence of auditors and quality management of audit activities ……………… 129
IV.B.3.2. Audits undertaken by outsourced audit service providers …………………………….. 131
IV.B.3.3. Retention of audit reports ………………………………………………………………………… 131
IV.C. Pharmacovigilance audit policy framework and organisational structure ……………………. 131
IV.C.1. Marketing authorisation holders in the KSA …………………………………………………….. 132
IV.C.1.1. Requirement to perform an audit ………………………………………………………………. 132
IV.C.2. Requirements for audit reporting in the KSA ……………………………………………………. 133
IV.C.2.1. Reporting by the marketing authorisation holder ………………………………………… 133
IV.C.3. Confidentiality ……………………………………………………………………………………………… 133
Module V – Risk management Systems ………………………………………………………………………….. 134
V.A. Introduction ………………………………………………………………………………………………………… 134
V.B. Structures and processes ……………………………………………………………………………………….. 136
V.B.1. Terminology……………………………………………………………………………………………………… 136
V.B.2. Principles of risk management …………………………………………………………………………….. 139
Page 10 of 499
V.B.3. Responsibilities for risk management within an organisation ………………………………….. 141
V.B.3.1. Marketing authorisation holders and applicants ………………………………………………. 141
V.B.3.2. SFDA ………………………………………………………………………………………………………… 143
V.B.4. Objectives of a risk management plan ………………………………………………………………….. 143
V.B.5. Structure of the risk management plan …………………………………………………………………. 144
V.B.6. Detailed description of each part of the risk management plan ………………………………… 148
V.B.7. RMP part I “Product overview” …………………………………………………………………………… 149
V.B.8. RMP part II “Safety specification” ………………………………………………………………………. 150
V.B.8.1. RMP module SI “Epidemiology of the indications and target population” ………….. 152
V.B.8.2. RMP module SII “Non-clinical part of the safety specification” ……………………….. 152
V.B.8.3. RMP module SIII “Clinical trial exposure” …………………………………………………….. 153
V.B.8.4. RMP module SIV “Populations not studied in clinical trials” ……………………………. 155
V.B.8.5. RMP module SV “Post-authorisation experience” …………………………………………… 159
V.B.8.5.1. RMP module SV section “Action taken by regulatory authorities and/or
marketing authorisation holders for safety reasons” ………………………………………………….. 159
V.B.8.5.2. RMP module SV section “Non-study post-authorisation exposure” …………….. 160
V.B.8.5.3. RMP module SV section “Post-authorisation use in populations not studied in
clinical trials” ………………………………………………………………………………………………………. 161
V.B.8.5.4. RMP module SV section “Post-authorisation off-label use” ……………………….. 162
V.B.8.5.5. RMP module SV section “Epidemiological study exposure” ………………………. 162
V.B.8.6. RMP module SVI “Additional requirements for the safety specification” ……….. 163
V.B.8.6.1. RMP module SVI section “Potential for harm from overdose” ……………………. 163
V.B.8.6.2. RMP module SVI section “Potential for transmission of infectious agents” ….. 163
V.B.8.6.3. RMP module SVI section “Potential for misuse for illegal purposes” ………….. 164
Page 11 of 499
V.B.8.6.4. RMP module SVI section “Potential for medication errors” ……………………….. 164
V.B.8.6.5. RMP module SVI section “Potential for off-label use” ………………………………. 166
V.B.8.6.6. RMP module SVI section “Specific paediatric issues”……………………………….. 167
V.B.8.7. RMP module SVII “Identified and potential risks” ………………………………………….. 168
V.B.8.7.1. RMP module SVII section “Newly identified safety concerns” …………………… 168
V.B.8.7.2. RMP module SVII section “Recent study reports with implications for safety
concerns” …………………………………………………………………………………………………………….. 169
V.B.8.7.3. RMP module SVII section “Details of important identified …
Purchase answer to see full
attachment
