I m plem enting the pharm acovigilance legislation: focus on EU level activities 7 th Stakeholders forum on the implementation of the new Pharmacovigilance legislation Peter Arlett, Pharmacovigilance Department, EMA An agency of the European Union 27 September 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
Commission implementing regulation (EU) No 520/ 2012 • Legally binding • 9 Chapters Chapter I I I Chapter I Chapter I I Minim um Pharm acovigilance Minim um requirem ents for the System Master File requirem ents for the m onitoring of data quality system s for in the the perform ance of Eudravigilance pharm acovigilance database activities Chapter I V Chapter V Chapter VI Use of term inology, Transm ission of Risk Managem ent Com m ission form ats and reports of suspected Plans I m plem enting standards adverse reactions Regulation ( EU) No 5 2 0 / 2 0 1 2 Chapter VI I Chapter VI I I Chapter I X Periodic Safety Post-authorisation Final provisions Update Reports Safety Studies 5
Good pharmacoVigilance Practice (GVP) Module I I I Module I Module I I • Self-standing guidance on Pharm acovigilance Pharm acovigilance Pharm acovigilance inspections system s and their system m aster file pharmacovigilance replacing Volume 9A quality system s • Addressed to EU Marketing Authorisation Module VI Module I V Module V Managem ent and Pharm acovigilance Risk m anagem ent reporting of ADRs Holders, Competent Authorities in Member audits system s Publication of Revision 1 as final Q4 2 0 1 3 States and Agency Module VI I Module VI I I Periodic safety update Module I X Post-authorisation reports • Developed within EU network Signal m anagem ent safety studies Publication of Revision 1 as final Q4 2 0 1 3 Good pharm acoVigilance • 8 weeks public consultation Module XI I Module X Module XI Practice ( GVP) Continuous Additional Public participation pharm acovigilance m onitoring Public consultation Public consultation • 2 types of ‘Chapters’: Q2 2 0 1 4 Q1 2 0 1 4 Module XI V Module XVI Module XV •Modules for major processes I nternational Risk m inim isation Safety cooperation m easures •Product or populations specific (P) com m unication Public consultation Publication as final Q1 2 0 1 4 Q4 2 0 1 3 • GVP structure: P I – Vaccines •A: Introduction Publication as final Q4 2 0 1 3 •B: Structures and processes •C: Operation of the EU network Under developm ent Published 6 Public consultation
Prioritised implementation agreed by EMA Management Board in December 2011 and 2012 Not started On-going im plem entation I m plem ented 7
What has been delivered and what is now routine While date period for most of the slides relates to July 2012 to July 2013, a small number of slides use a different data period 8
Prioritised implementation of the pharmacovigilance legislation Collection of key inform ation on m edicines 9
RMP data 10
RMP Data 11
12
Prioritised implementation of the pharmacovigilance legislation 13
PSURs: Outcomes at PRAC 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 14 14
PSURs: Observations • Procedure now better understood by all concerned parties – clear improvements noted. • Increasing number of PSUR procedures leading directly to MA variation – efficiency gains since no need for follow-up variation and health gains through rapid update of product information • Still room for further improvement in terms of better understanding the new procedure: – For regulators: requests for additional information to be more clearly phrased requests for labelling to be explicit and clearly justified – For pharmaceutical industry: key success factor is the provision by companies of clear positions and proposals for regulatory action/ follow-up Further training to be provided 15
Prioritised implementation of the pharmacovigilance legislation Collection of key inform ation on m edicines 16 16 16
135 studies registered: most since July 2012 17
Prioritised implementation of the pharmacovigilance legislation Collection of key inform ation on m edicines 18 18 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 20
Article 57(2) data: business case • Communication with stakeholders – European medicines web portal (search for all human 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) – EU/ international data exchange 21
Article 57(2) Implementation status 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 22
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