Update ICSR Reporting. EudraVigilance Reporting Getting ready for E2B (R3) Disclaimer:

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1 Update ICSR Reporting Dr. Waltraud Trabe / Mag. Katharina Weber Austrian Federal Office forsafety in Healthcare Institute of Surveillance Dep. BTVI (Blood, Tissue & Vigilance) Traisengasse5, 1020 Vienna Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH Disclaimer: The views expressed in this presentation are personal ones and may not be understood or quoted as being made on behalf of or reflecting the position of the Austrian Competent Authority or European Medicines Agency. This presentation partly builds on materials published by the European Medicines Agency. 2 EudraVigilance Reporting 3 1

2 Published Technical Documentation: ICH Documentation ( ICH Implementation guide package ICH E2B(R3) Questions & Answers ( Products/Guidelines/Efficacy/E2B/E2BR3_Q_As.pdf) EU Documentation ( EU Individual Case Safety Report (ICSR) Implementation Guide 4 EVWEB will only produce R3 messages Access to data in EV will only be provided in R3 format By July 2016 MAHs and NCAs should be able to accept E2B(R3) messages MAHs / NCAs have to perform a test period with EMA (no testing with NCAs) 5 What to do (1): MAH/Sponsor contacts EMA to book testing timeslot EMA confirms timeslot & sends batch of test cases to MAH/Sponsor MAH/Sponsor imports cases into database & transmits to EV EV returns ACK MAH/Sponsor check ACKs Unless MAH/Sponsor database has introduced errors, ACKs will be

3 What to do (2): EMA checks cases, replies to MAH/Sponsor with findings Unless MAH/Sponsor database has introduced errors, cases will all be fine MAH/Sponsor checks schema and corrects errors Repeat cycle until there are no more errors 7 Testing will be performed in pre-booked timeslots of 1 week EMA will maintain a calendar with timeslot availability to ensure that sufficient time can be dedicated to all agreed tests in a given week All slots will be booked on a first-come first-served basis MAHs should ensure that they have transmitted their cases and received 01 ACKs before their testing week 8 Medical Literature Monitoring Service 9 3

4 Legal Background (1) Article 27 of Regulation (EC) 726/2004: 1. The Agency shall monitor selected medical literature for reports of suspected adverse reactions to medicinal products containing certain active substances. It shall publish the list of active substances being monitored and the medical literature subject to this monitoring. 2. The Agency shall enter into the Eudravigilance database relevant information from the selected medical literature. 3. The Agency shall, in consultation with the Commission, Member States and interested parties, draw up a detailed guide regarding the monitoring of medical literature and the entry of relevant information into the Eudravigilance database. Article 107(3) of Directive 2001/83/EC: For medicinal products containing the active substances referred to in the list of publications monitored by the Agency pursuant to Article 27 of Regulation (EC) No 726/2004, marketing authorisation holders shall not be required to report to the Eudravigilance database the suspected adverse reactions recorded in the listed medical literature, but they shall monitor all other medical literature and report any suspected adverse reactions. 10 Legal Background (2) AMG 75j (4) Bei Arzneispezialitäten mit Wirkstoffen, auf die sich die Liste von Veröffentlichungen bezieht, die die Agentur gemäß Art. 27 der Verordnung (EG) Nr. 726/2004 überwacht, sind die Zulassungsinhaber nicht verpflichtet, die vermuteten Nebenwirkungen, die in der in der Liste angeführten medizinischen Fachliteratur verzeichnet sind, an die Eudravigilanz-Datenbank zu übermitteln. > National implementation in other EU countries?? 11 Timetable EMA Testing of new EV functionalities (MAH/NCA volunteers) May Launch of website & comm. Q&A sessions Contractor set-up phase Launch preparation Q&A sessions July launch of service (50 top substances) Stakeholder support Launch of service full scope (400 substance groups) Stakeholder support April June September as published by EMA 12 4

5 Status Quo service is fully operational (400 substance groups) as of 1 September Read more at EMA website: neral_content_ jsp The lists of substance and herbal-substance groups which are subject to EMA s monitoring activities are published on the above website (MS Excel format). In addition, a Q&A document has been made available by EMA ( C pdf) 13 How it works (1) ICSRs resulting from the service refer to the selected medical literature that is monitored by EMA (medicinal products containing active substances identified as part of the scope of EMA s activities). MAHs still need to perform literature search beyond the service provided by EMA, as defined in GVP Module VI.B (e.g. local journals, conferences etc..). ICSRs resulting from the service are transmitted electronically via the EudraVigilance Gateway to NCAs in EEA Member States in accordance with the reporting requirements of ICSRs applicable during the interim period. ICSRs resulting from the service are transmitted electronically to EudraVigilance. 14 How it works (2) ICSRs resulting from the service are made available for download by the MAHs concerned (EudraVigilance download area or EVWEB). This refers to ICSRs of suspected serious adverse reactions occurring within and outside the EEA and non-serious adverse reactions from within the EEA. Concerned MAHs can download the ICSRs resulting from the service in XML format in compliance with the Note for guidance: EudraVigilance Human Processing of safety messages and individual case safety reports (ICSRs) (EMA/H/20665/04/Final Rev. 2). MAHs to send follow-ups to NCA only in relevant cases (e.g. significant update of medical information if available). 15 5

6 Follow-up process When significant follow-up information on an existing report is available to MAH/NCA, a follow-up report based on the original case should be created and reported by the MAH/NCA. Original report and follow-up report (sent by MAH/NCA) will then be merged by EMA (time delay of appr. 1 calendar day), and the updated case will then be sent to EudraVigilance (available for download). Read more: C pdf 16 What not to do NCAs in EEA Member States should not forward/provide the ICSRs resulting from the service to the concerned MAHs, since MAHs can download those ICSRs from the EudraVigilance Download Area. Concerned MAHs should not re-submit the ICSRs resulting from the service to EudraVigilance. Unless otherwise specified by national legislation and guidance, concerned MAHs should not submit ICSRs resulting from the medical literature monitoring service to the concerned NCA in the EEA. 17 CAVE EMA provides the service of identifying literature reports and entering them into EV. This service relieves the concerned MAH from their reporting obligation, but not from the obligation to identify (download) reports and process them within their PV system in time (e.g. for signal management). Further developments: EMA in future to do one round of follow-up attempts according to pre-defined parameters (not yet published). This future service does not relieve the concerned MAHs to do further follow-up as appropriate (e.g. as defined within own risk management system). 18 6

7 Duplicate Detection 19 Duplicate Detection The majority of duplicates is identified in relation to lack of patient / primary source data GVP Module VI "VI.C What to take into account for data privacy laws Submitting patient/reporter data to an EU NCA or EMA is not a data privacy violation! Consider: Impact on signal detection! 20 Questions? pharm-vigilanz@ages.at lob_und_tadel@ages.at 21 7