Euro Roundup: EMA updates IDMP Implementation Guide, plans further revisions

RoundupsRoundups | 25 February 2021 |  By 

The European Medicines Agency (EMA) has updated its identification of medicinal products (IDMP) implementation guide, providing additional details on topics including the basis for medicinal product data exchange in the European Union in its version 2.0.
EMA picked out the addition of “high level principles of the target operating model for submitting and maintaining medicinal product data in the EU” as an area that has changed since version 1.0. EMA has also added further advice on how to populate the product management service (PMS) data elements.
The new content adds to the early information on EMA provided on technical specification, data elements and associated business rules last year to help the industry prepare for the implementation of IDMP standards.
Following the update, EMA said the text features detailed guidance on the registration requirements, information on product data access and practical examples intended to help users structure product data correctly. The guide is intended to form the basis for practical preparation activities and give the European regulatory network the information needed to submit data.
Step 1 of PMS implementation is set to start at least 12 months after the release of version 2.0 of the IDMP guide. Tweaks to version 2.0 are planned for later in the year. EMA said no substantial changes to the submission process are planned. Rather, EMA will use the updates to add details about the migration and enrichment of data.
EMA is also starting to make plans for a third version of the guide that will be designed to support step 2 of the PMS implementation. The third version will feature additional chapters covering step 2 of the implementation.
EMA Update
MHRA retains recommendations on paclitaxel devices after independent review
The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) has retained its position on paclitaxel-coated devices after seeing the findings of an independent expert advisory group. MHRA is continuing to advise against the use of the devices in patients with intermittent claudication while telling physicians the benefits may outweigh the risks in other populations.
MHRA originally formed the paclitaxel expert group in response to a 2018 meta-analysis that linked devices featuring the drug to increased mortality. The group issued its first report in mid-2019, at which time it recommended against the use of the devices in patients with intermittent claudication, a pain in the leg caused by the lack of blood flow but supported their use in other indications.
The team behind the 2018 meta-analysis published new findings at the start of last year. The paper raised additional concerns about the use of paclitaxel-coated devices in patients with critical limb ischemia (CLI), leading MHRA to reconvene the expert group to review the new evidence.
After analyzing the data, the experts concluded they “cannot say that additional, specific, measures are needed for CLI patients.” The experts also found insufficient evidence to explain any potential relationship between paclitaxel-coated devices and mortality or amputation.
Faced with the uncertainty, the experts recommended revising the actions for clinicians so that they refer to usage in CLI but opted against advising against the use of the devices in the patients. MHRA responded by updating its advice to clinicians to state decisions about treating CLI “should follow that outlined in the NICE guideline on Peripheral arterial disease: diagnosis and management.”
MHRA is continuing to monitor the devices and act on other findings of the expert review, such as the recommendation to evaluate the evidence supporting the use of the products in other settings including neuro-intervention and arteriovenous fistula access.
MHRA Notice, Expert Report
EMA plans decision on expanded label for Gilead’s Veklury before summer
EMA is evaluating whether to authorize Gilead Sciences’ Veklury for use in adult COVID-19 patients who do not require supplemental oxygen. The agency plans to decide before the summer.
Gilead won EMA approval for the antiviral drug Veklury (remdesivir) in adolescents and adults with pneumonia requiring supplemental oxygen due to COVID-19 in July 2020. The US also initially limited use of Veklury to hospitalized patients with low oxygen levels or supplemental oxygen needs but expanded the label last year. EMA is now considering its own label expansion.
Evidence on the use of Veklury in patients hospitalized with moderate COVID-19 who do not require supplemental oxygen is mixed. The ACTT-1 clinical trial found no significant benefit to Veklury over placebo in patients with mild-to-moderate COVID-19, none of whom required supplemental oxygen.
However, the subgroup only featured 138 patients and other trials have generated more encouraging data. A Gilead-sponsored clinical trial linked Veklury to a statistically significant improvement in the likelihood of a patient with moderate COVID-19 having a better clinical status at day 11. Overall, the data were strong enough to get an expanded FDA label but too weak to change U.S. care guidelines.
In its materials for the original Veklury approval, EMA noted that in ACTT-1 no difference was seen between the outcomes of mild and moderate COVID-19 patients on remdesivir and placebo. EMA is yet to publicly discuss the evidence that will inform its decision about whether to expand the label.
EMA Notice
EDQM sets April implementation date for rapidly revised sartan monographs
The European Directorate for the Quality of Medicines (EDQM) is set to implement five monographs for sartans on 1 April. The monographs, which were adopted using the rapid revision procedure, are intended to align European Pharmacopoeia requirements with the latest regulatory decisions.
Key changes to the monographs for valsartan, losartan potassium, irbesartan, candesartan cilexetil and olmesartan medoxomil include the deletion of a section on N-nitrosamines tests and the revision of the production section. The new production section addresses the threat posed by N-nitrosamines and how manufacturers can mitigate the danger.
“Manufacturers of valsartan for human use are expected to perform an assessment of the risk of N-nitrosamine formation and contamination during their manufacturing process; if this assessment identifies a potential risk, the manufacturing process should be modified to minimise contamination and a control strategy implemented to detect and control N-nitrosamine impurities in valsartan,” the valsartan monograph states.
EDQM shared the monograph update the day after the European Medicines Regulatory Network (EMRN) published a report on nitrosamine impurities. The EMRN report describes the findings of the Committee for Medicinal Products for Human Use review of nitrosamines, before going on to outline the processes for detecting contaminants and the responsibilities of different parts of the European regulatory network.  
EDQM Notice, Press Release, EMRN Report
Other News:
The Swiss Agency for Therapeutic Products (Swissmedic) has issued a notice about delayed injection site reactions in recipients of Moderna’s COVID-19 vaccine. Some Swiss recipients of the vaccine have reported developing redness and swelling near the injection site around one week after getting their jabs. Swissmedic said the cases are in line with reports of “COVID arm” in other countries and are not a reason to skip or delay the second dose. Swissmedic Notice
Ireland’s Health Products Regulatory Authority (HPRA) has shared details of a fraudulent email that is designed to look like it was sent by the agency. The email, which comees from the domain, falsely claims HPRA’s bank account details have changed. HPRA Notice


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy