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Building on Drug Safety - the new EU guidelines May 2012
1.
Safeguarding public health Building
on drug safety: How new EU regulations are changing pharmacovigilance Claire Tilstone May 2012 ©
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 Slide 2 ©
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 Slide 3 ©
4.
Key areas • Audit
and inspection • Adverse drug reaction (ADR) reporting and signal management • Risk minimisation • Committees and referrals • Communications and transparency Slide 4 ©
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 Slide 5 ©
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 Slide 6 ©
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 Slide 7 ©
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 Slide 8 ©
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 Slide 9 ©
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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