The impact of the new
EU Pharmaceutical Legislation on the
European Medicines Agency’s Activities
Vincenzo Salvatore
Head of Legal Service
Budapest, 13 May 2011
The views expressed in this presentation are those of the author only.
They do not necessarily reflect and cannot be quoted as the views of the European Medicines Agency
An agency of the European Union
What is it all about
•
A strengthened EU system for monitoring of
medicinal products
•
New tools to reduce the likelihood of falsified
products in the legal supply chain
•
A modified proposal on non promotional information
on medicinal products to be provided to patients
•
How the European Medicines Agency is affected by
the new legislation and how it is preparing for its
implementation
2
Status
•
Pharmacovigilance:  Regulation (EU) No 1235/2010
 Directive 2010/84/EU
•
Falsified medicines:  Approved by the EP on 16/2/2011
•
Information to patients:  Modified proposal awaited
3
Pharma package objectives
•
To better protect patients by strengthening
the EU pharmacovigilance system
•
To enable citizens to get high-quality
information on medicines
•
To tackle the growing issues of
counterfeiting and illegal distribution of
medicine
4
Avoid overlapping
I will focus on:
- PhV legislation only
- Impact on the Agency’s
activities
I will not address:
- Details of the new legislation
5
PhV Key issues
Enhance high levels of public health protection
while exploiting the potential for:
6
•
Proportionality in the safety requirements
•
Simplification
•
Increased efficiency in the network
The PhV Galaxy
Audit / Fees /
Small markets
Change
Authorisation
Requirements
Risk
Management
Plan
Legal basis
PASS /
Efficacy Studies
Co-ordination
inspections
PhV
Transparency
Communication
Risk
minimisation
MPs subject
to additional
monitoring
Committees
and DMP
PSUR
Worksharing
7
ADRs
Signal
detection
Scope of changes…everything in one slide!
- Authorisation requirements change (PSMF, key risk management measures in MA)
- Risk Management Plan, risk proportionate and for all new products (+justified old)
- Legal basis for PASS + legal basis for efficacy studies (PAES)
- Effectiveness of risk minimisation
- Product information change – ‘additional monitoring’ + encourages ADR reporting
- ADR reporting simplified + patient reporting + medication errors + role of EV + literature
monitoring + reporting to WHO
- Signal detection has clear roles and responsibilities
- PSUR submission simplified (electronic) and single assessment + benefit: risk
- New PRAC Committee and its interaction with CMD(h)/CHMP) in decision-making process
- Transparency and communication (webportals, EV access, coordinate MSs, hearings)
- Enhanced coordination of inspections
- Regular EMA and MS + MAH audit
- Fees for pharmacovigilance
8-
Access in small markets – labelling exemption etc.
Impact on the EMA
•
Strengthened coordinating role in the Pharmacovigilance system
•
Creation of a new Committee: the Pharmacovigilance Risk Assessment
Advisory Committee (PRAC)
•
Creation of European medicines webportal
•
Eudravigilance database as single point of receipt of pharmacovigilance
information: accessible to MSs, EMA and Commission and partially also to
MAHs and the public
•
Signal detection of new/changed risks in Eudravigilance + literature
monitoring
•
Together with MS monitor the outcome of risk minimisation measures
9
Pharmacovigilance Risk Assessment Committee (PRAC)
Mandate: All aspects of the risk management of the use of medicines
•
•
•
•
Chairman & Vice-Chairman
1 scientific expert member nominated by each MS and 1 alternate
6 members appointed by European Commission
1 member representing Health Care professionals + 1 alternate
(appointed by EC)
• 1 member representing Patients Associations + 1 alternate
(appointed by EC)
• Possibility of delegation of activities by MS in another MS
(max 1 representation by MS)
6
10
Decision-making for PSURs, referrals, PASS
Single AR prepared by the Member State appointed by CMD(h)
“No CAP
concerned”
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 =
MS
≠
Decision sent the MAHs and MSs
concerned
11
CMD(h) ≠ PRAC
Detailed explanations to be annexed.
CMD has the legal power
Position of the majority of MSs
to be sent to the Commission
which will adopt a decision
Decision-making for PSURs, referrals, PASS
“At least 1 CAP
concerned”
Single AR prepared by the Rapporteur appointed by 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)
12
EMA Priorities
• EMA/MSs technical contribution to EC Implementing
measures
• Business process mapping
• IT requirements supported by business process
mapping
• Concept papers (for policy issues)
• Good Vigilance Practice guidelines
• SOPs/WINs/Templates
13
Hierarchy of rules
- Regulation (EU) 1235/2010
- Directive 2010/84/EU
- EC Implementing measures
= Commission Regulation
(Reg. Art. 87a and Dir. Art. 108)
- Policies
- Operations
- ICT
14
Guidelines
SOP/WIN/Templates
IT Tools
Impact on
EMA and
MSs
Some Key Changes
Transparency and Communication:
• EU and National Medicines web-portals
• Dramatic increase in transparency e.g. ‘protocols
and public abstracts of results as regards post
authorisation safety studies’
• EMA to coordinate MS safety announcements
• Public hearings
15
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:
–
–
–
16
(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 (…)
Governance – EU Network
Project
Oversight
Committee
(ERMS-FG)
Project
Coordination
Group
6 EMA/MSs Subproject Teams
EMA/MSs
Project
Team 1
- Audit/
Inspections
EMA TaskForce
17
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
EMA/MSs
Project
Team 5
-Committees/
Referrals
EMA/MSs
Project
Team 6
-Communication/
Transparency
PSUR
Product Info.
Committees
Fees
Lit. monit/
Signal detect.
RMS
PASS/PAES
EV/ADR rep.
Referrals
Com./Transp
Insp./PhV sy.
PhV audits
What will be delivered? (1/2)
Technical contribution to EC implementing measures
Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108
(a) The content and maintenance of the pharmacovigilance
system master file kept by the MAH;
(b) The minimum requirements for the quality system for the
performance of pharmacovigilance activities by the Agency
(the NCAs and MAH);
(c) The use of internationally agreed terminology, formats and
standards for the performance of pharmacovigilance
activities;
18
What will be delivered? (2/2)
Technical contribution to EC implementing measures
Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108
(d) 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;
(e) The format and content of electronic transmission of
suspected adverse reactions by MSs and MAHs;
(f) The format and content of electronic PSURs and RMPs;
(g) The format of protocols, abstracts and final study reports of
the PASS;
19
Implementation of new legislation
Implementation: July 2012
Transitional provisions on:
- Centralised reporting of Periodic Benefit Risk
Reports to EMA
- Centralised reporting to Eudravigilance
Full implementation may take to 2013…..
20
Work is currently in progress
• Major undertaking over the next 18 months (and
beyond)
• Dedicated governance structure for the EU
Regulatory Network has been put in place
• EMA stakeholders forum
• EC public consultation
• Most of the implementation will have to be finalised
by the end of 2012
21
Thank you!
If you want to know more on the role and tasks
of the European Medicines Agency: www.ema.europa.eu
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