The implementation of the new EudraVigilance system requires the migration of more than 11 million cases from the current database, which will be completed from 08 to 21-Nov-2017 when some functionalities of the system will be unavailable. The electronic submissions of data on medicines (Article 57) will be unavailable whereas the electronic reporting of ICSRs by National Competent Authorities (NCAs), Marketing Authorisation Holders (MAHs) and Sponsors of Clinical Trials (Sponsors) will be disrupted.
The go-live plan published by the EMA
describes the alternative reporting arrangements during the cutover period, and
three options are presented separately for Clinical Trial SUSARs and
Post-marketing ICSRs:
- Option 1: The submission is stopped. This applies to EudraVigilance but also to a list of NCAs, some of which will stop sending/receiving cases as early as 04-Nov-2017.
- Option 2: The MAH/Sponsor has to follow alternative arrangements (e.g. fax or email) for submission to NCAs during the cutover period.
- Option 3: No change to current arrangements. The MAH/Sponsor continues with the electronic submission of NCAs, which applies in the UK (MHRA) and Germany (BfArM and PEI). Specifically for SUSARs, Option 3 also applies to NCAs that do not currently accept E2B reports (e.g. France) and Sponsors should continue with the current reporting method (e.g. email or web portal).
Following the launch of the new EudraVigilance system on 22-Nov-2017, all reports that could not be submitted electronically during the cutover period will need to be submitted within 2 EMA business days following the go-live of EudraVigilance, i.e. by 24-Nov-2017.
Regarding Post-Marketing ICSRs routinely
sent by NCAs to MAHs, the MAHs will need to use EVWEB functionalities to
download the reports submitted by NCAs to EudraVigilance and the corresponding
ICSRs will be available for download as of 23-Nov-2017.
The Medical literature monitoring (MLM) by
the EMA will continue during the cutover period but the screening results will
only become available to MAHs in the restricted area of EudraVigilance on
22-Nov-2017. The resulting valid cases will be entered from 20 to 30-Nov-2017
and the corresponding ICSRs will again start to become available for download
by MAHs as of 23-Nov-2017.
In
addition to the go-live plan, the EMA has published a short Technical Note that
describes the impact of the planned downtime on other IT systems and provides
corresponding instructions. This concerns for example submission to the PSUR
Repository and EudraCT database.
Thierry Hamard is a Pharmacist with more than 12
years of Global Pharmacovigilance Auditing experience and over 200 PV Audits
performed since his company PV Focus was established in 2004.
Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.
Thierry is also Chief Editor of Safety Observer, a provider of Regulatory Intelligence services for Pharmacovigilance since 2005.
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