Euro Roundup: EFPIA warns of ‘critical challenges’ to starting clinical trials that use IVDs

Sponsors operating in the EU face “critical challenges” when trying to set up clinical trials that require the use of an in vitro diagnostic (IVD), according to officials at EFPIA, who called on the European Commission to address the challenges to avoid damaging the local clinical trial environment.
 
In the statement, EFPIA (the European Federation of Pharmaceutical Industries and Associations) voiced its full support for the In Vitro Diagnostic Regulation (IVDR), which came into force on 26 May , but warned the EU still faces critical challenges “that may ultimately lead to a reduction of clinical trial sites in Europe” and to delayed patient access to novel therapies. The criticism centers on the perceived shortcomings of the process for reviewing filings to use IVDs in clinical trials.
 
“As of today, neither the streamlined process created by the IVDR to facilitate the review of applications for IVDs used in clinical trials nor the supportive infrastructure and the guidance needed to enable companies to evolve in a fully reliable and operational environment, are in place,” the trade group wrote.
 
Unless the Commission acts, the EU may suffer “unintended consequences” that damage the clinical trial environment, according to EFPIA, which called for the Commission to address the critical challenges and offered to “participate in a constructive dialogue” about potential solutions and guidance “that will enable the optimal use of IVDs in clinical research.”
 
EFPIA released the statement a little more than one week after the Medical Device Coordination Group (MDCG), which advises the Commission on matters related to IVDR, published a question and answer document about the interface between the new regulations on clinical trials and IVDs. The document explains how IVDR applies to diagnostics used in clinical trials with a view to supporting the coordinated assessment of filings to run multi-country studies. 
 
“The aim of this Q&A is to support these coordinated assessments by providing clarification on the regulatory status of assays performed on human samples used in the context of clinical trials as well as on the regulatory expectations toward the clinical trial sponsors. The overall aim is to support the conduct of clinical trials using diagnostic assays, including combined trials for the development of companion diagnostics,” MDCG wrote.
 
EFPIA Notice
 
Italy prepares for June launch of National Pharmacovigilance Network, data format
 
Italy is gearing up to launch a new National Pharmacovigilance Network (RNF) and international standard format for collecting data on adverse reactions on 20 June. The changes will enable a new online method for reporting adverse events to the Italian Medicines Agency (AIFA).
 
Starting 9 June, Italy is in a transitional phase in which healthcare professionals and patients will need to email details of suspected adverse reactions using the reporting forms. Affected stakeholders can either send emails to the product’s marketing authorization holder or to the pharmacovigilance officer of their facility.
 
The transitional phase will continue until 20 June, when RNF is set to go live. RNF is designed to have “advanced functions for the management and analysis of reports of suspected adverse reactions in order to ensure an increasingly accurate assessment of the safety profile of medicines.” The changes include the adoption of a new reporting method.
 
Italy’s switch to the new system will also see it replace its current Vigifarmaco portal. AIFA deactivated the portal on 8 June in preparation for the launch of reporting via its own portal. The new process will comply with a new international standardized format for reporting suspected adverse drug reactions, the use of which will become mandatory in the EU at the end of the month. Switching to the new format will enable Italy to link RNF to the EudraVigilance system to share adverse event reports.
 
AIFA Notice
 
Spain reports 160% jump in suspected adverse event reports
 
The Spanish Agency of Medicines and Medical Products (AEMPS) has reported a 160% increase in the number of notifications of suspected adverse events. COVID-19 vaccines drove the surge in activity.
 
As in the broader EU region, where the number of authorized product suspected adverse reactions rose 93% in 2021, COVID-19 vaccines account for all of the extra activity. Last year, AEMPS received 81,447 notifications of suspected adverse reactions, compared to 31,176 in 2020 and 37,479 in 2019. Excluding the 55,116 notifications related to COVID-19 vaccines, the number of suspected adverse reaction reports fell to 26,331.
 
Regulators expected the number of suspected adverse reaction reports to rise quickly in 2021 as millions of people received newly authorized COVID-19 vaccines. While managing the extra pharmacovigilance workload, AEMPS also carried out 21 national and international inspections related to the production of COVID-19 vaccines. As of April 2022, Spain had manufactured 460 million doses of mRNA vaccines.
 
Other activities related to COVID-19 declined in 2021. AEMPS saw a 73% drop in authorization requests for compassionate use last year, as well as a 10% decline in the number of actions taken to ensure the availability of medicines. The number of authorized clinical trials fell from 1,027 to 996. Almost 5% of the trials authorized last year related to COVID-19. 
 
AEMPS Notice (Spanish)
 
France updates good pharmacovigilance practices to reflect compassionate use reforms
 
France’s National Agency for Medicines and Health Products Safety (ANSM) has updated its good pharmacovigilance practices (GVP) for the first time since 2018 to reflect  developments including the reform of the compassionate use process.
 
New rules on access to unauthorized medicines by patients with serious, rare or debilitating diseases came into force in France last summer. The changes, which are intended to simplify and accelerate the process, have factored into the revision of ANSM’s GVPs. ANSM’s GVP document groups compassionate use products with medicines granted early access authorization.
 
The updated GVPs feature other changes relating to the reporting and processing of medication errors and the role marketing authorization holders play in the pharmacovigilance process in France.
 
ANSM Notice (French)
 
UK MHRA rejoins ICH Assembly after Brexit-triggered split from the EU delegation
 
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has rejoined the International Council for Harmonisation (ICH) Assembly as a member, giving it a full say in the activities of the organization for the first time since Brexit.
 
Before Brexit, MHRA participated in ICH activities as part of the EU delegation, enabling it to sit on working groups and influence international standards. Leaving the EU forced the UK to reapply, initially as an observer. ICH admitted the UK regulator as an observer last summer. Traditionally, observers have needed to attend three out of four consecutive biannual ICH meetings to achieve full membership.
 
ICH adopted an expedited process for regulatory authorities that have implemented at least 75% of its guidelines in 2020, offering MHRA a shorter path to membership. MHRA has now completed the process, leading ICH to accept the agency as a new member. The change allows MHRA to resume contributing to and voting on ICH activities.
 
ICH Notice
 
Other news:
 
The Finnish Medicines Agency (Fimea) is seeking feedback on an evaluation of Astellas Pharma’s Padcev in advanced urothelial cancer. Fimea Notice (Finnish)