Claire Tilstone - MHRA

1. Safeguarding public health
Building on drug safety:
How new EU regulations are
changing pharmacovigilance
Claire Tilstone
May 2012
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2. 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:
9. Proportionality; risk-based approach
10. Risks considered in the context of benefits
11. Considering outcomes and effectiveness of regulation
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3. 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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4. 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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5. Audit and inspection
Requirements 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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6. 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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7. Risk minimisation
• Focus: forward-planning; dynamic; proportionate;
transparent; auditable
• Risk management plans required for all new marketing
authorisations (MAs) from July 2012 (modular structure)
• Post-authorisation safety/efficacy studies may be a new
obligation (condition) on or after granting an MA
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8. 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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9. 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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10. 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=WC0b01ac0580
04d5c1&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=WC0b01ac0580
04d5c1&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=WC0b01ac0580
04d5c1]&jsenabled=true
Email: p-pv-helpdesk@ema.europa.eu Slide 10
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