PRAC ny EMA kommitté för säkerhetsövervakning

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1 PRAC ny EMA kommitté för säkerhetsövervakning och riskbedömning av läkemedel Qun-Ying Yue, PhVWP delegat/prac ledamot (nominerad) LVs Farmakovigilansdagar, 4-5 juni, What the legislation sets out to achieve: Promote and protect public health by reducing burden of ADRs and optimising the use of medicines: Clear roles and responsibilities Engage patients and healthcare professionals Science based - integrate benefit and risk Stronger / more robust assessments based on best evidence Better expertise to support decision-making Robust and rapid EU decision-making Rapid information to patients and HCPs Rapid risk minimisation through binding outcomes 2 1

2 Scope of Changes Coordination / lists of Periodic Safety Update medicines Reports Authorisation requirements Scientific Committees / PRAC Risk Management Plans / decision-making Post-Authorisation Studies Transparency and (Safety and Efficacy) communication Effectiveness of risk minimisation Coordination of inspections Adverse Drug Reactions reporting Signal detection Pharmacovigilance il Audits Fees charged and payments for assessments / services Starting point: EU No 1235/2010 and Dir 2010/84/EU The PRAC is created to ensure the availability of necessary expertise and resources for the pharmacovigilance assessment at Union level (8) The PRAC should give a recommendation as part of any Union wide post authorisation assessment based on PhV data and it should be responsible for making recommendations on risk management systems and monitoring their effectiveness (11) The mandate of the PRAC shall cover all aspects of the risk management of the use of medicinal products for human use including the detection, ti assessment, minimisation i i and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product for human use, the design and evaluation of post-authorisation safety studies and pharmacovigilance 4 audit. (Art 61(a) (6)) 2

3 PRAC - Pharmacovigilance Risk Assessment Committee Ny vetenskaplig kommitté (PRAC) inrättas på EMA juli 2012 (Pharmacovigilance Working Party - PhVWP upphör) PRACs mandat omfattar alla aspekter av säkerhetsövervakning k och riskbedömning läkemedel RMPs PSURs PASS studier Safety referrals signaler Koordination av säkerhetsinformation mm (renewals, annual reassessments, safety type II variations on a case by case basis) 5 Identified PRAC Activities (1/2) Activity Risk Management Systems Periodic Safety Update Reports PSURs Eudravigilance + Periodic Safety Update Reports repository Medicines subject to additional monitoring Signal Detection Involvement Agreement on RMPs + monitoring their effectiveness List of harmonised submission frequencies and substances, assessment + recommendation Functional specifications, any substantial changes Addition to/removal from list, extension of timeframe, symbol 6Initial analysis + prioritisation assessment + recommendations 3

4 Identified PRAC Activities (2/2) Activity Urgent Safety Procedures for the EU Post Authorisation Safety Studies Literature Adverse Drug Reactions monitoring Involvement Assessment, public hearings, recommendations Consultations on requests (pre and post MA), assessment of protocols (incl. amendments) + recommendations, assessment of results + recommendations Consultation on list of active substances and medical literature subject to monitoring Safety announcements 7 Advice on request of EMA PRAC Pharmacovigilance Risk Assessment Committee 1 ledamot (plus 1 suppleant) / medlemsstat utses av nationell myndighet (SE: Qun-Ying Yue, Ulla Wändel-Liminga) 6 ledamöter (oberoende vetenskapliga experter) utses av EC 1 ledamot (plus 1 suppleant) som företräder sjukvårdspersonal utses av EC 1 ledamot (plus 1 suppleant) som företräder patientorganisationer utses av EC 4

5 PRAC activities and expertise needed Risk detection / signal detection Pharmacovigilance audit Design and Evaluation of post authorisation safety studies Risk assessment Risk and therapeutic effect assessment Risk minimisation (regulatory action) and analysis of impact of risk minimisation 9 Communication of risk and benefit/risk 8 PRAC activities and expertise needed Additional (specialised) Areas Additional (specialised) Areas 10 Drug safety in pregnancy and lactation Drug utilisation studies Medication errors leading to ADRs Pharmacogenetics and safety of medicines PhV in special populations (paediatrics, elderly) PhV of biological and biosimilar substances PhV and quality defects PhV of Vaccines Specialised clinical areas for Adverse Drug Reactions 5

6 PRACs rekommendation (Art 107j) ska omfatta en/fler av följande punkter a) inga fler utvärderingar eller åtgärder på unionsnivå i behövs b) företaget bör göra ytterligare utvärdering av uppgifterna c) företaget bör genomföra en PASS studie d) riskminimerande åtgärder bör vidtas e) marknadsföringstillståndet bör återkallas tillfälligt, upphävas eller inte förnyas f) produktinformationen bör ändras 11 PRACs rekommendationer PRACs rekommendationer går till CHMP resp CMD(h) för yttrande/beslut inom 30 dagar publiceras på EMAs hemsida CHMP resp CMD(h) ska förlita sig på PRACs rekommendationer vad gäller säkerhetsfrågor O CHMP / CMD(h) h ik d f tt i Om CHMP / CMD(h) har en avvikande uppfattning måste en detaljerad redogörelse för den vetenskapliga grunden för detta göras publik 6

7 PRAC recommendations CMDh Immediate Position or within 30 days CHMP Immediate Opinion or within 30 days Agreement by consensus Position by majority Adoption of Opinion (variation, suspension, revocation, refusal of renewal) Adoption of Agreement (variation, suspension, revocation, refusal of renewal + Timetable for MS implementation European Commission Commission Decision PRAC and Transparency Regulation EU 1235/2010 states that in order to increase transparency as regards as pharmacovigilance il issues a European medicines i web portal should be created and maintained by the Agency in collaboration with Members States and the Commission Agenda & Minutes Assessments 1 4 Decisions Opinions i Agreements Positions Recommendation s Available to the public 7

8 Timelines: Q Appointment of members and alternates by Member States Q Management Board and Commission on composition of PRAC 1 st Meeting of PRAC Brussels 19 and 20 July 2012:Organisational Rules of procedure Conflicts of interest Elect Chair Following meetings 2012 two-weeks before CHMP/CMDh Sept t3456 3,4,5,6 Oct 1,2,3,4 Oct 29,30,31 Nov 26,27,28, Further details are under discussion / development Rapporteurship appointment Business Process Maps stakeholders involved (WHAT and WHERE), processes (WHAT TO DO), Timelines (WHEN) where appropriate and Inputs/Outputs (WHAT). Development/update of templates Subject to amendment as further policy/strategic aspects get clarified (e.g. Rapporteur ship appointment) 8