Other News

Key pharmacovigilance trends to watch

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:

  • more effective safety monitoring of authorised medicines
  • better support for signal detection and evaluation of potential safety issues
  • more data made available for research
  • better information on suspected adverse reactions for healthcare professionals and patients

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

Please let us know any comments you have on this article:

Also see our

press coverage

News Index

11 Feb 2019

Garth Hedenskog joins ELC Group to expand global sales

26 Nov 2018

Industry plans for disruption amid Brexit uncertainty

25 Oct 2018

ELC Group at 5th Nordic Pharmacovigilance Day - Oct 24th, Copenhagen

05 Oct 2018

EU/US MRA - Brief overview and update

21 Aug 2018

Brexit - has the music stopped?

13 Jul 2018

Recent EMA Brexit Survey

15 Jun 2018

The EMA: 100 not out

08 May 2018

MHRA sets its post-Brexit strategic direction

12 Apr 2018

Brexit - Stick or Twist?

20 Mar 2018

Clinical Trials: all change 2019

22 Jan 2018

Orphan Medicines: almost 20 years on

15 Dec 2017

Update on Brexit developments

05 Oct 2017

How recent moves by the FDA spell good news for generics in the US

11 Sep 2017

Medicines for the Elderly – is your drug development strategy up to the mark?

14 Aug 2017

The MNAT initiative – what’s new?

19 Jul 2017

ICH Q12: Light at the end of the tunnel…?

05 Jun 2017

Q3D: Are your established products in compliance?

02 Jun 2017

Key pharmacovigilance trends to watch

08 May 2017

EMA updates guidance on PSURs

10 Apr 2017

New EMA Consultation on the Quality of Inhaled Pharmaceutical Products

16 Mar 2017

European Parliament’s adoption of ‘Options for improving access to medicines’ procedure

16 Feb 2017

Article 58: a hidden potential

24 Jan 2017

Global lifesciences partner ELC Group teams with PSR Group for advanced drug development

19 Jan 2017

A positive step forward for Biosimilar registration

20 Dec 2016

Falsified Medicines Directive – Are you making the right preparations?

21 Nov 2016

New Public consultation launched by the European Commission (EC)

19 Oct 2016

Transatlantic collaboration to boost research and development of medicines for rare diseases

03 Jun 2016

ELC Group to showcase regulatory affairs solutions at CPhI events in Shanghai and Barcelona

16 Jun 2015

ELC Group in early-stage development of novel influenza vaccine

09 Jun 2015

ELC Group expands into pharmaceutical product development market

21 Apr 2015

ELC Group signs 1.5 million Euro regulatory affairs contract with Chinese pharma giant

24 Feb 2015

Fast-growing regulatory affairs service provider ELC Group expands corporate presence in Czech Republic

02 Feb 2015

ELC GROUP to present at “Regulatory & Legal Affairs in Russia 2015” Conference

15 Sep 2014

Pharma eReport delivers V5-compliant solution to help MAHs meet December 31st XEVMPD resubmission deadline

20 Aug 2014

ELC Group Appoints Dr. Siddharth Chachad as Head of Global Clinical Development and Medical Affairs

28 Jul 2014

ELC Group Appoints Head of Regulatory Affairs for Russia and CIS

14 Apr 2014

Global regulatory affairs specialist ELC Group appoints Localization Business Development Manager for new US Office

10 Oct 2013

Global regulatory affairs specialist ELC Group accelerates international expansion plans following 25% revenue growth in 2013

17 Sep 2013

Global regulatory affairs specialist ELC Group appoints former MHRA Expert Medical Assessor

23 Apr 2013

Global regulatory affairs specialist ELC Group receives accreditation to provide readability testing in Romania

27 Feb 2013

Global regulatory affairs specialist ELC Group to deliver pharmaceutical training event in Latvia

20 Feb 2013

Global pharmaceutical regulatory affairs specialist ELC Group launches Clinical Trials services

10 Jan 2013

Global pharmaceutical regulatory affairs specialist ELC Group hosts International Training Seminar in Mumbai, India

31 Dec 2012

2012 Events

07 Nov 2012

Global pharmaceutical regulatory affairs specialist ELC Group establishes new office in Singapore

22 Aug 2012

Global pharmaceutical regulatory affairs specialist ELC Group increases operational support in Ahmedabad

12 Jun 2012

XEVMPD software provider Pharma eReport launches Excel Data Import Service

06 Jun 2012

ELC Group partners with mdi Europa GmbH to offer end-to-end regulatory solution for medical device companies in Europe

28 Mar 2012

ELC Group joins DIA EuroMeeting in Copenhagen

21 Mar 2012

EVMPD software provider Pharma eReport announces full general availability of Centrality XEVMPD compliance solution

08 Mar 2012

ELC Group Hosts Successful International Regulatory Seminar

06 Mar 2012

Pharmaceutical regulatory affairs specialist ELC Group opens new office in Mumbai

23 Feb 2012

Regulatory challenges for 2012 and their impact on marketing authorisation

21 Feb 2012

ELC Group launches new software subsidiary Pharma eReport to provide complete EVMPD compliance solution

08 Feb 2012

Pharmaceutical regulatory affairs specialist ELC Group establishes global HQ in Cambridge, UK

07 Dec 2011

Past president of TOPRA and ELC GROUP Advisor speaks at International Regulatory Seminar in Ahmedabad 23 February 2012

27 Sep 2011

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

12 Jul 2011

ELC Group aim to foster strategic and economic ties within India and China

25 May 2011

ELC Group announces doubled revenues

11 May 2011

ELC Group appoints former TOPRA President