Euro Roundup: EMA starts monitoring advice and assistance trends after requests plummet
The European Medicines Agency (EMA) has started monitoring demand for scientific advice and protocol assistance after seeing requests for the services fall 26% year on year over the first half of 2023.EMA recently shared a mid-year report with its management board, which noted the steep drop-off. The agency is taking the trend seriously enough to take a closer look at how demand changes over time.
“The agency will monitor this development to identify whether this is a trend or a normal fluctuation as applications are typically not spread out evenly over the year. In previous years the agency had also received a significant number of COVID-19-related scientific advice requests, a trend which is no longer expected,” EMA wrote in its summary of the meeting.
While requests for advice and assistance fell, EMA tracked increases in several other areas. For example, the number of biosimilar applications doubled from four to nine between the first halves of 2022 and 2023.
EMA Notice
Indian Pharmacopoeia Commission joins EDQM in global Pharmacopoeial Discussion Group
The Indian Pharmacopoeia Commission (IPC) has joined the Pharmacopoeial Discussion Group (PDG) set up by officials in Europe, Japan and the US.
PDG accepted the Indian commission into a one-year pilot in October 2022, advancing a move to expand its ranks beyond the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia (RELATED: Indian Pharmacopoeia joins global discussion group pilot, Regulatory Focus, 13 September 2022). The three pharmacopeias have harmonized tens of general chapters and excipient monographs since PDG began operations in 1989 but need other bodies to join to increase their impact.
The European Directorate for the Quality of Medicines and HealthCare (EDQM) welcomed IPC into the group via a statement. Cathie Vielle, secretary to the European Pharmacopoeia Commission, hailed the inclusion of IPC as a way to “further advance convergence around robust science‐based quality standards across pharmacopeias for the benefit of public health.”
EDQM Notice
MedTech Europe calls for ‘realistic’ move away from PFAS to avoid medical device shortages
MedTech Europe has called for authorities to provide a “realistic transition pathway” away from per- and polyfluoroalkyl substances (PFAS) to avoid shortages of medical devices.
Early this year, the European Chemicals Agency proposed restricting around 10,000 PFAS because they persist in the environment and could harm people, plants and animals as they accumulate.
“Sufficiently broad derogations should allow sufficient time to first identify all PFAS uses in medical technologies and to subsequently move to alternatives where these are proven to be technically viable. A realistic timeline must consider the sector’s complex supply chain dependencies as well as the long development timelines,” MedTech Europe wrote in a statement.
Press Release
Germany finds counterfeit Ozempic, warns that fakes pose significant health risks
A German regional council has warned that counterfeit copies of Novo Nordisk’s Ozempic (semaglutide) are circulating in the country. The notice prompted the Swiss Agency for Therapeutic Products (Swissmedic) to issue an alert about the German situation and the fact “counterfeits are increasingly appearing on the market.”
Officials at the Freiburg Regional Council worked with Germany’s Federal Institute for Drugs and Medical Devices to put out the original notice. The notice warned that fake copies of Ozempic, a diabetes drug that is also used to treat obesity, are circulating in Germany and are highly likely to pose significant health risks. Authorities have seized some counterfeits but cannot rule out that more are on the market.
Officials are working with authorities in other countries because there are indications that the fakes are in supply chains outside of Germany. Swissmedic published a notice about the discovery of counterfeits in Germany days after the release of the Freiburg alert. The Swiss regulator said counterfeits should not be used and should be taken to a pharmacy.
Press Release (German), Swissmedic Notice
EMA answers questions on applying model-informed drug development to neonate studies
EMA has updated its question-and-answer document on modeling and simulation with new advice on the application of model-informed drug development (MIDD) to neonate studies.
The agency highly recommends using MIDD approaches in pediatric drug development because of the “practical and ethical limitations” on the collection of experimental pharmacokinetic (PK), pharmacodynamic and clinical data in children.
In its recent document, EMA explains that population PK modeling and physiological based pharmacokinetic modeling are the two main approaches for predicting PK in neonates, but the complexity of how newborns process drugs means no standard approach fits all situations. There are limits to what is known, with EMA stating the regulatory system lacks experience of predicting PK in low birth weight and preterm neonates.
That said, EMA sees a role for MIDD in neonates, explaining how the approaches can justify critical design features, such as the number of patients, and inform the feasibility of the proposed trial design.
EMA Q&A
MDCG updates manual on borderline medical devices, adding classifications for five products
The Medical Device Coordination Group (MDCG) has added more products to its manual on the classification of borderline technologies.
National authorities are responsible for determining if a product is a medical device in their markets. Yet, the European Union is concerned that differing interpretations will pose risks to public health and distort the internal market, leading MDCG to work with member states to reach agreements on the classification of products.
In its recent update, MDCG added agreed classifications for root canal irrigation solution, temperature sensors embedded in orthopedic devices for compliance tracking, systems intended to produce sclerosing foam, n-butyl-2-cyanoacrylate based adhesives and custom-made cranial implants.
MDCG Guide
EMA offers free meetings to pharma companies with big medicinal product portfolios
EMA has begun offering pharma companies with large medicinal product portfolios the chance to talk to its staff in informal, free-of-charge, virtual meetings.
The agency sees the meetings as a way for industry and regulators to identify any issues impacting the progress of product portfolios, capture new and disruptive technology already in use, and anticipate the scientific and regulatory expertise needed to assess future applications.
EMA is accepting applications to attend a portfolio and technology meeting next year until 10 November. Interested parties need to complete a form that features questions about their pipeline, technology and therapeutic focus. The form includes space for eight suggested topics of discussion at the meeting. EMA is encouraging applicants to consider topics in the context of its Regulatory Science Strategy to 2025.
EMA Notice
Other news:
Ireland’s Health Products Regulatory Authority (HPRA) has overhauled its guide to refusals and appeals under scientific animal protection legislation. The guide explains the options that are open to researchers when HPRA refuses an application related to the use of animals for scientific purposes. HPRA Guide
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