Euro Roundup: Commission proposes ‘regulatory flexibilities’ against drug shortages

The European Commission (EC) has identified “regulatory flexibilities” as one measure that could help avoid shortages of key antibiotics this winter.

After seeing supply disruptions last year, the EU has formulated a plan for avoiding critical shortages of key products over the coming months. Regulatory flexibilities are “an important tool to manage and mitigate shortages of critical medicines,” according to the document. Specifically, the Commission’s actions facilitate the quick authorization and rollout of alternatives, upscale production or approve alternative suppliers, temporarily extend shelf-life, and enable redistribution between member states.

While these flexibilities deviate from standard regulatory practices intended to protect patients, experience with such flexibilities gained through the COVID pandemic “offers confidence that they can be used without compromising safety and quality standards,” according to the Commission.

Europe’s Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) provided more details of how the flexibilities may be used this winter, explaining that competent authorities will decide whether to apply its recommendations on a case-by-case basis. MSSG is reserving some flexibilities, such as batch-specific deferral of release testing, for exceptional situations.

The Commission is working with the European Medicines Agency (EMA) and member states to formalize its approach to regulatory flexibilities. The groups are working on a Joint Action to promote the effective use of regulatory flexibilities and other flexibilities that could be applied at the national level, “such as how the magistral preparations of local pharmacies might be used to mitigate certain shortages.”

Regulatory flexibilities are part of a range of actions that authorities will consider to prevent shortages. A voluntary solidarity mechanism, based on an informal arrangement used during the pandemic, will allow member states to ask other EU countries for help sourcing medicines. The mechanism is intended to be used as a last resort.

Medicines for Europe, a trade group that represents off-patent drugmakers, welcomed the effort, hailing it as “an important step to tackle the root causes of shortages.” The trade group is pushing for the creation of a Critical Medicines Act to further protect the EU from drug shortages.

Press Release, EMA Notice, Industry Response

Team-NB urge manufacturers of class D devices to submit IVDR filings this year

A notified body trade group has urged manufacturers of class D devices to seek certification under the In Vitro Diagnostic Regulation (IVDR) this year to ensure their applications are processed by the deadline.

The EU extended the IVDR transition last year to avoid disruption to the supply of tests, but Team-NB, a trade group that represents notified bodies, is still concerned that its members will struggle to process all the certification requests by the new deadlines. The group’s concerns reflect the length of IVDR reviews, which last 13 to 18 months for high-risk devices, and data on the number of submissions made to date.

“Notified bodies have the capacity to accept applications under IVDR and complete the conformity assessment process in time if the applications are submitted without delay,” Team-NB wrote. “For class D devices, it is strongly recommended to submit the applications no later than the end of 2023, that will allow technical documentation assessments to start in time.”

The focus on class D devices reflects the staggered timeline for IVDR compliance. Manufacturers of class D devices, which test for life-threatening conditions, must comply with IVDR by 26 May 2025. A survey earlier this year found that notified bodies had received 231 class D applications.

Team-NB members have “jointly committed themselves to make time and resources available to process the device applications and complete the conformity assessments ... if the applications are submitted in good time,” the trade group wrote. If a filing is not submitted in time, notified bodies “cannot guarantee that the conformity assessments and certification will be processed successfully before the transition timelines end, leading potentially to problems in the supply chain and access to IVDs in the EU.”

Team-NB Notice

MHRA, North American partners create principles for machine learning in medtech

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has teamed up with its North American counterparts to publish five guiding principles for machine learning-enabled medical devices (MLMDs).

Working with the US Food and Drug Administration (FDA) and Health Canada, MHRA has established a policy on predetermined change control plans (PCCPs). The regulators have identified PCCPs as a way to enable manufacturers to secure preauthorization for certain planned modifications to MLMDs and facilitate rapid, ongoing change management.

The guiding principles state PCCPs should be focused and bounded, describing specific changes that a manufacturer plans to make; driven by a risk-based approach; supported by evidence generated throughout the lifecycle; and transparent. The fifth principle calls for PCCPs to be created and used from a total product lifecycle perspective.

MHRA plans to publish national guidance based on the principles next year. The principles will support PCCP development in the UK, US and Canada, and show areas where the agencies are aligned, but each regulator will have its own guidance for manufacturers to follow. Companies in the US can comment on the principles via an FDA docket.

Press Release, PCCP Guidance

Coalition calls for ‘major rethink’ to avoid EU creating ‘one-sided, litigation-friendly regime’

A coalition of trade groups across multiple industries is calling on the EU to revise its planned Product Liability Directive (PLD). In their second letter in five months, the organizations pushed for a “major rethink” of plans they predict will “open the door to a litigation culture in Europe.”

Trade groups, including EFPIA and MedTech Europe, wrote to EU authorities in May to warn that planned changes to the PLD may cause “a rise in litigation and speculative claims” (RELATED: Euro Roundup, Regulatory Focus, 18 May 2023).

The latest letter uses stronger language, warning that “there will be immense pressure, particularly for smaller companies, to settle cases rather than fight unmeritorious claims” and that “third-party litigation funders” will prosper.

The trade groups have narrowed the focus of their call for change to three key points. They want authorities to limit the alleviation of the burden of proof, provide safeguards for the disclosure of evidence and ensure the scope is fit for purpose.

The trade groups timed the letter to coincide with the start of trilogues, the interinstitutional EU negotiations that will shape the final PLD.

Joint Letter

Other news:

EC expert panels have advised the Medical Device Coordination Group (MDCG) on COVID-19 antibody tests. MDCG requested advice on whether a serological test can claim detection of neutralizing anti-SARS-CoV-2 antibodies and, if not, what studies would support the claim. The response focuses on the need to differentiate between binding and neutralizing antibodies. Report

EMA has spread the message about falsified Ozempic, issuing a notice that pre-filled pens falsely labeled as the medicine have been found at wholesalers in the EU and UK. The alert follows notices by authorities in countries including Germany and Switzerland. EMA Notice

Euro Roundup: Commission proposes ‘regulatory flexibilities’ against drug shortages

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