Euro Roundup: EC seeks feedback on medtech joint clinical assessments

The European Commission is holding a consultation into joint clinical assessments of medical devices and in vitro diagnostics under the Health Technology Assessment Regulation (HTAR).

Last year, the European Union adopted HTAR implementing regulations on joint scientific consultations for medicinal products, joint clinical assessments, managing conflicts of interest and collaborating with the European Medicines Agency (EMA). The new consultation, which is open until 25 June, covers the last HTAR implementing act. The act will complete the legislative framework for HTAR implementation.

The draft implementing regulation sets out procedural rules for how companies and officials should prepare for joint clinical assessments of devices and in vitro diagnostics and interact and exchange information once the process is underway.

Because the device certification process is confidential, the Commission will only select products for joint clinical assessments once they have received a CE mark. Regulatory and HTA assessments of medicines can take place in parallel. To prevent duplicated assessments of devices, the Commission is proposing to start joint clinical assessments of devices as soon as they are certified.

To achieve that goal, the Commission wants the HTA secretariat to tell medtech developers when one of their devices is selected for assessment. The draft regulations also require notified bodies to tell the HTA secretariat the results of the certification process for any devices selected for assessment. Developers will be invited to submit information to the HTA secretariat once they receive a certificate of conformity.

The HTA secretariat and EMA will conduct the exchange of information between the Coordination Group and expert panels. The HTA secretariat will be responsible for ensuring all the information it receives is sent to the Coordination Group, the subgroup of the Coordination Group on joint clinical assessments and the assessor and co-assessor for joint clinical assessment, as needed.

The Commission wants to see deadlines for the finalization of the assessment scope and the draft joint clinical assessment reports by the JCA Subgroup. Adopting deadlines is intended to ensure the timely availability of joint clinical assessment reports. The Commission wants the JCA Subgroup to hold off on finalizing the assessment scope until a device is selected for assessment to make best use of resources.

Officials are running the consultation in parallel to a call for applications from companies that want to take part in a joint clinical assessment. The submission period, which runes from 2 to 30 June, is open to developers of medicinal products and medical devices.

Commission Notice, Public Consultation

EMA plans gastrointestinal tract drug interaction guideline to close gap created by ICH M12

EMA has published a concept paper on investigating drug interactions in the gastrointestinal tract. The paper is designed to close a gap created by the adoption of an International Council for Harmonisation (ICH) document.

ICH M12 replaced EMA’s guidance on drug interactions in November. However, the old guideline covered topics that are missing from ICH M12. EMA released an implementation strategy with temporary actions for addressing the situation, identifying 10 topics that are missing from ICH M12 and still covered by the old guideline, and set out plans to create a new document to provide a permanent solution.

Now, the agency has advanced the strategy by publishing a concept paper that proposes a guideline on certain topics not covered by ICH M12. The ICH text covers pharmacokinetic drug interactions mediated by metabolic enzymes and drug transporters, EMA said, but lacks advice on drug interactions mediated in the upper gastrointestinal tract.

“There is a risk of creating a gap in regulatory guidance for the assessment of gastrointestinal drug interactions, an important component of evaluating a new drug’s interaction potential,” EMA said. “To address this, a dedicated guideline is proposed to provide updated and specific recommendations for investigating gastrointestinal interactions.”

The guideline will address the investigation of food effect for new, orally administered medicines and interactions affecting solubility caused by complex formation, changes in gastric pH and excipients. Other proposed topics include interactions that impair enterohepatic circulation or affect gastric emptying and gastrointestinal motility.

EMA skipped the typical consultation period for the concept paper because it addresses the need to update and replace existing guidance. The agency plans to hold a six-month consultation into the draft guideline once it is ready for public review.

Concept Paper

EMA outlines impact of phasing out rabbit pyrogen test on marketing authorizations

EMA has advised marketing authorization holders on the phasing out of the rabbit pyrogen test from the European Pharmacopeia.

Labs run rabbit pyrogen tests to assess if a substance causes fever. The revised European Pharmacopeia has a new general chapter on pyrogenicity to establish alternative methods. Officials are also deleting references to the rabbit pyrogen test from 57 monographs. The implementation date for the new and revised texts is July 1.

Ahead of the deadline, EMA has updated its medicine quality question and answer document to explain the implications of the changes. The agency said companies should remove the rabbit pyrogen test from their marketing authorization dossiers and assess the need for a replacement method.

Applicants and authorization holders should run a risk assessment and assess the potential presence of pyrogens, EMA said. Companies are responsible for choosing a testing strategy and limits. EMA referred companies that need a new method to the general chapter on pyrogenicity. A new method may not be needed if the risk assessment shows the existing controls include a suitable method.

Any removal or replacement of the rabbit pyrogen test from the marketing authorization dossier will necessitate the submission of a variation for assessment. The type of submissions depends on whether the authorization holder is proposing an alternative method or relying on a method that is already in the approved dossier.

EMA Q&A

Swissmedic clarifies GMP compliance requirements for foreign manufacturers

The Swiss Agency for Therapeutic Products (Swissmedic) has revised its guidance on good manufacturing practice (GMP) compliance by foreign manufacturers.

Under Swiss law, foreign companies must show they work in accordance with Swiss GMP requirements. Typically, manufacturers provide documents issued by authorities with GMP control systems equivalent to Swiss standards to meet the requirement. Companies that lack such certificates can provide an audit report as proof of GMP compliance under certain conditions.

Swissmedic’s updated guidance clarifies the topics that companies should take into account during the audit. The guidance now features general conditions for the submission of audit reports. The conditions cover the need for the audit report to be available when a manufacturer submits an application and the acceptance of re-audit reports.

“Audit reports from a re-audit with a reduced, risk-based audit scope are also accepted as audit reports. In these cases, however, it must be ensured that all information required for the assessment of GMP compliance is still submitted. This can be done, for example, by submitting an assessment prepared by the RP or a summary based on the original complete audit covering the missing points,” Swissmedic said.

Swissmedic has also updated the information on the submission of GMP certificates from equivalent regulatory authorities. The Swiss agency will accept certificates issued in the past three years based on the findings of on-site inspections. The amended guidance is now in effect.

Swissmedic Notice

Euro Roundup: EC seeks feedback on medtech joint clinical assessments

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