1. An agency of the European Union Budapest, 13 May 2011 The views expressed in this presentation are those of the author only. They do not necessarily reflect and cannot be quoted as the views of the European Medicines Agency The impact of the new EU Pharmaceutical Legislation on the European Medicines Agency’s Activities Vincenzo Salvatore Head of Legal Service

2. 2 What is it all about A strengthened EU system for monitoring of medicinal products New tools to reduce the likelihood of falsified products in the legal supply chain A modified proposal on non promotional information on medicinal products to be provided to patients How the European Medicines Agency is affected by the new legislation and how it is preparing for its implementation

3. 3 Pharmacovigilance:  Regulation (EU) No 1235/2010  Directive 2010/84/EU Falsified medicines:  Approved by the EP on 16/2/2011 Information to patients:  Modified proposal awaited Status

4. 4 Pharma package objectives To better protect patients by strengthening the EU pharmacovigilance system To enable citizens to get high-quality information on medicines To tackle the growing issues of counterfeiting and illegal distribution of medicine

5. 5 Avoid overlapping I will focus on: - PhV legislation only - Impact on the Agency’s activities I will not address: - Details of the new legislation

6. 6 PhV Key issues Enhance high levels of public health protection while exploiting the potential for: Proportionality in the safety requirements Simplification Increased efficiency in the network

7. 7 PhV Change Authorisatio n Requirement s Risk Management Plan Legal basis PASS / Efficacy Studies Risk minimisation MPs subject to additional monitoring ADRs Signal detection PSUR Worksharing Committees and DMP Transparenc y Communicati on Co- ordination inspections Audit / Fees / Small markets The PhV Galaxy

8. 88 Scope of changes…everything in one slide! -Authorisation requirements change (PSMF, key risk management measures in MA) -Risk Management Plan, risk proportionate and for all new products (+justified old) -Legal basis for PASS + legal basis for efficacy studies (PAES) -Effectiveness of risk minimisation -Product information change – ‘additional monitoring’ + encourages ADR reporting -ADR reporting simplified + patient reporting + medication errors + role of EV + literature monitoring + reporting to WHO -Signal detection has clear roles and responsibilities -PSUR submission simplified (electronic) and single assessment + benefit: risk -New PRAC Committee and its interaction with CMD(h)/CHMP) in decision-making process -Transparency and communication (webportals, EV access, coordinate MSs, hearings) -Enhanced coordination of inspections -Regular EMA and MS + MAH audit -Fees for pharmacovigilance -Access in small markets – labelling exemption etc.

9. 9 Impact on the EMA Strengthened coordinating role in the Pharmacovigilance system Creation of a new Committee: the Pharmacovigilance Risk Assessment Advisory Committee (PRAC) Creation of European medicines webportal Eudravigilance database as single point of receipt of pharmacovigilance information: accessible to MSs, EMA and Commission and partially also to MAHs and the public Signal detection of new/changed risks in Eudravigilance + literature monitoring Together with MS monitor the outcome of risk minimisation measures

10. 10 Chairman & Vice-Chairman 1 scientific expert member nominated by each MS and 1 alternate 6 members appointed by European Commission 1 member representing Health Care professionals + 1 alternate (appointed by EC) 1 member representing Patients Associations + 1 alternate (appointed by EC) Possibility of delegation of activities by MS in another MS (max 1 representation by MS) Pharmacovigilance Risk Assessment Committee (PRAC) 6 Mandate: All aspects of the risk management of the use of medicines

11. 11 Decision-making for PSURs, referrals, PASS Single AR prepared by the Member State appointed by CMD(h) PRAC to adopt the AR If any regulatory action results from the AR, CMD to reach a position: maintenance, variation, suspension or revocation + according timetable for implementation Decision sent the MAHs and MSs concerned Position of the majority of MSs to be sent to the Commission which will adopt a decision Detailed explanations to be annexed. CMD has the legal power MS ≠ CMD(h) ≠ PRAC MS = “No CAP concerned”

12. 12 Decision-making for PSURs, referrals, PASS Single AR prepared by the Rapporteur appointed by PRAC PRAC to adopt the AR If any regulatory action results from the AR, CHMP to adopt an opinion: maintenance, variation, suspension or revocation + according timetable for implementation Commission to adopt a decision concerning the regulatory action(s) “At least 1 CAP concerned”

13. 13 EMA Priorities EMA/MSs technical contribution to EC Implementing measures Business process mapping IT requirements supported by business process mapping Concept papers (for policy issues) Good Vigilance Practice guidelines SOPs/WINs/Templates

14. 14 Hierarchy of rules - Regulation (EU) 1235/2010 - Directive 2010/84/EU - EC Implementing measures = Commission Regulation (Reg. Art. 87a and Dir. Art. 108) - Policies - Operations - ICT Guidelines SOP/WIN/Templates IT Tools Impact on EMA and MSs

15. 15 Transparency and Communication: EU and National Medicines web-portals Dramatic increase in transparency e.g. ‘protocols and public abstracts of results as regards post authorisation safety studies’ EMA to coordinate MS safety announcements Public hearings Some Key Changes

16. 16 The Agency shall establish a list of all medicinal products authorised in the Community. To this effect the following measures shall be taken: –(a) the Agency shall…..make public a format for the electronic submission of medicinal product information –(b) MAHs shall, by 18 months after the entry into force of regulation, electronically submit to the Agency information for all medicinal products authorised or registered in the Community, using the format referred to in point (a); –(c) from the date set out in point (b), MAHs shall inform the Agency of any new or varied authorisations (…) EU Medicinal Product Dictionary

17. 17 Project Oversight Committee (ERMS-FG) Project Coordination Group EMA/MSs Project Team 1 - Audit/ Inspections EMA/MSs Project Team 2 PSURs EMA/MSs Project Team 3 ADR reporting /Additional Monitoring/ -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 12 EMA Subproject Teams PSUR PASS/PAES Product Info. EV/ADR rep. Committees Referrals Fees Com./Transp Lit. monit/ Signal detect. Insp./PhV sy. RMS PhV audits Governance – EU Network 6 EMA/MSs Subproject Teams EMA Task- Force

18. 18 (a)The content and maintenance of the pharmacovigilance system master file kept by the MAH; (b) The minimum requirements for the quality system for the performance of pharmacovigilance activities by the Agency (the NCAs and MAH); (c)The use of internationally agreed terminology, formats and standards for the performance of pharmacovigilance activities; Technical contribution to EC implementing measures Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108 What will be delivered? (1/2)

19. 19 (d) The minimum requirements for the monitoring of data included in the EV database to determine whether there are new risks or whether risks have changed; (e) The format and content of electronic transmission of suspected adverse reactions by MSs and MAHs; (f) The format and content of electronic PSURs and RMPs; (g) The format of protocols, abstracts and final study reports of the PASS; Technical contribution to EC implementing measures Reg. (EU) 1235/2010 Art. 87a and Dir. 2010/84/EU Art. 108 What will be delivered? (2/2)

20. 20 Implementation of new legislation Implementation: July 2012 Transitional provisions on: -Centralised reporting of Periodic Benefit Risk Reports to EMA -Centralised reporting to Eudravigilance Full implementation may take to 2013…..

21. 21 Major undertaking over the next 18 months (and beyond) Dedicated governance structure for the EU Regulatory Network has been put in place EMA stakeholders forum EC public consultation Most of the implementation will have to be finalised by the end of 2012 Work is currently in progress

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