Euro Roundup: EMA posts guidance on declarations under the HTA Regulation

The European Medicines Agency (EMA) has shared guidance on how applicants can declare whether a submission falls under the scope of the Health Technology Assessment Regulation (HTAR) and is subject to a joint clinical assessment (JCA).

The HTAR requires health technology developers to declare if an application is subject to JCA when they file a letter of intent. The submission of the letter intent, which typically happens around seven months before the planned approval filing, allows EMA to appoint rapporteurs in preparation for the upcoming review of the application.

Starting in 2025, some companies will need to use the letter to declare a submission is covered by HTAR. EMA explained the timeline and process in an update to its pre-authorization procedural advice for users of the centralized procedure.

As of 13 January 2025, developers of new active substances in cancer indications and advanced therapy medicinal products such as cell therapies will need to declare their filings are subject to HTAR. The filing requirement expands to cover orphan medical products in January 2028 and all other medicinal products that are within the scope of HTAR in January 2030.

“EMA and the secretariat of the Member State Coordination Group on HTA (HTACG) have agreed to use the same form for respective notifications,” EMA said. “For products in the scope of JCA, the HTACG advises applicants to send the Letter of Intent (submitted to EMA) in parallel through the HTA IT platform. This will enable the JCA pre-submission phase to start in parallel to the MAA pre-submission phase.” EMA updated its pre-submission request form last week.

In a separate notice, the European Commission explained that applicants should send HTACG a request to access the HTA IT platform by email. HTACG will then tell the applicant how to upload a copy of the letter of intent to the platform.

EMA reminded applicants of the need to let it know if their intended submission date changes or if they opt against seeking approval. Applicants covered by HTAR should also send information about the new submission timeline to HTACG.

The Commission also began a consultation on cooperation with EMA under HTAR. Officials outlined the plan in a draft implementing act that will create rules on sharing information and planning JCAs and joint scientific consultations, including how to identify patients and experts to participate in the process. The draft is open for comment until 24 July.

Commission Statement, EMA Guidance, HTA Consultation

EMA adopts opinion on quantifying brain amyloid deposition after feedback from Eli Lilly

EMA’s Committee for Medicinal Products for Human Use (CHMP) has ruled the Centiloid Unit can be considered a validated measure of global amyloid load in the brain for enrichment in clinical trials. The opinion is contingent on the method being properly used with quality control procedures.

In 2015, researchers at Avid Radiopharmaceuticals, a subsidiary of Eli Lilly, co-authored a paper on how to standardize quantitative amyloid imaging measures. The work was intended to improve assessment of a key biomarker of Alzheimer’s disease by creating methods for analyzing and scaling PET data. The researchers named the units of the scale “Centiloids.” CHMP shared its opinion on the method this week.

“The Centiloid Unit can be used for enrichment in clinical trials considering existing qualification opinions on the use of amyloid PET-imaging as biomarkers for enrichment in regulatory clinical trials in mild to moderate Alzheimer’s disease and in predementia AD,” CHMP said.

CHMP reached its final qualification opinion after organizations including Lilly shared feedback on the draft position it adopted in March. The committee retained the opinion from the draft in the final text but made small changes in response to feedback. For example, CHMP reworded a line to make it clear it meant harmonizing inherent resolution of different scanners after Lilly noted the risk of confusion.

Qualification Opinion, Industry Feedback

EDQM shares chapter on extractable elements in plastic materials for pharmaceutical use

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has shared details of a new general chapter on extractable elements in plastic materials for pharmaceutical use. The chapter will be published in September.

Implementation of the ICH Q3D guideline has changed how the industry handles elemental impurities. The directorate said the industry is moving from pure substance-based testing to a holistic control strategy at the medicinal product level. That shift has implications for extractable elements originating from plastic containers for pharmaceutical use and closures.

The plastics are outside the direct scope of ICH Q3D, EDQM said, but “their quality has an impact on the final quality of the manufactured container as they are used as the material of construction.” That led the European Pharmacopoeia to develop and validate a procedure for assessing extractable elements in different plastic materials available on the European market. Feedback drove changes to the first draft.

“The revised text now covers only the analytical procedure for testing of extractable elements in plastic materials for pharmaceutical use. The initially proposed mandatory limits for extractable elements have been omitted from the final version. These limits will be provided as a recommendation in a new general text,” EDQM said.

EDQM Notice

Swissmedic prepares medtech industry for activation of medical devices database module

The Swiss Agency for Therapeutic Products (Swissmedic) is preparing to bring the first module of the swissdamed medical devices database online on 6 August.

Swissmedic has created the database to address changes to Switzerland’s relationship to the European Union that cut off its access to Eudamed. The changes forced Swiss manufacturers, importers and authorized representatives to register with Swissmedic to obtain a CHRN unique registration number. When the module goes live, the registration process will change.

The Swiss agency will stop accepting applications for registration and for changing the CHRN, as well as notifications for mandates, as PDF forms after 26 July. On 6 August, the actors module of Swissmedic will go live and economic operators will register via the swissdamed website.

Swissmedic will migrate data on almost 3,700 economic operators who have already registered to the new system. Registered operators will receive a letter at the start of August asking them to check their data on swissdamed.

Swissmedic Notice

EMA provides recommendations for tackling shortages of GLP-1 receptor agonists

EMA and the Heads of Medicines Agencies have shared advice on how to tackle shortages of GLP-1 receptor agonists such as Novo Nordisk’s Ozempic (semaglutide).

Demand for the molecules, which are used to treat diabetes, overweight and obesity, soared in 2022. Rising demand and manufacturing capacity constraints combined to create shortages in the European Union and beyond. Now, the Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG) has provided recommendations for improving supply.

MSSG has advised member states to consider working with marketing authorization holders to “control and optimize” distribution of the medicines. The steering group is also encouraging member states “to develop guidelines to facilitate prioritization of patients who have the greatest need for the medicines.”

Other actions center on marketing authorization holders. MSSG said claims made by companies in the promotion of the drugs “should align with rational medicine use and public health goals.” The group also wants companies to “consider implementing awareness campaigns on weight management and educational activities on the ongoing shortage and its implications for clinical practice.”

EMA Notice

Euro Roundup: EMA posts guidance on declarations under the HTA Regulation

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