An agency of the European Union

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

The impact of the newEU Pharmaceutical Legislation on the European Medicines Agency’s ActivitiesVincenzo SalvatoreHead of Legal Service

2

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

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• 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

Status

4

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

5

Avoid overlapping

I will focus on:

- PhV legislation only

- Impact on the Agency’s

activities

I will not address:

- Details of the new legislation

6

PhV Key issues

Enhance high levels of public health protection

while exploiting the potential for:

• Proportionality in the safety requirements

• Simplification

• Increased efficiency in the network

7

Audit / Fees /Small markets

Co-ordinationinspections

TransparencyCommunication

Committees and DMP

PSUR Worksharing

ADRs Signal

detection

MPs subjectto additionalmonitoring

Risk minimisation

Legal basisPASS /

Efficacy Studies

RiskManagement

Plan

Change AuthorisationRequirements

PhV

The PhV Galaxy

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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

- Access in small markets – labelling exemption etc.

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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

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• 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)

                                                                                                                                              

Pharmacovigilance Risk Assessment Committee (PRAC)

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Mandate: All aspects of the risk management of the use of medicines

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Decision-making for PSURs, referrals, PASS

Single AR prepared by the Member State appointed by CMD(h)

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

Decision sent the MAHs and MSs concerned

Position of the majority of MSs to be sent to the Commission which will adopt a decision

Detailed explanations to be annexed. CMD has the legal power

MS ≠

CMD(h) ≠ PRACMS =

“No CAP concerned”

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Decision-making for PSURs, referrals, PASS

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)

“At least 1 CAP concerned”

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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

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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

Guidelines

SOP/WIN/Templates

IT Tools

Impact onEMA and

MSs

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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

Some Key Changes

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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 (…)

EU Medicinal Product Dictionary

Presentation title (to edit, click View > Header and Footer)1717

Project Oversight Committee(ERMS-FG)

Project Coordination

Group

EMA/MSsProject Team 1 - Audit/

Inspections

EMA/MSsProject Team 2PSURs

EMA/MSsProject Team 3

ADR reporting/Additional Monitoring/

-Signals

EMA/MSsProject Team 4-RMP/

PASS/PAES-Effectiveness

of risk Minimisation

EMA/MSsProject Team 5

-Committees/Referrals

EMA/MSsProject Team 6

-Communica-tion/

Transparency

12 EMA Subproject Teams

PSUR

PASS/PAES

Product Info.

EV/ADR rep.

Committees

Referrals

Fees

Com./Transp

Lit. monit/Signal detect.

Insp./PhV sy.

RMS

PhV audits

Governance – EU Network

6 EMA/MSs Subproject Teams

EMA Task-Force

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(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;

Technical contribution to EC implementing measures

Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108

What will be delivered? (1/2)

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(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;

Technical contribution to EC implementing measures

Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108

What will be delivered? (2/2)

2020

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…..

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• 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

Work is currently in progress

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Thank you!

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