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Safeguarding public health

Building on drug safety: How new EU regulations are changing pharmacovigilance

Claire TilstoneMay 2012

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London 2012

European Medicines Agency (EMA) and MHRA ushering in a new era in drug safety• Building on principles in volume 9A• Regulation (EU) No1235/2010• Directive 2010/84/EU (to be transposed into UK Human

Medicines Regulation 2012)• Underpinned by a series of Implementing Measures and

Transitional Arrangements

Key principles:1. Proportionality; risk-based approach2. Risks considered in the context of benefits3. Considering outcomes and effectiveness of regulation

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Good pharmacovigilance practice

New guidelines for conduct of pharmacovigilance in EU are outlines in Good Pharmacovigilance Practice (GVP) modules

Wave I topics recently subject to public consultation:

• I. Pharmacovigilance systems and their quality systems• II. Pharmacovigilance system master file• V. Risk management systems• VI. Management and reporting of adverse reactions• VII. Periodic Safety Update Report• VIII. Post-authorisation safety studies• IX. Signal management

Further waves due to be published in 2012 covering topics such as communications and audit

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Key areas

• Audit and inspection

• Adverse drug reaction (ADR) reporting and signal management

• Risk minimisation

• Committees and referrals

• Communications and transparency

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Audit and inspectionRequirements for information provided to Member States and EMA about pharmacovigilance system(s) of marketing authorisation holders (MAHs) change in several ways:

• Summary information only on EU qualified person for pharmacovigilance (QPPV) and location of a pharmacovigilance system master file (PSMF) will be contained in marketing authorisations

• Full descriptive information about pharmacovigilance systems will have to be contained in PSMF, available to Competent Authorities on request)

• Detailed requirements for PSMF concern its availability, structure, content and maintenance

• PSMF will encompass pharmacovigilance system and may relate to one or more products; content changes not automatically notifiable to Competent Authorities

• Differs from current Detailed Description of the Pharmacovigilance system (DDPS), which will be phased out from July 2012–15

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ADR reporting and signal management

• Patients included as valid reporters of ADRs• Definition of ADR extended to include harm from “noxious and unintended” reaction: ie, error, misuse, abuse, off-label• Centralised reporting to Eudravigilance (likely 2015)• EU-wide list of products subject to additional monitoring (to include biosimilars and biologicals); phasing out of UK Black Triangle Scheme

• PSURs: cumulative benefit-risk evaluation of signals• Rationalisation via: modular structure; waivers; risk-based

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Risk minimisation

• Focus: forward-planning; dynamic; proportionate; transparent; auditable

• Risk management plans Risk management plans required for all new marketing authorisations (MAs) from July 2012 (modular structure)

• Post-authorisation safety/efficacy studies Post-authorisation safety/efficacy studies may be a new obligation (condition) on or after granting an MA

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Committees and referrals

• There will be a new EU committee: the Pharmacovigilance Risk Assessment Committee (PRAC) to advise current CHMP and CMDh committees

• New oversight in relation to risk minimisation via assessment of PSURs, RMP, PASS

• Role also in referrals; transitional arrangements will outline how legislation affects trigger date

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Communications and transparency

• Role of MAHs: timely and objective notifications• National web portals to host range of transparency documents:

- SPCs and PILs- Summaries of Risk Management Plans- Public Assessment Reports (including conditions)- Products under additional monitoring- ADR reporting forms

• EMA web portal expected to host further information relating to:

- PASS abstracts, protocols and study reports- Committee details

• There will be EU public hearings on drug safety

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Further information and links

• MHRA: http://www.mhra.gov.uk/Howweregulate/Medicines/Pharmacovigilancelegislation/index.htm

Email: pv2012@mhra.gsi.gov.uk

• EMA:- Regulation: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF - Directive: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF - Draft Implementing Measures: http://ec.europa.eu/enterprise/tbt/tbt_repository/EU29_EN_1_1.pdf - Transitional arrangements: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001450.jsp&mid=WC0b01ac058004d5c1&jsenabled=true - GVP modules:http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/02/news_detail_001451.jsp&mid=WC0b01ac058004d5c1&jsenabled=true - Union Reference Date list on PSUR periodicity consultation:http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/03/news_detail_001479.jsp&mid=WC0b01ac058004d5c1]&jsenabled=true

Email: p-pv-helpdesk@ema.europa.eu