implementation of the new pharmacovigilance legislation
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An agency of the European Union
Implementation of the new pharmacovigilance legislation: update on status
Patients/Consumers Working Party (PCWP) and Healthcare Professionals Working Group (HCPWG) Joint Meeting European Medicines Agency, London 24 September 2012
Presented by: Franck Diafouka, Project 00305 Manager, Pharmacovigilance and Risk Management Sector
1
• Major achievements
• Next steps
• Conclusion
Content
2
Implementation journey….
PSUR
PASS
PAES Article
57
PASS
RMP
Inspections
Pharmacovigilance audits Additional
monitoring
EURD list
Black symbol
Signal detection
Referrals PRAC
Pharmaco -vigilance systems
ADR reporting
Safety announ-cements
CHMP
Web forms
Renewal
Literature monitoring
Fees
EudraVigilance
Coordination Group
EC decision
Agendas
Minutes
EMCDDA
Implementing regulation
RoP
Lists
Public hearings
EU medicines web-portal
PRAC Mandate
Fees
Drug abuse
Medication errors
Public health
EMA
Member States
Signals
Lists PRAC advice
PRAC recommen
-dation
PHARMACOVIGILANCE
Good pharmacoVigilance practice (GVP)
3
Major achievements
• Input to EC Implementing Regulation (EU) No 520/2012 published on 19/06/2012.
• 11 Good pharmacoVigilance Practice (GVP) modules drafted:
– 7 adopted (first wave)
– 2 to be adopted (comments currently being addressed)
– 2 under public consultation (until 21st September).
• Other guidance documents (under preparation e.g. Q&A/referrals procedural guidance)
• Questions and Answers (Q&As) on transitional aspects (legal and practical) published on EMA website
4
Major achievements
• Input to EC Implementing Regulation (EU) No 520/2012 published on 19/06/2012.
• 11 Good pharmacoVigilance Practice (GVP) modules drafted:
– 7 adopted (first wave)
– 2 to be adopted (comments currently being addressed)
– 2 under public consultation (until 21st September).
• Other guidance documents (under preparation e.g. Q&A/referrals procedural guidance)
• Questions and Answers (Q&As) on transitional aspects (legal and practical) published on EMA website
5
Major achievements
• Input to EC Implementing Regulation (EU) No 520/2012 published on 19/06/2012.
• 11 Good pharmacoVigilance Practice (GVP) modules drafted:
– 7 adopted (first wave)
– 2 to be adopted (comments currently being addressed)
– 2 under public consultation (until 21st September).
• Other guidance documents (under preparation e.g. Q&A/referrals procedural guidance)
• Questions and Answers (Q&As) on transitional aspects (legal and practical) published on EMA website
6
Major achievements
• Input to EC Implementing Regulation (EU) No 520/2012 published on 19/06/2012.
• 11 Good pharmacoVigilance Practice (GVP) modules drafted:
– 7 adopted (first wave)
– 2 to be adopted (comments currently being addressed)
– 2 under public consultation (until 21st September).
• Other guidance documents (under preparation e.g. Q&A/referrals procedural guidance)
• Questions and Answers (Q&As) on transitional aspects (legal and practical) published on EMA website
7
Major achievements • Plan for prioritised implementation of the pharmacovigilance legislation by the European Medicines Agency.
• Format for electronic submission of product information (‘Article 57’):
– Electronic format (made available in June 2011)
– Publication of revised legal notice and detailed guidance and provision of specific ICT tools (made available in March 2012)
– Training.
• Gap analysis
8
Major achievements • Plan for prioritised implementation of the pharmacovigilance legislation by the European Medicines Agency.
• Format for electronic submission of product information (‘Article 57’):
– Electronic format (made available in June 2011)
– Publication of revised legal notice and detailed guidance and provision of specific ICT tools (made available in March 2012)
– Training.
• Gap analysis
9
Major achievements • Plan for prioritised implementation of the pharmacovigilance legislation by the European Medicines Agency.
• Format for electronic submission of product information (‘Article 57’):
– Electronic format (made available in June 2011)
– Publication of revised legal notice and detailed guidance and provision of specific ICT tools (made available in March 2012)
– Training.
• Gap analysis
• No strategic gaps identified – only operational
• Leads and timelines assigned for gap resolution
Gap analysis
Identification and traceability of biologics
Supply to existing Patients of withdrawn
medicines
Ongoing issues in EPiTT to be closed or
mapped to new processes
EMA support for NAPs
And transitional issues
For NAPs
Outputs of PRAC and Coordination Group
Collection of data to review the impact of the legislation over
time (10 yearly review)
International liaison in The context of the new
Pharmacovigilance legislation
Templates and formats
Agenda structure for
PRAC meetings Short-term workaround ICT solutions to
support business processes
Process to collect information to publish withdrawn products
Support from Working Parties to Committees
• No strategic gaps identified – only operational
• Leads and timelines assigned for gap resolution
Gap analysis – status September 12
Identification and traceability of biologics
Supply to existing Patients of withdrawn
medicines
Ongoing issues in EPiTT to be closed or
mapped to new processes
EMA support for NAPs
And transitional issues
For NAPs
Outputs of PRAC and Coordination Group
Collection of data to review the impact of the legislation over
time (10 yearly review)
International liaison in The context of the new
Pharmacovigilance legislation
Templates and formats
Agenda structure for
PRAC meetings Short-term workaround ICT solutions to
support business processes
Process to collect information to publish withdrawn products
Support from Working Parties to Committees
12
Major achievements
• Establishment of Training Coordination Group to coordinate pharmacovigilance training within the EU network, in liaison with joint Heads of Medicines Agencies (HMA)/EMA Office of Training Steering Group (OTSG)
• Detailed Business Process Maps to support:
– future revision of ICT Project Definition Documents
– on-going development of Standard Operating Procedures (SOPs), Working Instructions (WINs) and Templates.
• EMA website will serve as the EU Medicines Web-portal
13
Major achievements
• Establishment of Training Coordination Group to coordinate pharmacovigilance training within the EU network, in liaison with joint Heads of Medicines Agencies (HMA)/EMA Office of Training Steering Group (OTSG)
• Detailed Business Process Maps to support:
– future revision of ICT Project Definition Documents
– on-going development of Standard Operating Procedures (SOPs), Working Instructions (WINs) and Templates.
• EMA website will serve as the EU Medicines Web-portal
14
Major achievements
• Establishment of Training Coordination Group to coordinate pharmacovigilance training within the EU network, in liaison with joint Heads of Medicines Agencies (HMA)/EMA Office of Training Steering Group (OTSG)
• Detailed Business Process Maps to support:
– future revision of ICT Project Definition Documents
– on-going development of Standard Operating Procedures (SOPs), Working Instructions (WINs) and Templates.
• EMA website will serve as the EU Medicines Web-portal
15
Major achievements • Upgrade of EMA corporate website (e.g. publication of safety-related referrals through the PRAC, search tool, RSS feed for agendas and minutes, …)
• Establishment of Pharmacovigilance and Risk Assessment Committee
• Enhanced cooperation with European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
• Preparation of initial lists of European Union Reference Dates (EURD) for Periodic Safety Update Reports and Products under additional monitoring
16
Major achievements • Upgrade of EMA corporate website (e.g. publication of safety-related referrals through the PRAC, search tool, RSS feed for agendas and minutes)
• Establishment of Pharmacovigilance and Risk Assessment Committee (PRAC)
• Enhanced cooperation with European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
• Preparation of initial lists of European Union Reference Dates (EURD) for Periodic Safety Update Reports and Products under additional monitoring
Establishment of PRAC
• Nomination of PRAC members (except civil society representatives appointed by the EC).
• Meeting schedule for 2012:
• Inaugural meeting 19 and 20 July.
• 3,4,5 September
• 1,2,3,4 October
• 29,30,31 October
• 26,27,28,29 November
17
Establishment of PRAC
• Principles of meeting schedule: PRAC to take place two-weeks before CHMP and Coordination Group
• To ensure high quality PRAC outputs
• To ensure robust scrutiny by CHMP and Coordination Group
• To facilitate communications
• Rules of Procedure
• Chair and Vice-Chair were elected: June Raine (United Kingdom) and Almath Spooner (Ireland)
• Principles of Rapporteur appointment and Transparency/Communication agreed 18
Establishment of PRAC
• Definition of PRAC outputs to be handled:
– with a formal decision-making phase
– without a formal decision-making phase
19
PRAC outputs with formal decision-making phase
21
PRAC outputs with formal decision-making phase
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
Activities
22
PRAC outputs with formal decision-making phase
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
PRAC AR
PRAC recommenda
-tion
European Medicines Web-portal = EMA website
Activities
23
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
PRAC AR
PRAC recommenda
-tion
European Medicines Web-portal = EMA website
Activities
24
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
PRAC AR
PRAC recommenda
-tion
Yes
European Medicines Web-portal = EMA website
Decision-making process
Activities
25
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
CHMP opinion
European Medicines Web-portal = EMA website
Decision-making process
Activities
Yes
26
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
EC decision
CHMP opinion
European Medicines Web-portal = EMA website
Decision-making process
Activities
Yes
27
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
MAH
Member States
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
EC decision
CHMP opinion
European Medicines Web-portal = EMA website
Decision-making process
Activities
Yes
28
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
Coord. Group
MAH
Member States
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
EC decision
No
CHMP opinion
European Medicines Web-portal = EMA website
Decision-making process
Activities
Yes
29
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
Coord. Group
MAH
Member States
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
EC decision
No
CHMP opinion
European Medicines Web-portal = EMA website
Decision-making process
Activities
Consen-sus?
Yes
30
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
Coord. Group
MAH
Member States
Consen-sus?
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
CG disagree-
ment
EC decision
No
CHMP opinion
CG position + timetable
European Medicines Web-portal = EMA website
Decision-making process
Activities
No
Yes
31
PRAC outputs with formal decision-making phase
One CAP at least?
Referrals Art. 107 & 31
PSUR Single
assessment
PASS results
PRAC
CHMP
CHMP in line with
PRAC?
EC
Coord. Group
MAH
Member States
Consen-sus?
PRAC AR
PRAC recommenda
-tion
CHMP disagree-
ment
CG disagree-
ment
EC decision
Yes
No
CHMP opinion
CG position + timetable
European Medicines Web-portal = EMA website
Decision-making process
Activities
No
Yes
PRAC outputs without formal decision-making phase
33
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
Annual reassessment
Coordination of safety announce
-ments
34
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
Annual reassessment
Coordination of safety announce
-ments
35
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
Annual reassessment
Coordination of safety announce
-ments
Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
36
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
Annual reassessment
Coordination of safety announce
-ments
Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
37
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
Annual reassessment
Coordination of safety announce
-ments
Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
38
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
PRAC output directly
applicable
Annual reassessment
Coordination of safety announce
-ments
Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
39
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
PRAC output directly
applicable
Annual reassessment
Coordination of safety announce
-ments
Signal detection
Activities
Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
40
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
PRAC output directly
applicable
Annual reassessment
Coordination of safety announce
-ments
Signal detection
Activities
PRAC Recommenda
-tion Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
41
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
PRAC output directly
applicable
Annual reassessment
Coordination of safety announce
-ments
Signal detection
Activities
PRAC Recommenda
-tion Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
EURD list (PSUR)
(adopted by CHMP and CG)
‘Additional monitoring’
list
Activities
42
PRAC outputs without formal decision-making phase
Risk Management
Plan
Renewal
Type II safety
variation
Activities
Pharmacovigi-lance audits
Pharmacovigi-lance
inspections
PRAC Advice
PASS Protocol
Activities
PRAC output directly
applicable
Annual reassessment
Coordination of safety announce
-ments
Signal detection
Activities
PRAC Recommenda
-tion Functionalities of EV and PSUR
repository
Activities
Black symbol for additional
monitoring
Literature monitoring
EURD list (PSUR)
(adopted by CHMP and CG)
‘Additional monitoring’
list
Activities
Lists published on EMA website
43
Major achievements • Upgrade of EMA corporate website (e.g. publication of safety-related referrals through the PRAC, search tool, RSS feed for agendas and minutes)
• Establishment of Pharmacovigilance and Risk Assessment Committee (PRAC)
• Enhanced cooperation with European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
• Preparation of initial lists of European Union Reference Dates (EURD) for Periodic Safety Update Reports and Products under additional monitoring
44
• Article 28c(2): ‘The Agency and the EMCDDA shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs’.
• Working arrangement (first signed in 2010) amended by EMA and EMCDDA Directors to strengthen information-exchange practices.
• More timely response to potential public health threats
Enhanced cooperation with EMCDDA
45
Major achievements • Upgrade of EMA corporate website (e.g. publication of safety-related referrals through the PRAC, search tool, RSS feed for agendas and minutes)
• Establishment of Pharmacovigilance and Risk Assessment Committee (PRAC)
• Enhanced cooperation with European Monitoring Centre for Drugs and Drug Addiction (EMCDDA)
• Preparation of initial lists of European Union Reference Dates (EURD) for Periodic Safety Update Reports and Products under additional monitoring
46
List of European Union Reference Dates • Adopted by PRAC in September before presentation to CHMP and Coordination Group for agreement.
• Initial list (3,364 substances) to be published on 30th September – becomes binding as of April 2013.
• List will be updated monthly (maintenance process to be finalised).
47
Major achievements
• Development of proposal for black symbol
• Five Stakeholders meetings held (3 in 2011 and 2 in 2012)
• Enriched governance structure (maintained until end 2012 – to be reviewed)
48
Major achievements
• Development of proposal for black symbol
• Five Stakeholders meetings held (3 in 2011 and 2 in 2012)
• Enriched governance structure (maintained until end 2012 – to be reviewed)
49
Major achievements
• Development of proposal for black symbol
• Five Stakeholders meetings held (3 in 2011 and 2 in 2012)
• Enriched governance structure (maintained until end 2012 – to be reviewed)
50
Project Oversight Committee (ERMS-FG)
Project Coordination
Group
12 Subproject Teams and EMA Task-Force
EMA/MSs Project Team 1
- Audits / Inspections
EMA/MSs Project Team 2
- PSURs
EMA/MSs Project Team 3
- ADR Reporting / Additional reporting / Signals
EMA/MSs Project Team 4
- RMP/PASS/ PAES/ Effectiveness of risk minimisation
EMA/MSs Project Team 5
- Committees / Referrals
EMA/MSs Project Team 6
- Communica-tion / Transparency
Enriched governance structure
51
Project Oversight Committee (ERMS-FG)
+ ICT added
Project Coordination
Group + ICT added
12 Subproject Teams and senior management EMA Task-Force
EMA/MSs Project Team 1
- Audits / Inspections
EMA/MSs Project Team 2
- PSURs
EMA/MSs Project Team 3
- ADR Reporting / Additional reporting / Signals
EMA/MSs Project Team 4
- RMP/PASS/ PAES/ Effectiveness of risk minimisation
EMA/MSs Project Team 5
- Committees / Referrals
EMA/MSs Project Team 6
- Communica-tion / Transparency
Enriched governance structure - EMA Management Board
- Heads of Medicines Agency
- ICT Directors and various groups
52
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
53
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
54
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
55
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
56
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
57
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
58
Next steps • Lessons learnt exercise and gap analysis to be finalised
• Practical aspects of public hearings to be finalised
• SOPs/WINs/Templates being finalised
• Update of fees regulation and pharmacovigilance legislation led by the European Commission
• Sixth Stakeholders forum (8th November)
• Publication of initial lists (e.g. EURD list)
• Finalise prioritised implementation for 2012
59
Conclusion • Biggest change to the EU regulatory framework since 1995
• Funding (and staffing) remains the key risk to system sustainability
• Journey is not over yet but we have a direction of travel: focus on promotion and protection of public health!
60
Conclusion • Biggest change to the EU regulatory framework since 1995
• Funding (and staffing) remains the key risk to system sustainability
• Journey is not over yet but we have a direction of travel: focus on promotion and protection of public health!
61
Conclusion • Biggest change to the EU regulatory framework since 1995
• Funding (and staffing) remains the key risk to system sustainability
• Journey is not over yet but we have a direction of travel: focus on promotion and protection of public health!
62
Thank you
PSUR
PASS
PAES Article
57
PASS
RMP
Inspections
Pharmacovigilance audits Additional
monitoring
EURD list
Black symbol
Signal detection
Referrals PRAC
Pharmaco -vigilance systems
ADR reporting
Safety announ-cements
CHMP
Web forms
Renewal
Literature monitoring
Fees
EudraVigilance
Coordination Group
EC decision
Agendas
Minutes
EMCDDA
Implementing regulation
RoP
Lists
Public hearings
EU medicines web-portal
PRAC Mandate
Fees
Drug abuse
Medication errors
Public health
EMA
Member States
Signals
Lists PRAC advice
PRAC recommen
-dation
PHARMACOVIGILANCE
Good pharmacoVigilance practice (GVP)
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