The New EU PV Legislation: View from the European Commission

Transcription

1 The New EU PV Legislation: View from the European Commission International seminar 26 May 2011 Lenita LINDSTRÖM Senior Policy Officer Pharmaceuticals Unit/DG SANCO

2 Rationale for the revision Calls for the rationalisation of the existing framework Resources focused on administrative compliance should be reoriented to public health protection Duplicative reporting and assessments calls for efficiency gains and work-sharing Scope to increase harmonisation, proportionality, simplification, transparency, use of IT

3 Main steps 2003 Decision to undertake an assessment of the Community system of PhV 2005 Independent study completed 2006 Commission public consultation 2007 Commission strategy announced and second public consultation 2008 Adoption of legal proposal 2010 Adoption of new legislation

4 New PhV legislation New legislation published on 31/12/2010 Regulation (EU) No 1235/2010 of the EP and of the Council of 15 December 2010 amending Regulation (EC) No 726/2004 Directive 2010/84/EU of the EP and of the Council of 15 December 2010 amending Directive 2001/83/EC Applicable from July 2012

5 Key achievements Clear tasks and responsibilities for all parties Improved EU decision-making procedures (harmonised decisions and efficient use of resources) Proactive and proportionate risk management Higher quality of safety data Stronger link between safety assessments and regulatory action Strengthened transparency, communication and patient involvement

6 Tasks and responsibilities: EMA Coordinating role at the centre of EU PhV system (e.g. signal detection, safety announcements, inspections) New Pharmacovigilance Risk Assessment Committee (advising CHMP and CMD) Certain new tasks (e.g. literature monitoring) Important role in the implementation of the legislation (good vigilance practices)

7 Tasks and responsibilities: Member States Maintain key role in the conduct of PhV for products placed on their markets, signal detection and follow up with MAH, healthcare professionals and patients Operation of a pharmacovigilance system Provisions for increased cooperation and worksharing within the network of authorities (incl. possibility to delegate) New mandate of CMD

8 Tasks and responsibilities: Marketing authorisation holders Operation of a PhV system documented in a PhV master file (not included in the MAA) Risk management system for all new products Continuous monitoring of safety information (all information available, incl. clinical trials or use outside SPC) Continuous update of MA

9 Risk management Risk management plan for all products, proportionate to risks and information available Clarification of legal basis to grant a MA subject to conditions (including post-authorisation safety or efficacy studies) Proactive monitoring and signal detection Oversight of non-interventional post-authorisation safety studies

10 Adverse drug reaction reporting Eudravigilance eventually becomes single point for collection and sharing of ADR reports Same reporting rules for nationally and centrally authorised products Reporting not limited to adverse effects in normal conditions of use (medication errors, overdose) Direct patient reporting Literature monitoring by EMA

11 Periodic safety update reports Analysis of benefit-risk vs. line listings of adverse reactions Reporting requirements proportional to risks EU reference dates for a harmonised frequency of reporting & single assessment (products authorised in more than one MS, and products containing the same active substance) Rules to ensure the harmonised regulatory followup as regards the MA

12 EU decision-making Existing procedures maintained and stream-lined (Arts 31 and 107 of the Directive, 20 of the Regulation) Stream-lined Art 107 procedure Clarification of criteria initiating the procedure Scope of procedure to cover all products concerned to ensure single assessment of the safety issue Procedural novelties (public hearings) Harmonised regulatory follow-up after safety assessments New roles for CHMP, CMD, PRAC

13 Transparency, Communication, patient involvement Access to Eudravigilance European and national medicines web portals Coordination by EMA of communications on safety issues List of products under additional monitoring Invitation to report ADRs included in product information

14 Implementation: Commission Revision of the Fees regulation Implementing measures (7) Delegated act on efficacy studies (1 may provision) Reports (i) readability of product information PIL/SPCs (ii) environmental effect of medicines Selection of black symbol for SPC/PIL for additional monitored products Nomination of PRAC members

15 Implementation: EMA Eudravigilance functionalities PSUR repository Guidance: good vigilance practices scientific guidelines on efficacy studies Medicines web-portal Rules of Procedure (public hearings, PRAC)

16 Implementation: Member States Transposition into national law Nomination of PRAC members and revised role of CMD member Setting up of medicines web portal

17 Implementation: Marketing authorisation holders Consider transitional provisions to clarify the application of new obligations to existing MAs Consider new rules for applications for MA in coming months Integrate new rules in PhV planning and management

18 Evaluation An evaluation of the new pharmacovigilance legislation has been carried out in the light of the Mediator case. Certain points for possible improvement have been identified and currently, there are reflections on ways to address this in a proposal

19 Thank you! human-use/index_en.htm