Pharm acovigilance legislation: Our im plem entation journey… Training session on the new pharmaceutical legislation, European Medicines Agency 29 November 2012 Franck Diafouka, Project Manager, Pharmacovigilance and Risk Management, An agency of the European Union Patient Health Protection, EMA
Content • Our implementation journey: where are we? • Our implementation journey: where are we going? • Conclusion 1
I m plem entation journey…. PHARMACOVIGILANCE I m plem enting Fees RoP regulation EU m edicines w eb-portal Public Agendas hearings PSUR Pharm aco Minutes -vigilance Good system s PASS Lists pharm acoVigilance Fees practice ( GVP) EC Article ADR decision PAES RMP Renew al 5 7 reporting PRAC Mandate Mem ber PASS I nspections Signals EMCDDA States W eb form s CHMP Pharm acovigilance Literature audits m onitoring Additional Safety m onitoring EudraVigilance announ- Coordination Group EURD list cem ents Black PRAC Lists PRAC sym bol recom m en Drug abuse advice -dation Signal Medication Public health Referrals PRAC detection errors EMA 2
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting Technical regulation ( EU) Contribution (June 2011) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Guidance Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business Questions and Answers documents processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business Questions and Answers documents processes Working agreement I nform ation and Com m unication Tools
W orking agreem ent to enhance cooperation w ith EMCDDA* • Article 28c(2): ‘The Agency and the EMCDDA shall exchange information that they receive on the abuse of medicinal products including information related to illicit drugs’. • Working arrangement (first signed in 2010) amended by EMA and EMCDDA Directors to strengthen information-exchange practices. • More timely response to potential public health threats * EMCDDA: European Monitoring Centre for Drugs and Drug Addiction 10
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business Questions and Answers documents processes Working agreement Rules of Procedure and Mandates I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business Questions and Answers documents processes Working agreement Rules of Procedure and Mandates I nform ation and Products-related lists Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Reflection papers Policy and Good pharmaco- Guidance Vigilance Practice Guidance documents Business Questions and Answers documents processes Working agreement Rules of Procedure and Mandates I nform ation and Products-related lists Com m unication Tools Pharmacovigilance training
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Detailed Business Process Mapping Business processes I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Detailed Business Process Mapping Business Committees/ decision processes -making I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes Templates I nform ation and Com m unication Tools
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes Templates I nform ation and Format for electronic Com m unication Tools submission of product information
Key achievem ents Regulation ( EC) 7 2 6 / 2 0 0 4 and Directive 2 0 0 1 / 8 3 / EC EC im plem enting regulation ( EU) No 5 2 0 / 2 0 1 2 Policy and Guidance Business processes Templates I nform ation and Format for electronic Com m unication Tools submission of product information EMA Corporate website
EMA Corporate w ebsite • Legal notice: EMA website will serve as the EU Medicines Web- portal • Upgrade of EMA corporate website – New page for general public on pharmacovigilance implementation, including ‘video’. – Updated template for safety referrals – New search function for all referrals, – New page for industry on pharmacovigilance implementation • Publication of plan for prioritised implementation 19
Prioritised im plem entation agreed by EMA Managem ent Board in Decem ber 2 0 1 1 20
Prioritised im plem entation agreed by EMA Managem ent Board in Decem ber 2 0 1 1 • Criteria for prioritisation: – Firstly, public health activities – Secondly, transparency and communication activities – Thirdly, simplification activities (primarily for pharmaceutical industry) • Activities grouped into four m ain topic areas: – Collection of key information on medicines – Better analysis and understanding of data and information – Regulatory action to safeguard public health – Communication with stakeholders • Traffic light: Not started On-going im plem entation 21 I m plem ented
I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 : Collection of key inform ation on m edicines ( 1 / 2 ) 1 . Risk Managem ent Plans: ● Started July 2012 Establishment and operation of new ● Templates for industry (Oct) procedure for requesting and assessing ● Format compulsory (Jan 2013) RMP 2 . Periodic Safety Update Reports: ● Started July 2012 Operation of new procedures related to PSURs for CAPs ● First list published in Oct 2012 Development and publication of harmonised birthdates to support PSUR (monthly update) submission 22
I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 : Collection of key inform ation on m edicines ( 2 / 2 ) 3 . Post-Authorisation Safety and Efficacy Studies: ● Started July 2012 Implementation of the PASS procedure for protocols approval and results management for CAPs ● Awaited Consultation on scientific guidance for PAES 4 . Electronic subm ission of core m edicine inform ation by MAHs ( ‘Article 5 7 ’) : ● Joint implementation group Start validation of received information (Oct 2012) 5 . Reporting by patients: ● Core data fields agreed by Cooperation with Member States to provide information to patients on direct reporting Member States (June 2012) 23
I m plem entation of the pharm acovigilance legislation by the EMA in 2 0 1 2 : Better analysis/ understanding of data and inform ation ( 1 / 2 ) 1 . EudraVigilance and signal detection ● Started July 2012 Operation of revised signal detection process for CAPs ● Started July 2012 Support Member States to operate the new ● Signal work-sharing list EU signal detection processes for NAPs published (Oct 2012) ● Started Sept 2012 Start of signal management through the Pharmacovigilance and Risk Assessment Committee (PRAC) ● As planned Continuation of maintenance work for the current EV system including data quality ● Delivered in May 2012 Implementation of web-publishing of adverse reaction data (further to the EV Access Policy) 24
Recommend
More recommend
