Sponsors operating in the EU face “critical challenges” when trying to set up clinical trials that require the use of in vitro diagnostics (IVD), according to EFPIA officials, who have called on the European Commission to take up the challenges to avoid damaging the local clinical trial environment.
In the statement, the EFPIA (European Federation of Pharmaceutical Industries and Associations) expressed its full support for the In Vitro Diagnostics Regulation (IVDR), which entered into force on May 26, but warned that the EU was still faces critical challenges “which could ultimately lead to a reduction in clinical trial sites in Europe” and delayed patient access to new therapies. IVDs in clinical trials.
“To date, neither the streamlined process created by the IVDR to facilitate the review of applications for IVDs used in clinical trials, nor the support infrastructure and guidance needed to enable companies to operate in a fully reliable and operational, are in place,” wrote the trade group.
Unless the Commission acts, the EU could suffer “unintended consequences” that damage the clinical trials environment, according to EFPIA, which called on the Commission to address critical challenges and offered to “participate to a constructive dialogue “about potential solutions and directions” that will enable the optimal use of IVDs in clinical research.
EFPIA released the statement just over a week after the Medical Devices Coordination Group (MDCG), which advises the Commission on IVDR-related issues, published a question and answer document on the interface between the new regulations on clinical trials and IVDs. The document explains how the IVDR applies to diagnostics used in clinical trials to support the coordinated evaluation of deposits to conduct multi-country studies.
“The purpose of this Q&A is to support these coordinated assessments by providing clarity on the regulatory status of testing performed on human samples used in clinical trials as well as regulatory expectations of clinical trial sponsors. The overall goal is to support the conduct of clinical trials using diagnostic tests, including combination trials for the development of companion diagnostics,” the MDCG wrote.
Italy prepares for the June launch of the National Pharmacovigilance Network, data format
Italy is preparing to launch a new National Pharmacovigilance Network (RNF) and international standard format for collecting adverse reaction data on June 20. The changes will enable a new online method for reporting adverse events to the Italian Medicines Agency (AIFA).
From June 9, Italy is in a transition phase where healthcare professionals and patients will need to email details of suspected side effects using reporting forms. Relevant stakeholders can either send emails to the product’s Marketing Authorization Holder or their institution’s Pharmacovigilance Manager.
The transition phase will continue until June 20, when RNF will go live. RNF is designed to have “advanced functions for managing and analyzing reports of suspected adverse reactions in order to ensure an increasingly precise assessment of the safety profile of medicinal products”. The changes include the adoption of a new method of presenting information.
Italy’s switch to the new system will also see it replace its current Vigifarmaco portal. AIFA deactivated the portal on June 8 in preparation for the launch of reporting via its own portal. The new process will be in line 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. The switch to the new format will allow Italy to link RNF to the EudraVigilance system to share adverse event reports.
Spain reports 160% increase in reports of suspected adverse events
The Spanish Agency for Medicines and Medical Products (AEMPS) reported a 160% increase in the number of reports of suspected adverse events. COVID-19 vaccines drove the uptick in activity.
As in the wider EU region, where the number of suspected adverse reactions to authorized products increased by 93% in 2021, COVID-19 vaccines account for all of the additional activity. Last year, AEMPS received 81,447 reports 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 adverse reaction reports suspected adverse reactions fell to 26,331.
Regulators expected the number of reports of suspected adverse reactions to rise rapidly in 2021, as millions of people received newly authorized COVID-19 vaccines. While managing the additional pharmacovigilance workload, AEMPS also carried out 21 national and international inspections related to the production of COVID-19 vaccines. By April 2022, Spain had manufactured 460 million doses of mRNA vaccines.
Other COVID-19 related activities declined in 2021. AEMPS saw a 73% drop in compassionate use requests last year, as well as a 10% drop in the number of actions taken to ensure the availability of medicines. The number of authorized clinical trials has increased from 1,027 to 996. Nearly 5% of authorized trials last year were for COVID-19.
Notice AEMPS (Spanish)
France updates good pharmacovigilance practices to reflect compassionate use reforms
The National Agency for the Safety of Medicines and Health Products (ANSM) has updated its good pharmacovigilance practices (BPV) for the first time since 2018 to reflect developments, in particular the reform of the compassionate use process.
New rules on access to unauthorized medicines by patients with serious, rare or disabling diseases came into force in France last summer. The changes, intended to simplify and speed up the process, have taken into account the revision of the ANSM’s GVP. The ANSM’s GVP document groups products for compassionate use with medicines benefiting from early access authorisation.
The update of the GVP includes other changes relating to the notification and treatment of medication errors and the role of MA holders in the pharmacovigilance process in France.
UK MHRA joins ICH Assembly after Brexit-triggered split from EU delegation
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has joined the International Council for Harmonization (ICH) Assembly as a member, giving it a say in the organization’s activities to the first time since Brexit.
Prior to Brexit, the MHRA participated in ICH activities as part of the EU Delegation, allowing 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 had to attend three of the four consecutive biannual meetings of the ICH to become full members.
The ICH has adopted a fast-track process for regulators that have implemented at least 75% of its guidelines in 2020, giving the MHRA a shorter path to membership. The MHRA has now completed the process, leading to the ICH accepting the agency as a new member. The change allows the MHRA to resume input and voting on ICH activities.
The Finnish Medicines Agency (Fimea) is seeking comments on an assessment of Astellas Pharma’s Padcev in advanced urothelial cancer. Fimea review (Finnish)
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