Euro Roundup: Swissmedic updates decentralized clinical trials plan

RoundupsRoundups | 05 January 2023 |  By 

The Swiss Agency for Therapeutic Products (Swissmedic) seeks to “remove obstacles and to facilitate further innovation in clinical research in Switzerland,” according to an updated position paper on decentralized clinical trials (DCT).
In 2021, Swissmedic and the Swiss Association of Research Ethics Committees (swissethics) created a position paper on DCTs for medicinal products. The original document, as well as an update released months later, outlined barriers to running DCTs in Switzerland, such as the fact that “areas of risk are likely to be identified which require modification of the law, perhaps even before a situation in which DCTs can be approved has been reached.”
Swissmedic retained that concern and other challenges in version 2.0 of the document, dated 15 December 2022. Still, the regulator and its collaborators at swissethics seek to change the tone of the debate about running DCTs in Switzerland.
“The intention in general is not to communicate additional regulatory hurdles but rather to remove obstacles and to facilitate further innovation in clinical research in Switzerland,” version 2.0 states. “Swissmedic and swissethics are open for further mutual exchange regarding DCTs in Switzerland.” The authors also noted that the goal is to “encourage and invite stakeholders to intensify the dialogue on this innovative way in conducting clinical trials.”
The position paper also includes a change to the position on electronic signatures. The latest update removes some of the earlier changes to clarify the message, namely that wet-ink signatures are currently required but the acceptability of e-signatures for informed consent is being “clarified.” Swissmedic will update the document as new information becomes available.
The latest update also removes lines about the need for data servers to be in Switzerland or certain other countries. Version 2.0 notes that “compliance with the Swiss Data Protection Act must be guaranteed.”
Swissmedic Paper
Off-patent drugmakers push for packaging flexibility amid antibiotic shortage
Trade groups representing manufacturers of off-patent medicines have called for regulatory agencies to “authorize greater flexibility on packaging and leaflet requirements” in response to recent disruption to the supply of antibiotics.
In a statement, Medicines for Europe and the International Generic and Biosimilar medicines Association said the global generic medicines industry “is aware of the surge in demand” for antibiotics. The surge is “driven by an unusually high rate of respiratory conditions and infections that are occurring as we exit the most acute phase of the COVID-19 pandemic and, in many countries, an unusually high rate of respiratory conditions and infections among children,” according to the trade groups.
They also identified “changes in prescribing protocols leading to a much higher number of prescriptions for certain antibiotic medicines” as a factor in the demand surge.
To better meet demand, the trade groups seek more flexibility on packaging and leaflet requirements. Specifically, they note that such flexibility “should be automatic for hospital products and considered with appropriate safeguards for community products.” Where possible, the trade groups think agencies could reuse the change management process used to manage pandemic demand surges.
In the medium term, the industry wants governments to “rethink the functioning of antibiotic medicines markets to ensure greater availability and security of medicines supply.” As it stands, the off patent drugmakers find “policy models are not conducive to investment in sustainable production for the future.”
Press Release
Ireland’s HPRA updates fee guide in response to rising rates and Clinical Trials Regulation
Ireland’s Health Products Regulatory Authority (HPRA) has updated its guide to fees for human products to reflect changes to its rates and the progress of the transition to the Clinical Trials Regulation (CTR).
In updating the guide, published last summer, HPRA has changed the fees quoted in its examples considering the recent rate rises and clarified how CTR will affect how and what companies pay. The updated guide states, “applications submitted under the Clinical Trials Regulation are subject to a single fee which includes HPRA scientific and National Research Ethics Committee (NREC) ethical assessment.”
Companies will pay the fee to HPRA, which will then transfer a portion of the money to the NREC National Office “to cover the independent process of research ethics review by the NREC.” HPRA has also clarified that substantial amendments to authorized clinical trials can be submitted under the old clinical trial regulations until 21 January 2025.
Other changes include updates to the section on medical devices, another sector that is in the middle of a regulatory transformation. The updates include the addition of a statement that a discretionary waiver “will apply when a submission for assessment [under Article 59] is made on compassionate grounds for a single patient, single and multiple use of the same device.” Article 59 clears member states to allow the supply of medical devices that have not undergone conformity assessment in certain circumstances.
HPRA Guide
Dutch MEB changes device consultation rates after seeing costs deviate significantly from fees
The Dutch Medicines Evaluation Board (MEB) has changed its rates for medical device consultation procedures because the cost of the service deviated “significantly” from the revenues it generated.
For 2023, MEB has reset the rates for multiple forms of medical device consultation procedures considering the cost of providing the services. One fee has increased from €22,140 ($23,484) last year to €37,640 this year. MEB raised another medical device consultation fee from €14,060 to €21,090.
MEB adopted the targeted fee hikes alongside an across the board increase of 6%, a figure that reflects the “salary and price developments” faced by the regulator. The board also created a new fee for major changes in the use of a medicinal product in a medical device, thereby establishing different rates for type I and type II changes.
MEB Notice
EDQM seeks feedback on new and revised European Pharmacopoeia draft monographs
The European Directorate for the Quality of Medicines & HealthCare (EDQM) is seeking feedback on 80 draft European Pharmacopoeia (Ph. Eur.) monographs that are included in Pharmeuropa 35.1.
In the 80 new and updated monographs, EDQM presents new approaches to activities including the dissolution test for solid dosage forms, the characterization of powder behavior during compression and guidelines for using the test for bacterial endotoxins.
EDQM is accepting feedback on the drafts until 31 March. Comments made after the adoption of the text will be too late to be considered. Companies “may then be in a position where their product is not compliant with the Ph. Eur. monograph, which is a legal standard in Europe,” EDQM said, and “this could ultimately lead to a situation where a product can no longer be marketed in Europe.”
EDQM Notice


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