The regulatory outlook: Detailing some of the challenges the industry will face

25 October 2017

12:00

With the forthcoming regulatory changes set to come into force over the next couple of years in pharma, management practices will surely be tested. In this article, Tom Nichols, senior director, Pharmacovigilance at Quanticate, details some of the challenges the industry will face.

Outlook

Since the introduction in 2012 of good pharmacovigilance practices (GVPs) in the European Union (EU), the industry has experienced rapid changes and it is showing no sign of slowing. The next two years are looking to be no exception, with 2019 scheduled to be a year that will really test companies’ change management practices.

Eudravigilance launch and GVP revisions

Tom Nichols, senior director, Pharmacovigilance at Quanticate

Tom Nichols

On 22 November 2017, we will see the launch of not only the new EudraVigilance system¹ but also the updated GVP Module² VI that covers the collection, management and submission of reports on suspected adverse reactions to medicinal products. Standard operating procedures (SOPs) and best working practices must therefore be fully reviewed to ensure they address all aspects of new functionality of EudraVigilance but also the practical issues resulting from changes to data collection requirements, not least the need to receive cases electronically in the new E2B(R3) format.

The increase in data fields in E2B(R3) expected in Individual Case Safety Reports (ICSRs) will require comprehensive retraining of staff and potentially increased resourcing for departments, due to the prolonged processing time of these cases.

For larger companies, where separate teams may deal with EudraVigilance and case processing, cross-functional working groups must be formed to ensure that decisions are being made centrally. For smaller companies, challenges lie in the perceived scale of the changes to be adopted and with such time constraints too. To assist the industry as it continues to respond to these regulatory changes, the European Medicines Agency (EMA) has provided guidance with a EudraVigilance stakeholder change management plan.

The updated GVP Module IX (signal management), another major GVP revision, links to the new EudraVigilance system and is also due to come into effect in 2019.

The EudraVigilance Data Analysis System (EVDAS)³ will allow marketing authorisation holders (MAHs) to view reports on their active substances to aid and enhance signal detection activities. Again, this will require coordination between groups overseeing EudraVigilance and those responsible for signal detection activities within a company. Most pressingly, the EMA has published a list of timeslots for companies to register for the system and failure to meet the assigned slot may lead to significant delays, which would have subsequent knock-on effects to managing the change control process.

Clinical trial regulation

The 2014 Clinical Trial Regulation (CTR) (Eu No. 536/2014) was scheduled to be introduced in 2018.⁴ However, delays in confirming the functionality of the EU portal and database means that this is now expected to be introduced in 2019. Application of the regulation will be six-months after the functionality of portal and database are confirmed via an independent audit. In isolation, PV in the new CTR is not particularly different from the existing requirements, but this does not mean that PV departments do not need to react.

Once again, cross-functional teams will be needed to ensure changes in working practices all continue to remain cohesive. This may be particularly relevant where PV departments deal with both clinical and post-marketing responsibilities and have many processes. Any necessary divergence in these needs to be identified and addressed, potentially leading to a much more split system.

IDMP standards

Tied in with the E2B(R3) data standards, are the Identification of Medicinal Products (IDMP) standards.⁵ The objective of this is to standardise and support identification of medicinal products in all International Conference on Harmonisation (ICH) regions. It is based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organisation and referential (SPOR) data. This has huge implications for ICSRs in both clinical and post-marketing settings, case evaluation and signal detection. SPOR data also applies to both human and veterinary products.

The SPOR project will call for transition from the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) and the Article 57 database. Once this transition has been finalised, E2B(R3) reporting in the EU will also become fully mandatory.

Therefore, companies need to remain ahead of the curve on E2B(R3) compliance and adopt new systems as early as possible, so that both major changes are not being introduced simultaneously. If companies are not ready with compliant databases and processes from day one of the new Eudravigilance database in November 2017, they will need to move from temporary solutions to a more robust solution.

Brexit

The biggest shadow hanging over PV in the EU in 2019, however is Brexit. As it stands, from 30 March 2019, the UK will no longer be a part of the EU and the EMA is currently working on the assumption that the UK will become a third country. Although there is a long way to go with the Brexit negotiations, there is very little time to prepare for what the pharmaceutical industry post-Brexit will look like. As such, companies and sponsors should carefully monitor any output from the EMA on the progress of its working groups and the direction of discussions.

Unlike the other changes discussed, which are focussed very much on changes in processes of departments, Brexit will affect companies and sponsors at a wider business level. Boardroom discussions will likely be dominated by where companies and staff should be based and the economic outlook. Therefore, it is down to PV departments to be proactive in not only planning for the necessary changes, but to also make sure they are not lost within company decision-making processes.

Busy time ahead

As discussed, the next two years are expected to be an incredibly busy time with many changes for PV in the EU, culminating in a surge in activity expected in 2019. Some of the changes, such as E2B(R3) are clearly defined and can be addressed immediately, allowing for a smoother transition.

The industry will no doubt experience a challenging time ahead that will test both technical expertise and the ability to deal with change, but ultimately this period will lead to a stronger and more harmonised PV system within the EU.

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