Euro Roundup: EMA aims to expedite release of meeting recordings

The European Medicines Agency (EMA) has named faster publication of video recordings of workshops and public meetings as an area its communication can improve after running a survey of perceptions of its communication activities.

Overall, the poll, like earlier assessments of perception of EMA communication, found people are mostly satisfied with how EMA shares information. The new survey, which captured responses from 375 people based around the world, found 93% of respondents regard EMA’s communication as either important or indispensable to their organizations. Most, 57%, respondents largely agreed the agency engages enough with stakeholders, and 25% of people said engages better than other regulatory agencies.

Yet, while the topline findings are positive, EMA identified areas it can improve. Two of the opportunities to improve relate to video. EMA wants to ensure “materials, such as videos and infographics shared via EMA’s social media channels, are available and easily accessible via its corporate website” and expedite publication of “recordings of workshops and public meetings to ensure that stakeholders and partners who were unable to attend could access them quickly and easily.”

The focus on video reflects shifts in how EMA shares, and stakeholders ingest, information. When EMA ran its communication perception survey in 2017, the resulting report only referenced “video” once. The medium is a bigger part of the latest report. EMA found 73% of respondents find its videos helpful. Most of the other respondents answered, “Don’t know.” Only 3% of respondents called the videos unhelpful.

EMA posts videos on its YouTube channel but the survey found problems with its approach. Awareness of the YouTube channel is low, 30%, and has declined since the 2020 survey. One person working in the pharma industry criticized EMA for solely distributing information on its social media channels, arguing that “it would be preferable if the information on LinkedIn, Twitter and other social media platforms is mirrored on the EMA web page.” EMA wants to increase awareness and use of its YouTube channel.

Other areas for improvement identified by the agency include: translating communication materials and making them publicly available in languages other than English; continuing to improve the structure, design and functionalities of the EMA website to make it easier to navigate and use; and increasing the use of visual materials.

EMA Report

EMA updates guidance on oral explanation meetings to reflect technological changes

EMA has updated its oral explanation guidance for applicants and marketing authorization holders. The guidance, the previous version of which was published in 2015, provides practical information about oral explanation and discussion meetings with EMA committees and groups.

In the earlier version of the document, EMA said that it “will not dial into a teleconference system or mobile numbers” and advised companies on the need for paper copies of presentations. Under the old guidance, EMA said paper copies should be “provided either in advance of the meeting date via courier, or provided directly to the EMA contact point on the day of the oral explanation.”

EMA has deleted the information on teleconferencing and paper copies from the updated guidance. The rest of the document covers the same points as the old version but EMA has tweaked the information.

Unlike the old document, the updated guidance names the IRIS portal as a way that companies can share presentations with EMA and advises companies against planning more than two or three speakers for a 20-minute presentation. The new guidance also states that “an EMA representative will display and navigate the company’s presentation.”

EMA Guidance

In a first, Swissmedic gets independent confirmation of cell, gene therapy inspection skills

The Swiss Agency for Therapeutic Products (Swissmedic) has become “first and only authority” to receive independent confirmation of its competence in good practice inspections of advanced therapy medicinal products (ATMPs).

Bodies that perform good manufacturing and distribution practice (GMP/GDP) inspections in Switzerland must have the legally prescribed ISO 17020 accreditation. The accreditation confirms the body has a functioning quality management system and assesses the expertise of its inspectors. Swissmedic holds an accreditation from the Swiss Accreditation Service (SAS).

In its latest audit of Swissmedic, SAS assessed an application to extend the scope of its accreditation to GMP and GDP inspections of ATMPs, a term that covers medicines for human use that are based on genes, tissues or cells. Swissmedic’s ATMP inspections are done “under the functional management of the Inspectorate Unit and have been integrated in the Inspectorate Unit's QM system for many years.”

SAS granted Swissmedic the extension to its accreditation to include ATMP inspections.

Swissmedic Notice

Following FDA alert, MHRA shares recommendations on managing breast implant cancer risk

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on the risk of lymphoma in recipients of breast implants. MHRA issued recommendations for patients and healthcare professionals after reviewing a “very small number of cases” of implant-related lymphoma.

Emerging evidence that squamous cell carcinoma (SCC) and different types of lymphoma can develop in the fibrous capsule that forms around breast implants led the US Food and Drug Administration to publish notices in September and March. The SCC cases differ from the breast implant associated anaplastic large cell lymphoma that was identified in 2016.

Responding to the SCC cases, MHRA has recommended that people with implants continue to routinely monitor their breasts for any changes. MHRA is advising people who are considering having breast implants to obtain written information about the benefits and risks and discuss the tradeoffs with their healthcare professional.

The agency is asking healthcare professionals to include the potential risk of SCC and different types of lymphoma in the informed consent procedure for new patients and report suspected adverse events.

MHRA Guidance

EMA posts alert about methotrexate shortage after unexpected rise in demand strains supply

EMA has issued an alert about a shortage of methotrexate after “an unexpected increase in demand” and “delays in production” led to supply disruptions in European countries including France, Germany and Italy.

Methotrexate is used in patients with cancer and people with inflammatory diseases such as rheumatoid arthritis. In the US, manufacturing delays at Accord Healthcare have caused a shortage of its product and alternative methotrexate formulations from Fresenius Kabi, Pfizer and Hikma are on backorder because of increased demand.

The problem has spread to Europe. In its notice, EMA said “different manufacturing issues are affecting the supply of methotrexate injections in some European countries.” EMA is advising healthcare professionals to ensure that enough supply is available to complete treatment, particularly in cancer patients, before prescribing the drug. Physicians should consider alternatives if supplies are limited.

EMA Alert

Other News:

Swissmedic has confirmed its participation in EMA’s OPEN initiative. The Opening procedures at EMA to non-EU authorities (OPEN) initiative allows overseas regulatory agencies to participate in and contribute to its scientific assessments. EMA listed Swissmedic as a participant in the initiative when it expanded the scope of the program beyond COVID-19 last month. Swissmedic Notice

MHRA has updated its guidance on reporting adverse incidents and field safety corrective actions related to medical devices. The update covers the submission of reports via the MORE portal. MHRA Guidance

Euro Roundup: EMA aims to expedite release of meeting recordings

Related topics

Recommended content

Welcome to the new RAPS Digital Experience