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The pharmacovigilance space continues to evolve at a rapid pace, with the emergence of new technologies, increased data sources, and changing global regulatory requirements adding to the pressures and responsibilities for pharmacovigilance professionals. In this article, we explore three key issues that are impacting pharmacovigilance practice:
1. Access to EudraVigilance data – EudraVigilance Data Analysis System
The EudraVigilance access policy is based on a proactive approach to disclosing information held in the EudraVigilance database. This delivers several benefits, most notably:
A revised policy will enter into force when the new EudraVigilance system goes live on 22 November 2017. One of the new requirements will be changes to way pharmaceutical companies manage signal detection and signal validation. The evaluation of safety signals is part of routine pharmacovigilance and is essential to ensuring that regulatory authorities have the most up-to-date information on a medicine’s benefits and risks.
The updated European Union pharmacovigilance legislation brought about significant changes to electronic reporting requirements for suspected adverse reactions, to support better safety monitoring for medicines and a more efficient system for stakeholders. At present, signal detection analysis is managed independently by pharmaceutical and life science companies within their own databases, based on statistical evaluation algorithms. In December 2016, the European Medicines Agency (EMA) published guidance on routine signal detection methods in EudraVigilance for use by the agency, national competent authorities, and marketing authorisation holders. From November 2017, all marketing authorisation holders will be required to register for the EudraVigilance Data Analysis System (EVDAS) – an enhanced signal-detection and data-analysis tool to support safety monitoring directly by marketing authorisation holders. EVDAS user registration will start on 1 June 2017 in a phased approach. For further instructions please refer to the dedicated webpage.
EudraVigilance: how to register. MAHs will be required to perform their signal detection analysis within the EMA-hosted environment, based on their own data that has been previously reported to the EMA, performing signal detection and validation in line with revision 1 of GVP Module IX and the new EVDAS reports and data outputs. Marketing authorisation holders, the national competent authorities and agencies are expected to ensure continuous monitoring of the EudraVigilance database. A two weeks’ interval between reviews of EudraVigilance data is recommended for active substances contained in medicinal products included in the additional monitoring list, and it is recommended that the interval between reviews of EudraVigilance data should not exceed 6 months.
This is a significant change and overhead for companies in terms of managing signal detection. For smaller companies this will be especially challenging, since they have less data and fewer administrative resources, and many organisations may benefit from expert help to harness statistical algorithms for signal detection, validation and evaluation, plus assistance with label updates and reviews for any identified and potential signals.
2. Remote audits
Pharmacovigilance audits and inspections are a cornerstone of standard PV best practice, as outlined by the EMA, FDA, MHRA and many other global regulatory agencies. Companies should regularly perform audits internally, and on partners, vendors and other relevant parties in the PV activities. With pharmacovigilance department resources evermore stretched, however, the viability of conducting pharmacovigilance system audits remotely – maintaining effective oversight while managing resources more effectively – is increasingly becoming a consideration.
Risk-based auditing enables companies to categorise and plan for 2-3 years’ audit schedule. The benefit of remote PV audits is a reduced need for costly and time-consuming on-site visits to mid- and low-risk partners and vendors. Typically, a list of qualifying questions can be submitted to a partner or vendor and, based on the responses, a risk score is given and the audit frequency decided. If remote auditing is indicated as practical and appropriate, this can be managed by phone, video conference, via email or via the web, with remote access arranged to retrieve key documentation. With good organisation and planning, virtual inspections can greatly simplify the auditing process and could well become an increasingly attractive option for companies of all sizes.
3. Brexit and beyond
With Article 50 now invoked by the UK government, the UK has a firm timetable for Brexit and is due to leave the European Union at the end of March 2019. Since negotiations have yet to get formally underway, the shape of the final deal between the UK and the EU may not be clear for some time, but it is a reasonable expectation that, from the perspective of the EMA and the pharmaceutical industry, more clarity should be available from March 2018, to enable the global industry to adapt and plan for any change in processes. After Brexit, the UK will become a “third country”, meaning that new medicines will have separate approvals in Europe and the UK, potentially resulting in delays in new product introductions into the UK market. To reduce the impact of these changes will be the goal of all parties as the negotiations proceed and as the final settlement and separation moves closer to completion.
To this end, on May 2nd 2017, the EMA issued a notice to Marketing Authorisation Holders of centrally authorised products, alerting MAHs to some of the legal repercussions to be considered in preparation for the UK’s formal exit from the European Union.
EU law requires that MAHs are established in the EU (or EEA). So, if a company’s current EU office is in the UK, by the end of March 2019, this office would no longer be considered to be within the EU. Post-Brexit, therefore, a company may need to relocate to an EU member state, transferring the MA to the new MAH. Moreover, some activities must be performed in the EU (or EEA), related, for example, to pharmacovigilance, batch release and so on. If a MAH has a UK-based Batch Release or Batch Testing site for a product marketed in the EU, by the end of March 2019, the MAH would need to elect EU-based sites to prevent interruption of supply. Once established, the MAH would need to file Variations for each MA to change the site, as well as meet the requirements of the Health Authority in order for the Variation to be approved. In the event that a MAH has a UK-based EU Qualified Person for Pharmacovigilance (QPPV) or has a UK-based Pharmacovigilance System, the MAH would need to move these activities to the EU in order for the Pharmacovigilance of a product to be maintained.
From a pharmacovigilance perspective, it can be seen that the impact of Brexit may not be trivial, and could require significant changes at an organisational level in order to maintain regulatory compliance and ensure continued patient safety. Indeed, following a recent meeting convened to discuss pharmacovigilance post-Brexit, the Drug Safety Research Unit issued a statement, asserting that: “There is an enthusiasm to maintain much of the status quo, but the degree to which may be possible post-Brexit is not clear. Once the UK leaves the EU, it is essential that continued collaboration between the UK and Europe in pharmacovigilance is maintained and indeed enhanced.” With so much unclear at this early stage, pharmacovigilance professionals will be watching closely as negotiations progress. In terms of the ultimate likely impact of Brexit, it’s still very much a question of “watch this space”.
ELC Group’s concept to safety solution ensures tailored compliance to meet companies’ medical information and pharmacovigilance needs. We offer a complete range of services, from handling basic medical inquiries to complex adverse event intake, case processing and aggregate reporting. For more information about ELC Group’s EMA, FDA and ICH-compliant pharmacovigilance solutions, please visit: en/Pharmacovigilance.