Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Swissmedic Updates Guidance on Orphan Drugs, Pediatric Investigation Plans
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its guidance on orphan drugs and pediatric investigation plans (PIPs). The revisions address topics, including orphan drug fees and the documentation to supply in support of European and American PIPs.
Swissmedic’s changes to the orphan drug guidance center on three sections. A new section on rare disease indication extensions is among the more substantive changes. If a medicine has orphan drug status in one rare disease, Swissmedic will allow its use in another rare disease under the same name and authorization number. If the new disease does not meet the orphan drug criteria, the medicine will either lose its status or be sold under a different name and number in the new indication.
The reverse is true when a company wants to expand use of an approved drug without orphan drug status into a rare disease. Swissmedic will make manufacturers sell the drug for the rare disease under a different name and authorization number.
Swissmedic also outlined the process for transferring orphan drug status to another company and added a section stating that it will waive the flat-rate fees for applications of medicines with orphan drug status.
The changes were released alongside revisions to multiple documents related to PIPs. Swissmedic’s changes to the PIP guidance addressed the documents that companies must submit in relation to investigation plans newly produced for Switzerland and those already prepared for authorities in the United States or elsewhere in Europe.
Swissmedic accepts PIPs approved by the European Medicines Agency (EMA) and equivalent plans cleared by the US Food and Drug Administration, provided the same indications and dosage forms are covered in each territory. The Swiss agency reserves the right to ask questions and request further documents from applicants that use PIPs approved overseas.
The conditions of fulfillment differ depending on whether a PIP is specific to Switzerland or not. In the case of Swiss PIPs, Swissmedic expects companies to file results within 60 days of the creation of the final study report.
, PIP Guidance
Denmark Creates Brexit Guidance for Medical Device Manufacturers
The Danish Medicines Agency (DKMA) has released guidance to help medical device manufacturers cope with a no-deal Brexit. DKMA set out its position, which is in line with Europe-wide advice, in a frequently asked question document.
DKMA’s guide is broken up into sections covering questions relevant to manufacturers, importers, authorized representatives and other groups. Each section addresses potential scenarios that could arise if the UK leaves the European Union without a deal.
In its advice for manufacturers, DKMA details what will happen to devices previously certified by UK notified bodies after Brexit, clarifies that companies will not need to re-label products and explains the situation facing businesses whose notified bodies are still setting up an office in the EU when the UK leaves.
Another section runs through the process for seeking exemptions to the ban on the sale of non-CE marked medical devices. The answers follow the European position but explain how that applies to Denmark. For example, DKMA stated it “will pay particular attention to whether the healthcare professional/hospital states that the device is necessary for patient treatment” when assessing whether to grant an exemption.
DKMA published the document in the run up to another cliff edge in the UK’s attempt to leave the EU in a way that mitigates the impact on people and businesses across the region. The original delay to Brexit gave the UK until 12 April to pass the withdrawal agreement to avoid leaving without a deal. With that deadline fast approaching, the UK secured a further extension until the end of October this week.
EMA Enters Into Information-Sharing Agreement With EU Quality Body
Leaders at EMA have entered into an information-sharing pact with their counterparts at a drug quality body. The agreement positions EMA to work with the European Directorate for the Quality of Medicines and Healthcare (EDQM) on regulatory tasks.
EMA and EDQM have worked together for years. EDQM staff participate in EMA committees and working groups, and EMA contributes expertise to the European Pharmacopoeia Commission and other activities involving EDQM.
The revised agreement positions the organizations to work more closely together on quality-related issues, including anti-counterfeiting. Specifically, the new pact enables EMA and EDQM to share commercially confidential information, personal data and pre-decisional information, such as reports from inspections of manufacturing facilities and post-approval surveillance activities. The agreement covers drugs and active ingredients for use in human and veterinary medicine.
Guido Rasi, executive director of EMA, detailed the terms of the agreement in a letter to the director of EDQM. In addition to discussing what information will be shared and why, Rasi set out restrictions on the distribution of confidential reports. EMA and EDQM will only distribute shared information to people within their organizations who need to see it and are bound by confidentiality agreements.
Swissmedic Finds Insufficient Evidence to Ban Breast Implants
Swissmedic has opted against banning macro-textured and polyurethane-coated breast implants at this time. The Swiss agency evaluated the evidence after its French counterpart suspended sales of the devices but found insufficient evidence to support regulatory action at this stage.
Links between products including Allergan’s Biocell and breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) have spurred regulatory investigations around the world, culminating last week in France’s National Agency for the Safety of Medicines and Health Products (ANSM) and Health Canada prohibiting the sale of Biocell.
Swissmedic has reached a different conclusion. Responding to the ANSM action, Swissmedic released a statement that it “will not implement the French measures ... due to the lack of evidence on the cause and underlying mechanism of BIA-ALCL.” Swissmedic also cited the “lack of scientific evidence showing a causal connection between the use of a particular breast implant and the development of BIA-ALCL” to justify its decision.
To date, Swissmedic has learned of four cases of BIA-ALCL in Switzerland. Swissmedic thinks the causal link between Biocell and those cases is lacking and is recommending patients discuss the benefits and risks with their physicians.
The agency said such discussions are particularly important in light of comments made by BIA-ALCL interest groups at recent hearings in France and the United States. The interest groups argued that physicians are failing to adequately explain the risks to patients.
, Regulatory Focus
has refined the deadline for the submission of answers to its lists of questions related to applications in the fast-track authorization procedure. Applicants previously had to submit answers at least 40 days before the Human Medicines Expert Committee meeting. Now, Swissmedic has asked for responses to be filed 37 to 43 days before the meeting. Swissmedic thinks narrowing the window for submissions will help it promptly process applications on its fast track. Swissmedic Notice
is moving some medicines from the pharmacy-only category C. The agency will publish a summary of the reallocation actions from the end of May and update it every month. Swissmedic is making the changes in response to the government’s decision to eliminate category C. Most drugs in the category are being downclassified, but Swissmedic will make it harder to access around 15% of the affected medicines. Most of the upclassified medicines are opioid derivatives. Swissmedic Notice