This document discusses new EU regulations that are changing how drug safety is monitored. Key changes include centralized adverse drug reaction reporting, required risk management plans for new drugs, and a new risk assessment committee. The regulations aim to take a more proactive, proportional, and transparent approach to pharmacovigilance to better protect public health. National authorities and the EMA will provide information on company drug safety systems, adverse events, risk minimization plans, and committee decisions.

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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