Euro Roundup: European Council, Parliament reach informal deal on contentious HTA regulation

The European Council and Parliament have reached an informal deal on a planned health technology assessment (HTA) law. European Union officials are working on the HTA law to support cross-border cooperation on the clinical assessment of health technologies.

Full details of the compromise are yet to emerge, but the agreement has already come under attack. Pharma trade group EFPIA said, “The failure to agree on a predictable, efficient and non-duplicative system is a missed opportunity.” EFPIA leveled similar criticisms at the Council when members of the EU body set out their negotiating position earlier this year.

Attention now turns to the adoption of the agreement by the Council and Parliament, and beyond that to the implementation of the law. The regulation will replace project-based cooperation with a permanent framework for joint work and take effect in stages over a three-year period. EFPIA is pushing for the EU to commit the resources needed to make the regulation work.

“The collective focus should be on ensuring effective implementation of the framework in a well-resourced system,” EFPIA said. “We believe the HTA Regulation should be a launchpad for more systematic, scientific and evidence-driven joint work to advance the speed, quality and efficiency of decision making to foster faster, more equitable access to medicines for patients across Europe.”

Council Notice, Commission Notice, EFPIA Statement

EMA starts consultation on computerized systems and electronic data in clinical trials

The European Medicines Agency (EMA) is seeking feedback on a guideline on computerized systems and electronic data in clinical trials. EMA has created the 47-page draft guideline to set out its views on the use of electronic case report forms, wearables and other technologies involved in the creation of data in clinical trials.

As EMA describes in the draft text, the use of computerized systems, and the complexity of those systems, has increased in recent years. EMA forecasts further increases in use as decentralized and hybrid clinical trials become more common, leading it to identify a need for guidance that supports the generation of reliable, high-quality clinical trial data and the protection of study subjects in the emerging, technologically enabled drug development environment.

The guideline describes basic principles that apply to all computerized systems used in clinical trials. In that section, EMA explains key points such as what information is considered as electronic source data, the need for governance systems to ensure data integrity and how to implement electronic signatures.

Another section of the text covers computerized systems, explaining the need for the responsible party to maintain a list of data locations and the training requirements for the technology. A longer section provides an equivalent overview of electronic data. In that section, EMA walks through the need to validate all data transfers, how to adopt direct data capture and the specific requirements that apply to sponsors who use cloud computing. EMA said the cloud puts sponsors “at a certain risk.”

The guidance states, “Contractual obligations with the cloud solution provider should be detailed and explicit and refer to all GCP relevant topics and to all relevant legal requirements.” An annex fleshes out how to put appropriate contracts in place to manage risks associated with working with cloud providers and other third parties. The annex states vendors that make it impossible to establish an appropriate contract, for example because they block access to system requirements specifications, should not be used in clinical trials.

Other annexes deal with topics including the validation of computerized systems, user management and security. The security annex outlines the need to perform regular penetration testing of systems that face the internet and the physical and digital policies that can ensure information is protected.

EMA is accepting feedback until 17 December.

Draft Guideline

Swissmedic shares rules on Swiss authorized representatives after splitting from EU

The Swiss Agency for Therapeutic Products (Swissmedic) has published an information sheet about the authorized representatives now needed to sell medical devices in Switzerland.

With Switzerland and the European Union failing to reach a deal to maintain barrier-free access to medical devices, manufacturers now need to meet new requirements. Notably, companies registered in the EU need an authorized representative based in Switzerland. The Swissmedic information sheet sets out the implications of the requirement.

Manufacturers must state the name of the Swiss authorized representative on the product labeling, although it is optional to include the information on the product itself or the instructions for use. The name and address of the representative must appear next to the “CH-REP” symbol and be “clearly legible to the naked eye.”

Swissmedic Notice

Commission and EFPIA post agenda for public-private research and innovation

The European Commission and five biopharma and medtech industry associations have released an agenda for the proposed Innovative Health Initiative (IHI). EFPIA and other bodies created the text to guide public-private research and innovation.

Parts of the plan touch on how products are regulated in the EU. For example, the agenda states IHI may help address regulatory challenges faced by products that combine different technologies and services by “offering a neutral platform for all interested stakeholders to exchange their experience and views on issues such as harmonization of approaches to evidence generation across sectors.”

The Commission and its collaborators also envision regulators being involved in other projects. Regulators are expected to play a role in “the design and development of new or integrated health solutions including via social innovation” and the piloting of real-world data methodologies and tools. “Contribution to regulatory science” is one of the overarching goals of the strategic agenda.

EFPIA Statement, Strategic Agenda

MHRA backs Innova COVID-19 antigen test slammed by FDA in recent warning letter

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has extended the exceptional use authorization for Innova’s COVID-19 antigen test until 28 August. MHRA took the action despite its US counterpart accusing Innova of falsifying data and urging users to throw tests in the trash.

In response to FDA’s warning letter, MHRA began reviewing the information on the Innova test. The Department of Health and Social Care, which is the legal manufacturer of the test in the UK, carried out a risk assessment. Graeme Tunbridge, director of devices at MHRA, said the agency is “satisfied that no further action is necessary or advisable at this time.”

While MHRA has backed the tests, Jo Churchill, the Parliamentary Under-Secretary for Health and Social Care, said the UK teams are “planning to diversify the supply of lateral flow devices and have begun to deploy other products in some settings.”

Key details about how Innova came to have a virtual monopoly in the UK remain undisclosed. After FDA accused Innova of falsifying data, a UK politician sought access to information including the documents that supported MHRA’s authorization. Churchill said, “The information requested could only be obtained at disproportionate cost.” A summary of the evidence is due to be published later in the year.

MHRA Statement

Other News:

The Netherlands’ DEKRA Certification B.V. last week became the fifth notified body designated under the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The Dutch Medicines Evaluation Board (MEB) is seeking feedback on proposed additional risk minimization measures. MEB Notice (Dutch)

Ireland’s Health Products Regulatory Authority (HPRA) has posted guidance on new scientific use animal reporting requirements. HPRA Guidance

The European Commission is holding a COVID-19 therapeutics matchmaking event next month. EC Notice

Euro Roundup: European Council, Parliament reach informal deal on contentious HTA regulation

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