Implementation of the New
Pharmacovigilance Legislation
HMPWG meeting
Warsaw, 7-8 December 2011
Presented by: Tomasz Jabłoński
Legal Administrator, Legal Service - Directorate
An agency of the European Union
In this presentation
•
•
•
•
New pharmacovigilance
New pharmacovigilance
New pharmacovigilance
New pharmacovigilance
deliver?
• Conclusions
2
legislation:
legislation:
legislation:
legislation:
Implementation of the New Pharmacovigilance Legislation
Why?
How?
What?
What to
Why: to further strengthen
pharmacovigilance (1/2)
EC impact assessment:
• 5% of all hospital admissions are for ADRs, 5% of all
hospital patients suffer an ADR, 5th most common cause of
hospital death
• Estimated 197,000 deaths per year in EU from ADRs
• Societal cost of Euro 79 Billion
• Cost savings to society from the legislation in range Euro
237 Million – 2.4 Billion
• Health savings between 591 and 5910 lives saved per year
3
Implementation of the New Pharmacovigilance Legislation
Why: to further strengthen
pharmacovigilance (2/2)
• Annual industry spending on PhV Euro 833 Million
• Annual industry savings from the proposals Euro 145 Million
(17.4%)
• Cost to EMA:
• Euro 3.9 million set up cost
• Euro 10.1 million annual running costs (covered by new
fees)
• Significant changes to the EMA tasks during the co-decision
procedure.
4
Implementation of the New Pharmacovigilance Legislation
Why: high level objectives
The new regulation and directive on
pharmacovigilance constitute the biggest change
in legal framework for the EMA since its
establishment in 1995.
The provisions impact far beyond a narrow definition
of pharmacovigilance and risk management.
5
Implementation of the New Pharmacovigilance Legislation
Why: high level objectives (1/2)
Promote and protect public health by reducing
burden of ADRs and optimising the use of
medicines:
•
•
•
•
•
Clear roles and responsibilities
Risk based/proportionate
Increased proactivity/planning
Reduced duplication/redundancy
Integrate benefit and risk
6
Implementation of the New Pharmacovigilance Legislation
Why: high level objectives (2/2)
Promote and protect public health by reducing
burden of ADRs and optimising the use of
medicines (cont’d):
•
•
•
•
•
Ensure robust and rapid EU decision-making
Strengthen the EU Network
Engage patients and healthcare professionals
Increase transparency and accountability
Provide better information on medicines
7
Implementation of the New Pharmacovigilance Legislation
How: making of new legislation by the
European Commission (1/3)
• 2003: EC decision to undertake an assessment of the Community
system of pharmacovigilance
• 2005: Independent study completed to map the strengths and
weaknesses of the EU system
• 2006-2008: Research, consultation, policy development
• December 2008: “Pharma package” (PhV, information to patients and
falsified medicines) adopted by the European Commission and
transmitted to Council and European Parliament for co decision
procedure to start
8
Implementation of the New Pharmacovigilance Legislation
How: making of new legislation by the
European Commission (2/3)
• Co-decision work starts on revisions to Directive 2001/83/EC
and revisions to Regulation (EC)2004/726
• 23 June 2010: Agreement on final text (first reading
agreement)
• 22 September 2010: Final favourable vote in the European
Parliament
9
Implementation of the New Pharmacovigilance Legislation
How: making of new legislation by the
European Commission (3/3)
Publication in OJ L 348
•Regulation (EU) No 1235/2010 of the European Parliament and of the Council of
15 December 2010 amending, as regards pharmacovigilance of medicinal products
for human use, Regulation (EC) No 726/2004 laying down Community procedures
for the authorisation and supervision of medicinal products for human and
veterinary use and establishing a European Medicines Agency, and Regulation
(EC) No 1394/2007 on advanced therapy medicinal products (applicable from 2
July 2012)
•Directive 2010/84/EU of the European Parliament and of the Council of 15
December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC
on the Community code relating to medicinal products for human use (applicable
from 21 July 2012)
10
Implementation of the New Pharmacovigilance Legislation
How: further amendments envisaged
‘(…) in view of recent pharmacovigilance events in the EU, the
Commission has detected certain areas where the legislation could be
further strengthened’
•
Amended EC proposal for a Regulation amending Regulation (EC)
726/2004 as regards information to the general public on medicinal
products subject to medical prescription and as regards
pharmacovigilance
•
Amended EC proposal for a Directive amending Directive 2001/83/EC, as
regards information to the general public on medicinal products subject
to medical prescription and as regards pharmacovigilance
11
Implementation of the New Pharmacovigilance Legislation
Impact on homeopathic medicinal
products
• Article 16(3) Dir. 2001/83/EC:
‘Title IX [Pharmacovigilance] shall apply to
homeopatic medicinal products, with the
exception of those referred to in Article 14(1)’
• References to HMP registered according to the
simplified procedure (Article 14 Dir. 2001/83/EC) in
the amended Regulation (EC) 726/2004
12
Implementation of the New Pharmacovigilance Legislation
What: key changes for ADRs (1/2)
Better ADR Reporting
- New ADR definition:
‘A response to a medicinal product which is noxious and
unintended’
-So far:
‘A response to a medicinal product which is noxious and unintended and
which occurs at doses normally used in man for the prophylaxis,
diagnosis or therapy of disease or for the restoriation, correction or
modification of physiological function
13
Implementation of the New Pharmacovigilance Legislation
What: key changes for ADRs (2/2)
-Medication errors that result in an ADR are reported
-Patient reporting – the debate on ‘if’ is over! Now debate ‘how’!
-After transitional period:
-All ADRs from companies and from Member States are sent to Eudravigilance
only (MSs only get their national reports and industry accesses reports via
EudraVigilance) with major increases in data volumes - from 40,000 now to
100,000 case reports per month anticipated,
-Member States are ‘auto-forwarded’ their national data
-Companies access reports in Eudravigilance
14
Implementation of the New Pharmacovigilance Legislation
What: PRAC and decision-making (1/5)
PRAC and Decision-making:
• New Pharmacovigilance Risk Assessment Committee
– Mandate: all aspects of the risk management of the use of
medicinal products including the detection, assessment,
minimisation and communication relating to the risk of
adverse reactions, having due regard to the therapeutic
effect of the medicinal product, the design and evaluation of
post-authorisation safety studies and pharmacovigilance
audit
15
Implementation of the New Pharmacovigilance Legislation
What: PRAC and decision-making (2/5)
•
PRAC and Decision-making:
–
Composition:
–
Members/alternates appointed by each MS
–
6 members appointed by Commission
–
1 member/alternate representing health care professionals
–
1 member/alternate representing patients associations
with a view to ensuring that the relevant expertise is available within the
Committee, including clinical pharmacology and pharmacoepidemiology,
on the basis of a public call for expressions of interest
16
–
Possible delegation from only one MS to another (max 1)
–
Collaboration with CHMP rapporteur or the reference MS
Implementation of the New Pharmacovigilance Legislation
What: PRAC and decision-making (3/5)
•
PRAC and Decision-making:
- Role:
–
Interaction with CHMP/coordination group recommendations
forwarded to
– CHMP for opinion
– Coordination group for agreement
–
Justification if not in accordance with recommendations
–
PRAC recommendations publicly available with
opinion/agreement
–
17
Agreement and monitoring RMPs
Implementation of the New Pharmacovigilance Legislation
What: PRAC and decision-making (4/5)
“No CAP
concerned”
Single AR prepared by the Member State
appointed by the CMD
PRAC to adopt the AR
If any regulatory action results from the AR, CMD
to reach a position: maintenance, variation,
suspension or revocation + according timetable
for implementation
MS =
CMD ≠ PRAC
Decision sent the MAHs and MSs
concerned
18
MS
≠
Detailed explanations to be annexed.
CMD has the legal power
Position of the majority of MSs to be
sent to the Commission which will
Implementation of the New Pharmacovigilance
Legislation
adopt
a decision
What: PRAC and decision-making (5/5)
“At least 1 CAP
concerned”
Single AR prepared by the Rapporteur
appointed by the PRAC
PRAC to adopt the AR
If any regulatory action results from the AR,
CHMP to adopt an opinion: maintenance,
variation, suspension or revocation + according
timetable for implementation
Commission to adopt a decision
concerning the regulatory action(s)
19
Implementation of the New Pharmacovigilance Legislation
What: referrals (1/2)
-
New ‘urgent Union procedure’ replaces current Article 107 and can
include CAPs
-
Article 36 deleted
-
2 procedures for pharmacovigilance data, depending on urgency:
-
20
–
Article 107i urgent procedure
–
Article 31 all other cases
All pharmacovigilance referrals go to PRAC – PRAC to issue
recommendation
Implementation of the New Pharmacovigilance Legislation
What: referrals (2/2)
-
EMA can enlarge scope of referrals
-
‘May’ clause re. public hearing (with EMA guidance on when and
how),
-
Member States retain discretion of when to refer (the original
Commission concept of automatic referrals is lost)
-
To be applied to all products (including centralised)
-
New role for the Coordination Group on the decision making
process
-
Article 20 for pharmacovigilance data also goes to PRAC
21
Implementation of the New Pharmacovigilance Legislation
What: Risk Management planning (1/2)
Risk Management planning:
• New definition of a ‘risk management system’ : ‘a set of
pharmacovigilance activities and interventions, such as studies and
reports, designed to identify, characterise, prevent or minimise risks
relating to a medicinal product, including the assessment of the
effectiveness of those activities and interventions’
• New definition of a ‘Risk management plan’: ‘ a detailed
description of the risk management system’
• Requirement for all new products but risk proportionate
22
Implementation of the New Pharmacovigilance Legislation
What: Risk Management planning (2/2)
• Legal basis to require a risk management system/ plan for an
authorised product. (‘if there are concerns about the risks
affecting the risk-benefit balance’)
• Safety and efficacy studies included (move towards integrated
B/R)
• Systematic role for the new Committee (PRAC)
23
Implementation of the New Pharmacovigilance Legislation
What: Periodic safety update reports
(PSURs) (1/3)
Content:
•
Summaries of data relevant to the BR of the medicinal product, incl.
results of all studies with a consideration of their potential impact on the
marketing authorisation
•
A scientific evaluation of the R-B balance of the medicinal product
•
All data relating to the volume of sales of the medicinal product and any
data in possession of the MAH relating to the volume of prescriptions,
incl. an estimate of the population exposed to the medicinal product
24
Implementation of the New Pharmacovigilance Legislation
What: Periodic safety update reports
(PSURs) (2/3)
• Submitted electronically to EMA (where Member States access)
• Some products categories (e.g. generics, homeopathic medicinal
products registered according to the simplified procedure,
traditional herbal medicinal products) exempted from ‘regular’
submissions. PSURs required only:
- where such obligation has been laid down as a condition in the MA
- when requested by a competent authority on the basis of concerns
relating to PhV data or due to the lack of PSURs relating to an active
substance after MA has been granted
25
Implementation of the New Pharmacovigilance Legislation
What: Periodic safety update reports
(PSURs) (3/3)
• For established substances, single EU assessment for all
products
• Assessment leads to automatic regulatory action: variations,
suspension, revocation
• Periodicity will be established by EMA (binding list on website)
• Likely to replace many referrals
26
Implementation of the New Pharmacovigilance Legislation
What: PASS/PAES (1/2)
Strengthened legal basis to require post-authorisation studies:
- post-authorisation safety study (PASS)
- post-authorisation efficacy study (PAES)
• Regulators can require study by industry at first authorisation
• Regulators can require study by industry post-authorisation
27
Implementation of the New Pharmacovigilance Legislation
What: PASS/PAES (2/2)
• Study is a condition of the authorisation and is legally binding
• In the event that the same safety concern applies to more
than one medicinal product, the EMA / national competent
authority shall …… encourage the marketing authorisation
holders concerned to conduct a joint post-authorisation
safety study
28
Implementation of the New Pharmacovigilance Legislation
What: medicinal products subject to
additional monitoring
– New active substances
– New MA biological products (including biosimilars)
– Any other upon request (+PRAC) for products
specific requirements in the RMP
– Symbol and statement and standardised
explanatory sentence in SmPC and leaflet
– Deletion from the list after 5 years or conditions
met
29
Implementation of the New Pharmacovigilance Legislation
What: signal detection (1/2)
• For first time the concept is recognised
• Clear roles and responsibilities for EMA and Member States; EMA will
lead the signal detection for CAPs and support and coordinate signal
detection by the MSs for NAPs
• Minimum standards for signal detection will be the subject of a
legally binding Commission regulation and of independent audit
• ‘Monitor the data in the EudraVigilance database to determine
whether there are new risks or whether risks have changed and
whether those risks impact on the risk benefit balance’
• PRAC performs initial analysis and prioritisation of signals of new
risks or risks that are changing or changes to the R-B balance
30
Implementation of the New Pharmacovigilance Legislation
What: signal detection (2/2)
• Increased ADR volumes need to be analysed
• Signal detection linked to patient reporting will be required
• Signal detection linked to PSURs will be required
• For NAPs there is a need to develop new procedures and
analyses
31
Implementation of the New Pharmacovigilance Legislation
What: EU medicinal product dictionary
• ‘The Agency shall establish a list of all medicinal products
authorised in the Community. To this effect the following
measures shall be taken:
– (a) the Agency shall…..make public a format for the
electronic submission of medicinal product information
– (b) MAHs shall, by (18 months after the entry into force of
regulation), electronically submit to the Agency information for all
medicinal products authorised or registered in the
Community, using the format referred to in point (a);
– (c) from the date set out in point (b), MAHs shall inform the
Agency of any new or varied authorisations (…)
32
Implementation of the New Pharmacovigilance Legislation
What: transparency and communication
• EU and national medicines web-portals linked together
• MSs to add their product information to their national web-portals
• Dramatic increase in transparency (all assessment conclusions public)
• EMA to coordinate MSs safety announcements on NAPs (as well as
CAPs)
• Public hearings
• Overall the communication/networking/transparency provisions will
require significant IT (for web-portal) and staff resources
33
Implementation of the New Pharmacovigilance Legislation
What: key changes keeping product info
up to date
-MAH shall inform of any prohibitions or restrictions or any new
information which may influence the evaluation of benefits and
risks….’include both positive and negative results of clinical trials or other
studies in all indications and populations, whether or not included in the
marketing authorisation, as well as data on use of the medicinal product
where such use is outside the terms of the marketing authorisation’.
-MAH shall keep their product information up to date with current
scientific knowledge, including the conclusions of the assessments and
recommendations on the EU medicines web-portals
-Regulators may at any time ask the MAH to forward data demonstrating
that the BR balance remains favourable. MAH shall answer fully and
promptly any such request.
34
Implementation of the New Pharmacovigilance Legislation
Funding pharmacovigilance activities
• EMA to collect fees for pharmacovigilance activities for
services provided by the EMA or Coordination Group
• Rapporteurs to be paid by the EMA
• Fees for pharmacovigilance, literature monitoring,
information technology tools, provision of information to the
public
• Payment rapporteurs providing assessment for Union
pharmacovigilance procedures, PSURs, PASSs protocols and
risk management systems
35
Implementation of the New Pharmacovigilance Legislation
Further changes – EC proposals
• Article 23 Reg. (list of medicinal products subject to additional
monitoring
• Article 20 Reg. (clarification of respective scopes of this provision)
• Article 107i Dir. (automatic procedure at EU level in the cases of
specific serious safety issues with NAPs)
• Article 13 and Article 14b Reg. / Article 23a and 123 Dir. (in order to
avoid that voluntary withdrawal of a MA could lead to safety issues
not being addressed in the EU)
36
Implementation of the New Pharmacovigilance Legislation
Implementing measures (1/2)
Reg. (EC) 726/2004 Art. 87a
Dir. 2001/83/EC Art. 108
After public consultations (deadline: 7 November 2011)
•
The content and maintenance of the pharmacovigilance
system master file kept by the MAH
•
The minimum requirements for the quality system for the
performance of pharmacovigilance activities by the Agency
(the NCAs and MAH)
•
The use of internationally agreed terminology, formats and
standards for the performance of pharmacovigilance activities
37
Implementation of the New Pharmacovigilance Legislation
Implementing measures (2/2)
Reg. (EC) 726/2004 Art. 87a
Dir. 2001/83/EC Art. 108
•
The minimum requirements for the monitoring of data
included in the EV database to determine whether there are
new risks or whether risks have changed
•
The format and content of electronic transmission of
suspected adverse reactions by MSs and MAHs
•
The format and content of electronic PSURs and RMPs
•
The format of protocols, abstracts and final study reports of
the PASS
38
Implementation of the New Pharmacovigilance Legislation
Clarification of roles (1/3)
• EMA
– Scientific and coordinating role reinforced
– New scientific committee Pharmacovigilance Risk Assessment
Advisory Committee (PRAC) with important role ‘For the
fulfilment of its pharmacovigilance tasks including
agreement and monitoring of risk management systems,
it (CHMP) shall rely on scientific assessment and
recommendations of the PRAC’
– Key role for EMA and PRAC in signal detection and follow up
– Remuneration by EMA contract with rapporteurs for
PSURs, Union procedures
39
Implementation of the New Pharmacovigilance Legislation
Clarification of roles (2/3)
• Member States
– Conducting pharmacovigilance for products on their market, signal
detection and follow up
– Operation of the pharmacovigilance system
– Increased cooperation and worksharing
– Improvement coordination group (alternates, EMA support,
remuneration, decision making process)
– Penalties for non-compliance
+ other obligations (Article 102 Dir. 2010/84/EU)
40
Implementation of the New Pharmacovigilance Legislation
Clarification of roles (3/3)
• MAHs
– Operation pharmacovigilance system
– Summary to authorities
– Detailed updated pharmacovigilance system master file
on site (inspection)
– Risk management system (proportionate to risks) in all MA
– Continuous monitoring of safety information and update MA
41
Implementation of the New Pharmacovigilance Legislation
What to deliver:
governance structure for EMA tasks (1/6)
• Need to cope with the
– Complexity of the network
– Number of (scientific) fora directly affected by the new
legislation and providing input into the preparation for the
implementation
• Need for
– Consensus – building within the network
– Interaction with stakeholders
42
Implementation of the New Pharmacovigilance Legislation
What to deliver:
governance structure for EMA tasks (2/2)
Project
Oversight
Committee
(ERMS-FG)
Project
Coordination
Group
6 EMA/MSs Project Teams
EMA/MSs
Project
Team 1
- Audit/
Inspections
EMA/MSs
Project
Team 2
PSURs
EMA/MSs
EMA/MSs
Project
Project
Team 3
Team 4
ADR reporting
-RMP/
/Additional
PASS/PAES
Monitoring/ -Effectiveness
-Signals
of risk
Minimisation
12 EMA Subproject Teams
PSUR
Product Info. Committees
EMA TaskImplementation of the New Pharmacovigilance Legislation
43Force
PASS/PAES
EV/ADR rep.
Referrals
EMA/MSs
Project
Team 5
-Committees/
Referrals
EMA/MSs
Project
Team 6
-Communication/
Transparency
Fees
Lit. monit/
Signal detect.
RMS
Com./Transp
Insp./PhV sy.
PhV audits
What to deliver: working methodology
Project
Oversight
ERMS FG
Project
Coordination
Group
Project
Teams
Subproject
Teams
44
Actions
Table
Status
Report
Concept
Paper
Impl.
Meas.
Status
Report
Concept
Paper
Impl.
Meas.
Adopted
Concept
Paper
Impl.
Meas.
Drafted/
Agreed
Tracking Concept
Table
Paper
Impl.
Meas.
Issue
Log
Tracking
Table
Actions
Table
Status
Report
Issue
Log
Implementation of the New Pharmacovigilance Legislation
Adopted
Drafted
What to deliver: reporting timelines
Friday
2 weeks before CHMP
Subproject Teams
submit Status Report
Project Coord. Group
submits Status Report
to ERMS FG
Wednesday
Week after CHMP
45
Friday
Week before CHMP
Project Teams
submit Status Report
Project Coord. Group
meets to review Status
Reports
Wednesday
Implementation of the New Pharmacovigilance Legislation
CHMP week
What to deliver: implementation
phasing plan
July 2012
Q1 – Q2 2011
Phase I
Q3 2011 – Q3 2012
Phase II
-Technical
contribution to EC
draft implementing
measures
- Format of product
Information (Reg.
Art.57)
-Key papers
-Good Vigilance Practice and other guidelines
-First round of
Business Process
Mapping
-IT requirements
-Second and third rounds of Business Process
Modelling
-Standard Operating Procedures, Working
Instructions, Templates
-RoP, Mandate
-ICT tools development
46
Implementation of the New Pharmacovigilance Legislation
-Documentation
update
-Documentation
update
-ICT tools
maintenance
What to deliver: prioritisation
•
EMA/MSs technical contribution to EC Implementing measures
(priority)
• Business process mapping
• IT requirements supported by business process mapping
• Concept papers (for policy issues)
• Good Vigilance Practice guidelines
• SOPs/WINs/Templates
47
Implementation of the New Pharmacovigilance Legislation
What to deliver:
Hierarchy of rules
Deliverables
- Regulation (EU) 1235/2010
- Directive 2010/84/EU
EC Implementing
Measures
= Commission Regulation
(Reg. Art. 87a and Dir.Art.108
EMA/MSs
Technical contribution
Concept Papers
- Policies
- Operations
- ICT
48
Process Mapping
IT requirements
Implementation of the New Pharmacovigilance Legislation
Guidelines
SOP/WIN/Templates
IT tools
What to deliver: interaction with
stakeholders
• Stakeholders meetings involving EMA, Member States, EC,
industry, patients and healthcare professionals representatives
• Positive feedback from 3 stakeholders meeting held at EMA’s
permisses
• Scheduling of additional Stakeholders forum will be based on
content development
49
Implementation of the New Pharmacovigilance Legislation
2011
Jan
Feb
Mar
Apr
May
Jun
3 10 17 24 31 7 14 21 28 7 14 21 28 4 11 18 25 2 9 16 23 30 6 13 20
Jul
Aug
Sep
Oct
Nov
Dec
27 4 11 18 25 1 8 15 22 29 5 12 19 26 3 10 17 24 31 7 14 21 28 5 12 19 26
Meetings
♦
1. EMA Task-Force meetings
2. Project Teams' meetings
3. ERMS FG meetings
4. Stakeholders' meetings
5. Management Board meetings
6. HMA meetings
Topics
1. Periodic Safety Update Reports
2. PASS/PAES
3. Product Information
4. EudraVigilance/Adverse Drug Reactions reporting
5. Committees
6. Referrals
7. Fees*
8. Communication/Transparency
9. Literature Monitoring/Signal Detection
10. Inspections/Pharmacovigilance Systems
11. Risk Management Systems
12. Pharmacovigilance Audits
50
♦
♦
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♦
♦
♦
♦
♦
♦
♦
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♦
♦
Draft content
Design business processes
8.1 Business processes
8.2 Define common strategy
8.3 SOP/WIN/Template/Guideline
8.4 IT requirements
Design business processes
Draft Concept Paper
9.1 Implementing measures (Reg. Art. 87a(d))
9.2 Business processes
9.3 SOP/WIN/Template/Guideline
9.4 Plan for outsourcing of literature
monitoring*
10.1 Implementing measures (Reg. Art. 87a(a-b))
10.2 Business processes
10.3 SOP/WIN/Template/Guideline
10.4 IT requirements
11.1 Implementing measures (Reg. Art. 87a(f))
11.2 Business processes
11.3 SOP/WIN/Template/Guideline
11.4 IT requirements
12.1 Business processes
12.2 Define common strategy
12.3 SOP/WIN/Template/Guideline
12.4 IT requirements
13.1 Consolidate IT requirements
Draft content
Design business processes
Peer-review Finalisation
♦
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Draft content
Design business processes
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Draft content
Design business processes
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Draft content
Design business processes
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Design business processes
Preparation of rules of procedure/mandate
Nomination process
Preparation of SOP/WIN/Template/Guidelines
Consultation Adoption
Define IT requirements
Design business processes
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Consultation
Finalisation Adopt (ERMS)
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Draft content
Design business processes
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Draft content
Design business processes
Peer-review Finalisation
Adopt (ERMS) EC Consultation and Adoption
Preparation of SOP/WIN/Template/Guidelines
Define IT requirements
Design business processes
Draft Concept Paper Consultation
Finalisation
Define IT requirements
Consolidation
Adopt (ERMS)
Preparation of SOP/WIN/Template/Guidelines
♦
♦
♦
♦
Activity
1.1 Implementing measures (Reg. Art. 87a(f))
1.2 Business processes
1.3 SOP/WIN/Template/Guideline
1.4 IT requirements
1.5 Plan audit on PSUR repository*
2.1 Implementing measures (Reg. Art. 87a(g))
2.2 Business processes
2.3 SOP/WIN/Template/Guideline
2.4 IT requirements
3.1 Implementing measures (Reg. Art. 87a(c))
3.2 Business processes
3.3 SOP/WIN/Template/Guideline
3.4 IT requirements
4.1 Implementing measures (Reg. Art. 87a(e))
4.2 Business processes
4.3 SOP/WIN/Template/Guideline
4.4 IT requirements
4.5 Plan audit on EV*
5.1 Business processes
5.2 Rules of procedure/Mandate
5.3 Committee membership
5.3 SOP/WIN/Template/Guideline
5.4 IT requirements
6.1 Business processes
6.2 SOP/WIN/Template/Guideline
6.3 IT requirements
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Implementation of the
New Pharmacovigilance Legislation
13.2 Plan for IT development*
13. Information Technology tools
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Conclusions: EMA is the hub of the
European network
New legislation:
• opportunity to strengthen and
rationalise public health
• Major work to ensure full and
effective implementation
• Resources are needed
• Collaboration will be key
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Implementation of the New Pharmacovigilance Legislation
THANK YOU! Any questions?
The views expressed in this presentation are those of the author and do not necessarily reflect and cannot be quoted as the views of the
European Medicines Agency
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Implementation of the New Pharmacovigilance Legislation