New pharm acovigilance legislation: focus on first year of operation PCWP. December 2013 Dr Peter Arlett EMA An agency of the European Union December 2013
In this presentation 1. Objectives, where we have come from: where we are going 2. What has been delivered in 2012 – 2013 and what are now routine activities 3. What remains to be done 4. Moving forward together 1
Where we have come from 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 5 October 2 0 1 2 : Publication of 3 1 Decem ber 2 0 1 0 : Publication Regulation ( EC) 1 0 2 7 / 2 0 1 2 and of Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 1 2 / 2 6 / EU Directive 2 0 0 1 / 8 3 / EC ( entry into force in June and ( entry into force in July 2 0 1 2 ) . October 2 0 1 3 ) . 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 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 2 0 0 6 -2 0 0 8 : Research, consultation, policy development 2 0 0 7 : Commission strategy to strengthen 2 0 0 5 : I ndependent and rationalise study completed to pharmacovigilance 2 0 0 3 : EC decision to map the strengths undertake an and weaknesses of assessment of the the EU system Community system of pharmacovigilance 2
Where we are going: legislation objectives 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 • 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 3
Challenges • Major resource constraints • Size of change • Product lifecycle impacted • Number of stakeholders impacted 4
What has been delivered and what is now routine 5
Pharmacovigilance Risk Assessment Committee Inaugural meeting Brussels July 19-20 th 2012
Membership of PRAC Appointed by Appointed by each Mem ber European State: Com m ission: 6 m em bers - relevant expertise 1 m em ber + alternate including clinical pharm acology 2 8 + EEA countries non and pharm acoepidem iology voting m em bers 1 m em ber/ alternate representing patient organisations 1 m em ber/ alternate representing healthcare professionals
HCP and patient representatives
PRAC volumes (July 2012 – July 2013) 180 160 11 2 5 140 6 11 6 5 120 1 3 6 53 15 16 6 Other safety 1 2 3 100 5 13 33 issues - MS 0 51 2 Other safety 33 30 issues - CHMP 80 8 35 31 PhVig 2 4 Inspections 60 PASS 20 60 64 50 PSURs 57 40 61 45 50 4 34 4 RMPs 0 3 20 10 1 0 17 3 13 7 Signals 10 2 13 15 13 3 10 13 8 2 7 8 7 1 5 4 2 2 2 1 0 1 1 Art.5(3) referrals Sep-12 Nov-12 Jan-13 Mar-13 May-13 Jul-13 9
Transparency of activities for Pharmacovigilance Risk Assessment Committee • 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 10
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Strengthening the science base Methods work – evidence based process improvement Strengthening evidence underpinning individual decisions - increases quality of Opinions
RMP Risk Management Plans – based on safety profile, plan the data collection and risk minimisation 14
PSURs: Periodic Safety Update Reports = benefit risk assessments of marketed products 250 205 200 150 Maintenance CHMP Variation Suspension 100 Revocation 43 50 38 38 30 33 25 19 17 9 9 8 5 3 2 2 0 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Total • 243 PSUR PRAC recommendations (single CAPs) from Dec 2012 till June 2013 • 38 (16% ) PRAC recommendations to vary MA • No suspensions, no revocations 15 15
Example –Strontium ranelate Periodic safety update report identified increased risk of cardiac disorders including MI PRAC advised urgent variation to restrict MA on safety grounds Art 20 referral ongoing
Safety Studies: protocols and results at PRAC 14 13 13 12 11 11 10 9 8 7 PASS 6 6 Protocols 5 PASS 5 Results 4 4 4 3 3 3 2 2 2 2 1 1 0 Sep-12 Oct-12 Nov-12 Dec-12 Jan-13 Feb-13 Mar-13 Apr-13 May-13 Jun-13 Jul-13 17
135 studies registered: most since July 2012 18
Article 57(2) data content Structured Medicinal Product I nform ation: Business Substance I nform ation: Business - P1: MAH (Legal Entity) Service - S1: Substance names Service - P2: QPPV Product Substance - S2: Substance Translations - P3: PhV Enquiries - S3: Substance synonyms - P4: PSMF P - S4: Substance class - P5: Authorisation country code S - P6: Authorisation procedure - S5: Reference source - P7: Authorisation status - S6: International Codes - P8: Authorisation number - P9: Authorisation date - P10: MRP/ DCP/ EU number - P11: Date of withdrawal/ revocation/ suspension Reference Term inology: - P12: Package description -R1: Pharmaceutical form - P13: Orphan drug designation - P14: Comments (e.g. paediatric use) -R2: Route of Administration - P15: Medicinal product name -R3: ATC codes - P16: Medicinal product invented name -R4: Units of Measurement - P17: Product generic name - P18: Product company name -R5: Units of presentation - P19: Product strength name -R6: Reference source - P20: Product form name - P21: Pharmaceutical Form Organisation inform ation: - P22: Route of administration(s) Business -O1: MAH (Legal Entity) Service - P23: Active ingredient(s), Adjuvant(s) Referential - P24: Excipients -O2: QPPV s - P25: Medical device(s) -O3: PhV Enquiries - P26: Strength of active ingredient(s)/ adjuvant(s) R -O4: PhV System Master File - P27: Therapeutic Indication(s) - P28: ATC code Business Unstructured Medicinal Product I nform ation: Service - P29: Summary of Medicinal Product Characteristics Organisation O 19
Article 57(2) data: business case • Better analysis and understanding of data/ information – EudraVigilance data analysis, safety signal detection • Regulatory action to safeguard public health – Support to referral procedures (e.g. interaction with MAHs) – Provision of other PRAC outputs to MAHs – Facilitation of PhV inspections – Longer term (ISO) – quality defects of medicines and counterfeits can be linked to the correct products • Communication with stakeholders – European medicines web portal (search for medicines authorised in the EU) – Publication of lists (work-sharing purposes, products under additional monitoring, PSUR list, list of withdrawn products) – Access to EudraVigilance data (proactive and reactive) 20 – EU/ international data exchange
Article 57(2) Implementation status and next steps As of 23 rd September, MAHs have submitted a total of • 4 4 3 ,0 0 0 medicinal product entries to the Agency. New entries in the XEVMPD are received on a daily basis • The next steps in the Art57 implementation, including strategy and timelines for the kick-off of the maintenance phase, will support the wider EU data architecture strategy… .. 21
‘Black symbol’ for products under additional monitoring (1/ 2) • 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 – initial list published on 25 th April 2013 and updated every month 22
New communication material on additional monitoring (1/ 2) Factsheet + Video • Consultation: EC, HMA WGCP and Project Team 3 involved in preparation • PRAC informed at September meeting • All EU languages • Easily printable • Based on already published information 23 23
Prioritised implementation of the pharmacovigilance legislation 119 Aug-13 Jun-13 The current number of the Jul-13 additionally monitored 111 Jul-13 Aug-13 drugs – 1 1 9 (published 9 Sep-13 August 2013) 106 Jun-13 24 98 100 102 104 106 108 110 112 114 116 118 120
Reporting numbers: Pre and Post legislation 25
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