Update on im plem entation of Pharm acovigilance legislation EU2 8 - - PowerPoint PPT Presentation

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Update on im plem entation of Pharm acovigilance legislation EU2 8 - - PowerPoint PPT Presentation

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Update on im plem entation of Pharm acovigilance legislation EU2 8 : Science Medicines Health, a regulatory system fit for the future 06-07 May 2013, Dubrovnik, Croatia Franck Diafouka, Pharmacovigilance and Risk Management Sector, Patient

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An agency of the European Union

Update on im plem entation of Pharm acovigilance legislation

EU2 8 : Science Medicines Health, a regulatory system fit for the future 06-07 May 2013, Dubrovnik, Croatia Franck Diafouka, Pharmacovigilance and Risk Management Sector, Patient Health Protection Unit European Medicines Agency

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1

  • 1. Making of the law and its objectives
  • 2. Hierarchy of rules
  • 3. Prioritised implementation for 2013
  • 4. Project governance structure

Content

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2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance
  • 1. The making of the law and its objectives
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2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance

2 0 0 5 : I ndependent study completed to map the strengths and weaknesses of the EU system

  • 1. The making of the law and its objectives
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2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance

2 0 0 5 : I ndependent study completed to map the strengths and weaknesses of the EU system 2 0 0 7 : Commission strategy to strengthen and rationalise pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development

  • 1. The making of the law and its objectives
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2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance

2 0 0 5 : I ndependent study completed to map the strengths and weaknesses of the EU system 2 0 0 7 : Commission strategy to strengthen and rationalise pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament

  • 1. The making of the law and its objectives
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2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance

2 0 0 5 : I ndependent study completed to map the strengths and weaknesses of the EU system 2 0 0 7 : Commission strategy to strengthen and rationalise pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament 3 1 Decem ber 2 0 1 0 : Publication

  • f Regulation ( EC) 7 2 6 / 2 0 0 4 and

Directive 2 0 0 1 / 8 3 / EC ( entry into force in July 2 0 1 2 ) .

  • 1. The making of the law and its objectives
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SLIDE 8

2 0 0 3 2 0 0 4 2 0 0 5 2 0 0 6 2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3

2 0 0 3 : EC decision to undertake an assessment of the Community system

  • f pharmacovigilance

2 0 0 5 : I ndependent study completed to map the strengths and weaknesses of the EU system 2 0 0 7 : Commission strategy to strengthen and rationalise pharmacovigilance 2 0 0 6 -2 0 0 8 : Research, consultation, policy development Decem ber 2 0 0 8 : ‘Pharma package’ (Pharmacovigilance, I nformation to patients and falsified medicines) adopted by the European Commission and transmitted to Council and European Parliament to start the co-decision procedure for pharmacovigilance Decem ber 2 0 0 8 - 2 2 Septem ber 2 0 1 0 : Co-decision procedure until final favourable vote in the European Parliament 3 1 Decem ber 2 0 1 0 : Publication

  • f Regulation ( EC) 7 2 6 / 2 0 0 4 and

Directive 2 0 0 1 / 8 3 / EC ( entry into force in July 2 0 1 2 ) . 2 5 October 2 0 1 2 : Publication of Regulation ( EC) 1 0 2 7 / 2 0 1 2 and Directive 2 0 1 2 / 2 6 / EU ( entry into force in June and October 2 0 1 3 ) .

  • 1. The making of the law and its objectives
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8

Promote and protect public health by reducing burden of Adverse Drug Reactions and optimising the use of medicines:

  • Clear roles and responsibilities
  • Science based
  • Risk based/ proportionate
  • Increased proactivity/ planning
  • Reduced duplication/ redundancy
  • Integrate benefit and risk
  • 1. The making of the law and its objectives
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9

Promote and protect public health by reducing burden of Adverse Drug Reactions and optimising the use of medicines:

  • 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
  • 1. The making of the law and its objectives
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10

Regulation ( EC) No 7 2 6 / 2 0 0 4 Directive 2 0 0 1 / 8 3 / EC EC I m plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Good pharm acoVigilance Practice ( GVP)

10

  • 2. Hierarchy of rules
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  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

  • Legally binding
  • 9 Chapters
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SLIDE 13
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File

  • Legally binding
  • 9 Chapters
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SLIDE 14
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities

  • Legally binding
  • 9 Chapters
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SLIDE 15
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database

  • Legally binding
  • 9 Chapters
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SLIDE 16
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards

  • Legally binding
  • 9 Chapters
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SLIDE 17
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards Chapter V Transm ission of reports of suspected adverse reactions

  • Legally binding
  • 9 Chapters
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SLIDE 18
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards Chapter V Transm ission of reports of suspected adverse reactions Chapter VI Risk Managem ent Plans

  • Legally binding
  • 9 Chapters
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SLIDE 19
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards Chapter V Transm ission of reports of suspected adverse reactions Chapter VI Risk Managem ent Plans Chapter VI I Periodic Safety Update Reports

  • Legally binding
  • 9 Chapters
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SLIDE 20
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards Chapter V Transm ission of reports of suspected adverse reactions Chapter VI Risk Managem ent Plans Chapter VI I Periodic Safety Update Reports Chapter VI I I Post-authorisation Safety Studies

  • Legally binding
  • 9 Chapters
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SLIDE 21
  • 2. Hierarchy of rules - Commission

implementing regulation (EU) No 520/ 2012

Com m ission I m plem enting Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter I Pharm acovigilance System Master File Chapter I I Minim um requirem ents for the quality system s for the perform ance of pharm acovigilance activities Chapter I I I Minim um requirem ents for the m onitoring of data in the Eudravigilance database Chapter I V Use of term inology, form ats and standards Chapter V Transm ission of reports of suspected adverse reactions Chapter VI Risk Managem ent Plans Chapter VI I Periodic Safety Update Reports Chapter VI I I Post-authorisation Safety Studies Chapter I X Final provisions

  • Legally binding
  • 9 Chapters
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  • 2. Hierarchy of rules - Good

pharmacoVigilance Practice (GVP)

  • Self-standing guidance on

pharmacovigilance replacing Volume 9A

  • Addressed to EU Marketing

Authorisation Holders, Competent Authorities in Member States and Agency

  • Developed within EU network
  • 8 weeks public consultation
  • 2 types of ‘Chapters’:
  • Modules for major processes
  • Product or populations specific (P)
  • GVP structure:
  • A: Introduction
  • B: Structures and processes
  • C: Operation of the EU network

21

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  • 2. Hierarchy of rules - Good

pharmacoVigilance Practice (GVP)

Good pharm acoVigilance Practice ( GVP) Module I Pharm acovigilance system s and their quality system s Module I I Pharm acovigilance system m aster file Module I I I Pharm acovigilance inspections

  • Self-standing guidance on

pharmacovigilance replacing Volume 9A

  • Addressed to EU Marketing

Authorisation Holders, Competent Authorities in Member States and Agency

  • Developed within EU network
  • 8 weeks public consultation
  • 2 types of ‘Chapters’:
  • Modules for major processes
  • Product or populations specific (P)
  • GVP structure:
  • A: Introduction
  • B: Structures and processes
  • C: Operation of the EU network

Module I V Pharm acovigilance audits Module V Risk m anagem ent system s Module VI Managem ent and reporting of adverse reactions Module VI I Periodic safety update reports Module VI I I Post-authorisation safety studies Module I X Signal m anagem ent Module X Additional m onitoring Module XV Safety com m unication

22

Under developm ent Public consultation Published

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SLIDE 24
  • 2. Hierarchy of rules - Good

pharmacoVigilance Practice (GVP)

Good pharm acoVigilance Practice ( GVP) Module I Pharm acovigilance system s and their quality system s Module I I Pharm acovigilance system m aster file Module I I I Pharm acovigilance inspections

  • Self-standing guidance on

pharmacovigilance replacing Volume 9A

  • Addressed to EU Marketing

Authorisation Holders, Competent Authorities in Member States and Agency

  • Developed within EU network
  • 8 weeks public consultation
  • 2 types of ‘Chapters’:
  • Modules for major processes
  • Product or populations specific (P)
  • GVP structure:
  • A: Introduction
  • B: Structures and processes
  • C: Operation of the EU network

Module I V Pharm acovigilance audits Module V Risk m anagem ent system s Module VI Managem ent and reporting of adverse reactions Module VI I Periodic safety update reports Module VI I I Post-authorisation safety studies Module I X Signal m anagem ent Module X Additional m onitoring Module XVI Risk m inim isation m easures Module XV Safety com m unication P I – Vaccines ( opened 1 2 / 0 4 / 1 3 )

23

Under developm ent Public consultation Published

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SLIDE 25
  • 2. Hierarchy of rules - Good

pharmacoVigilance Practice (GVP)

Good pharm acoVigilance Practice ( GVP) Module I Pharm acovigilance system s and their quality system s Module I I Pharm acovigilance system m aster file Module I I I Pharm acovigilance inspections

  • Self-standing guidance on

pharmacovigilance replacing Volume 9A

  • Addressed to EU Marketing

Authorisation Holders, Competent Authorities in Member States and Agency

  • Developed within EU network
  • 8 weeks public consultation
  • 2 types of ‘Chapters’:
  • Modules for major processes
  • Product or populations specific (P)
  • GVP structure:
  • A: Introduction
  • B: Structures and processes
  • C: Operation of the EU network

Module I V Pharm acovigilance audits Module V Risk m anagem ent system s Module VI Managem ent and reporting of adverse reactions Module VI I Periodic safety update reports Module VI I I Post-authorisation safety studies Module I X Signal m anagem ent Module X Additional m onitoring Module XI Public participation ( Q3 2 0 1 3 ) Module XI I Continuous pharm acovigilance ( Q3 2 0 1 3 ) Module XI V I nternational cooperation ( Q3 2 0 1 3 ) Module XVI Risk m inim isation m easures Module XV Safety com m unication P I – Vaccines ( opened 1 2 / 0 4 / 1 3 )

24

Under developm ent Public consultation Published

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25

  • 3. Prioritised implementation agreed by EMA

Management Board in December 2011 and 2012

  • Criteria for prioritisation:

– Firstly, public health activities – Secondly, transparency and communication activities – Thirdly, simplification activities (primarily for pharmaceutical industry)

  • Activities grouped into four m ain topic areas:

– Collection of key information on medicines – Better analysis and understanding of data and information – Regulatory action to safeguard public health – Communication with stakeholders

  • Traffic light:

Not started On-going im plem entation I m plem ented New activities

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SLIDE 27

26

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Collection of key inform ation on m edicines ( 1 / 4 )

1 . Risk Managem ent Plans: 2 0 1 2 2 0 1 3 Establishment and operation of new procedure for requesting and assessing RMP

  • Started July 2012
  • Templates for industry

(Oct)

  • Format compulsory (Jan

2013) 2 . Periodic Safety Update Reports ( PSUR) : Operation of new procedures related to PSURs for CAPs*

  • Started July 2012

Development, maintenance and publication

  • f harmonised birthdates to support PSUR

submission

  • First list published in Oct

2012 (monthly update) Handling of PSURs for active substances contained in both CAPs and NAPs* in accordance with URD* list

  • To start as of April 2013
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SLIDE 28

27

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Collection of key inform ation on m edicines ( 2 / 4 )

3 . Post-Authorisation Safety and Efficacy Studies: 2 0 1 2 2 0 1 3 Implementation of the PASS procedure for protocols approval and results management for CAPs

  • Started July 2012

Public consultation on delegated act on PAES by the Commission

  • From 28/ 11/ 2012 to

18/ 02/ 13 PASS: Operate the procedure for initial protocol and protocol amendment endorsement and results management for NAPs PASS: Establish a procedure to encourage MAHs to collaborate on PASS affecting multiple medicinal products PAES: Deliver scientific guidance on methodological aspects (expert workshop)

27

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SLIDE 29

28

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Collection of key inform ation on m edicines ( 3 / 4 )

4 . Electronic subm ission of core m edicine

inform ation by MAHs ( ‘Article 5 7 ’) : 2 0 1 2 2 0 1 3

Start validation of received information Initiate limited quality assurance of data being submitted on medicinal products authorised in EU Achieve an agreement with pharmaceutical industry on the submission of varied marketing authorisations in view of operating the process for submission of maintenance data at a later stage

28

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29

GVP developm ent

Format for electronic submission of product information – phased implementation

Phase One Phase Three Phase Tw o Phase Four

Notification of electronic subm ission form at

  • Published in July

2 0 1 1 / revised in March 2 0 1 2

  • xEVMPD w eb-

application released in March 2 0 1 2

  • Detailed guidance,

Questions & Answ ers, set of Controlled Vocabularies

Electronic subm ission and data processing

Subm ission of core set of structured data by MAHs

  • I nitial data subm ission for

all m edicinal products authorised in EU

  • Data subm ission of new

m arketing authorisations granted in the EU after 2 July 2 0 1 2 Processing of Article 5 7 ( 2 ) data by EMA

I nitiation of quality review and m aintenance of Article 5 7 ( 2 ) data I m plem entation of I SO standards

NOTE: Dedicated helpdesks: art57@ema.europa.eu and eudravigilance@ema.europa.eu

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Format for electronic submission of product information – ISO IDMP Standards

I SO I DMP Standards

(finalised in October 2012) ISO 11615: 2012, Health Informatics, Identification of Medicinal Products standard

Data elements and structures for unique identification and exchange of regulated medicinal product information

ISO 11616: 2012, Health Informatics, Identification of Medicinal Products standard

Data elements and structures for unique identification and exchange of regulated pharmaceutical product information

ISO 11240: 2012, Health Informatics, Identification of Medicinal Products standard

Data elements and structures for unique identification and exchange of units of measurements

ISO 11239: 2012, Health Informatics, Identification of Medicinal Products standard

Data elements and structures for unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

ISO 11238: 2012, Health Informatics, Identification of Medicinal Products standard

Data elements and structures for unique identification and exchange of regulated information on substances

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31

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Collection of key inform ation on m edicines ( 3 / 4 )

4 . Electronic subm ission of core m edicine

inform ation by MAHs ( ‘Article 5 7 ’) : 2 0 1 2 2 0 1 3

Start validation of received information Initiate limited quality assurance of data being submitted on medicinal products authorised in EU Achieve an agreement with pharmaceutical industry on the submission of varied marketing authorisations in view of operating the process for submission of maintenance data at a later stage

31

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SLIDE 33

32

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Collection of key inform ation on m edicines ( 4 / 4 )

5 . Reporting by patients:

2 0 1 2 2 0 1 3 Cooperation with Member States to provide information to patients on direct reporting

  • Core data fields agreed by

Member States (June 2012) Prepare guidance on patient reporting in cooperation with the Member States 6 . List of m edicines w ithdraw n for safety reasons: Develop a business process for establishing, maintaining and publishing such list Based on 2012 changes to pharmacovigilance legislation

32

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SLIDE 34

33

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Better analysis/ understanding of data and inform ation ( 1 / 2 )

1 . EudraVigilance and signal detection 2 0 1 2 2 0 1 3 Operation of revised signal detection process for CAPs

  • Started July 2012

Support Member States to operate the new EU signal detection processes for NAPs

  • Started July 2012
  • Signal work-sharing list

published (Oct 2012) Start of signal management through the Pharmacovigilance and Risk Assessment Committee (PRAC)

  • Started Sept 2012

Continuation of maintenance work for the current EV system including data quality

  • As planned

Implementation of web-publishing of adverse reaction data (further to the EV Access Policy)

  • Delivered in May 2012

Perform analyses of EV data for NAPs (in collaboration with MSs Competent Authorities through work-sharing)

33

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SLIDE 35

34

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Better analysis/ understanding of data and inform ation ( 2 / 2 )

2 . Additional m onitoring: 2 0 1 2 2 0 1 3 Develop and publish the list of medicines with additional monitoring status

  • Initial list published on 25

April 2013 Monitor that product information for relevant CAPs is updated to reflect this status 3 . I T system s to support processing and analysis of data: Finalisation of business requirements for enhanced IT systems On-going in 2013 4 . Medication errors: Establish guidance/ best practice considerations on medication error prevention and reporting

  • Following stakeholder

workshop held on 28/ 02/ 13-01/ 03/ 13

34

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SLIDE 36

‘Black symbol’ for products under additional monitoring

  • Black symbol:

– Selected by the European Commission following a recommendation of the PRAC (after involving stakeholders) on 7 March 2013 – Inverted equilateral black triangle

  • New text in Product Information

– SPC text: < { Black symbol} > This medicinal product is subject to additional monitoring. This is to allow any safety information to be identified rapidly. Healthcare professionals are encouraged to report any suspected adverse reactions. See section 4.8.> – PL text: < { Black symbol} This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

  • List of products under additional monitoring

– Prepared by the EMA/ PRAC: initial list published on 25th April 2013 and updated every month

  • In April 2013, launch of wide public communication campaign coordinated by

EMA

35

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SLIDE 37

36

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Better analysis/ understanding of data and inform ation ( 2 / 2 )

2 . Additional m onitoring: 2 0 1 2 2 0 1 3 Develop and publish the list of medicines with additional monitoring status

  • Initial list published on 25

April 2013 Monitor that product information for relevant CAPs is updated to reflect this status 3 . I T system s to support processing and analysis of data: Finalisation of business requirements for enhanced IT systems On-going in 2013 4 . Medication errors: Establish guidance/ best practice considerations on medication error prevention and reporting

  • Following stakeholder

workshop held on 28/ 02/ 13-01/ 03/ 13

36

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SLIDE 38

37

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Regulatory action to safeguard public health ( 1 / 2 )

1 . Scientific com m ittees and decision- m aking: 2 0 1 2 2 0 1 3 Establishment and running of new committee (PRAC) and new responsibilities for CMD(h)

  • Established July 2012

PRAC outputs: establish a strategy for supporting PRAC assessments and recommendations with best evidence, including aspects of effectiveness of risk minimisation/ impact of regulatory action 2 . Strengthening referral procedures: Operation of new referral procedure (Urgent Union Procedure)

  • First referral launched in

Oct 2012 Redesign the 2012 implemented procedure and business process to include 2012 changes

37

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SLIDE 39

PRAC workload

38

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SLIDE 40

39

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Regulatory action to safeguard public health ( 2 / 2 )

3 . Pharm acovigilance I nspections: 2 0 1 2 2 0 1 3 Develop and implement a revised process for the coordination of pharmacovigilance inspections

39

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SLIDE 41

40

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Com m unication w ith stakeholders ( 1 / 2 )

1 . Online publishing of inform ation:

2 0 1 2 2 0 1 3 Publication (on EMA website) of agendas, minutes, assessments, approvals, recommendations, opinions and decisions of PRAC, CMD(h) and CHMP .

  • Started July 2012 for

PRAC agendas and minutes Publish agendas and minutes of CHMP meetings 2 . Coordination of safety m essages: Operation of the coordination of Member States’ safety announcements for non-CAPs.

  • Started July 2012

3 . Public hearings: Develop concept of public hearings (incl. criteria and methodologies)

  • Status in April 2013

Introduction of public hearings in the context

  • f Urgent Union Procedure
  • Status in April 2013

40

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SLIDE 42

Legal notice: EMA website serves as the EU Medicines Web-portal

  • Agenda is published on Day 1 of PRAC by mid-day
  • Meeting highlights are published on Friday of PRAC week
  • Safety referrals are published on Friday of PRAC week
  • Minutes are published on the following month after adoption

Transparency of activities for Pharmacovigilance Risk Assessment Committee

41

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SLIDE 43

42

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA

Com m unication w ith stakeholders ( 2 / 2 )

4 . Risk Managem ent Plans sum m aries:

2 0 1 2 2 0 1 3 Agree modalities to publish summary information for RMPs 5 . European Medicines w eb-portal: Initiate research and design work

42

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SLIDE 44

43

  • 3. Prioritised implementation of the

pharmacovigilance legislation by the EMA: beyond 2013…

Topics Activities

Literature monitoring Outsourcing and population of EudraVigilance with case reports. EudraVigilance Delivery of enhanced functionalities and IT system audit (Q4 2015 at least due to delayed development work). Article 57(2) data submission and handling Quality check and publication of controlled structured lists of medicinal products, substances and other key controlled terms. Periodic Safety Update Reports Delivery of PSUR repository and single PSUR assessment process for NAPs with input from analyses

  • f ADR data.

Risk Management System Define key indicators for measuring the effectiveness

  • f risk minimisation and establish monitoring system

Transparency and communication Delivery of EU Medicines web-portal and public hearings outside Urgent Union Procedure.

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SLIDE 45
  • 4. Project Governance structure -

2011/ 2012 Project Governance Structure

44

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

NB:

  • EMA MB
  • HMA
  • ICT Groups
  • ICT Directors
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SLIDE 46
  • 4. Project governance structure –

revised Project Governance Structure

  • Key drivers:

– Complete development of remaining deliverables as per prioritised implementation agreed with EMA MB in Dec 2011 and 2012 – Further integrated, streamlined and efficient implementation recognising the need for process efficiency and resource availability across the EU Network – Enhanced communication, information sharing and cross working across Project Teams as well as Stakeholders liaison management – Improved management and resolution of issues and gaps – Emphasis on NAPs-related issues – Reviewed Project groups membership, considering membership of ICT experts – Better integration and best use of available resources

45

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SLIDE 47
  • Environmental factors:

– DG SANCO proposal for Joint Action on Pharmacovigilance to support Member States to find solutions for organising and running their pharmacovigilance system in the context of the new pharmacovigilance legislation in the EU (unlikely to have operational impact before Q4 2013) – Resources constraints across the EU Network – New changes to Pharmacovigilance legislation – On-going changes to variations and fees regulations

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  • 4. Project governance structure –

revised Project Governance Structure

slide-48
SLIDE 48

Project Coordination Group EMA/ MSs Project Team 1

Collection of key inform ation on m edicines

Training Content Group Pharmacovigilance Audit Facilitation Group

  • EV
  • ‘e-submission’

activities

  • Patient reporting

EMA/ MSs Project Team 2

Better analysis and understanding of data and inform ation

  • Signal
  • RMP/ PSUR
  • PASS/ PAES
  • Additional

monitoring

EMA/ MSs Project Team 3

Com m ittees and Com m unication w ith stakeholders

  • Online publishing
  • f information
  • Coordination of

safety messages

  • Public hearings
  • Referrals -

Transparency/ Prod uct information

Pharmacovigilance I nspectors Working Group

Direct reporting Liaison Project Team s

Signal Management Review Team (SMART WG)

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Project Oversight Com m ittee ( ERMS-FG) Heads of Medicines Agencies BEMA SG

Project Managem ent Office

  • 4. Project governance structure –

revised Project Governance Structure

slide-49
SLIDE 49

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Thank you! Any question?