Euro Roundup: Swissmedic updates responsible person document, asks for immediate action
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its technical interpretation of the requirements for responsible persons. Swissmedic said the “license holder is generally required to adapt immediately” when an update renders their old approach noncompliant with Swissmedic’s new position.Switzerland’s Medicinal Products Licensing Ordinance covers the requirements for a responsible person. Swissmedic created the technical interpretation to describe how Swiss inspectorates interpret the rules. As such, companies can use the document to help assess whether an individual meets the requirements for applying to Swissmedic to act as a responsible person.
Version 7.0 features “numerous clarifications,” Swissmedic said. Most of the changes affect a chapter that describes the qualifications individuals need to be a responsible person. Swissmedic has clarified the education and experience in good distribution and manufacturing practices that are required, including by stating that “brokerage, agents, trade in foreign countries-activities do not count as GDP experience.”
The agency also removed “the experience with regulatory issues as acceptable criterium” and clarified the experience needed in areas with specific risks. Individuals must have at least one year of experience “in an environment that has addressed the risk or peculiarity in question,” Swissmedic said. Examples of products with specific risks include sterile medicinal products.
Swissmedic added a new section on remote technical and market release, explaining that the approach could be accepted under certain circumstances. The agency named the part of the ordinance that the release must comply with and provided restrictions on the acceptability of the practice.
“The remote release must take place within the residence of the [responsible person], in Switzerland, where, should the need arise, an inspection could be carried out. Moreover, compliance to the points listed in the EMA publication questions and answers on remote batch certification/confirmation by the qualified person apply mutatis mutandis,” Swissmedic said.
For the inspectorates, the updated technical interpretation applies with immediate effect. That is mostly true for companies, too. Swissmedic highlighted one exception to the need for immediate compliance.
The exception covers a section on the need for the responsible person to be “proficient enough in at least one of the Swiss national languages in order to be able to read, understand and interpret laws, ordinances, etc. without intermediaries.” Swissmedic expects responsible persons to speak one of the official local languages of the canton where the inspection takes place and where the site is located.
License holders with approved responsible persons who do not meet the requirements have 12 months to comply. Swissmedic has provided the transition period to allow companies to “make the necessary adjustments, either by appointing a new responsible person with the required language skills or by ensuring that the responsible person acquires the required language skills within this period.”
Swissmedic Notice
France’s ANSM publishes paper on myocarditis attributed to COVID-19 vaccines
The French National Agency for Medicines and Health Products Safety (ANSM) has published a paper on the safety of COVID-19 mRNA vaccines in JAMA. The paper looks at the long-term prognosis of patients with myocarditis attributed to COVID-19 mRNA vaccines, SARS-CoV-2 infection and other causes.
Myocarditis, the medical term for inflammation of the heart muscle, is rare in recipients of vaccines such as Moderna’s Spikevax and Pfizer’s Comirnaty but there is evidence of a causal association. Other people develop the condition after being infected with SARS-CoV-2, the virus the vaccines protect against, or for reasons unrelated to COVID-19.
AMSM researchers looked at French healthcare databases to understand whether clinical outcomes and medical management differ depending on the cause of myocarditis. The study of 4,635 people found individuals with post-vaccine myocarditis had better outcomes than their counterparts.
“Patients with post–COVID-19 mRNA vaccination myocarditis, contrary to those with post–COVID-19 myocarditis, show a lower frequency of cardiovascular complications than those with conventional myocarditis at 18 months,” the researchers said. “However, affected patients, mainly healthy young men, may require medical management up to several months after hospital discharge.”
ANSM Paper
NICE rules benefits of Alzheimer’s drug Leqembi are too small to justify the cost
The UK National Institute for Health and Care Excellence (NICE) has concluded that Eisai’s Alzheimer’s disease drug Leqembi's benefits are too small to justify the cost to the healthcare service.
Eisai received Medicines and Healthcare products Regulatory Agency (MHRA) approval for Leqembi, an antibody that hits amyloid beta, in Great Britain last week. MHRA said the medicine has shown “some evidence of efficacy in slowing progression of the disease.” Coupled to the safety and tolerability data, the evidence of efficacy was enough to support authorization in the UK.
NICE has different criteria, though. The committee found that Leqembi slows the progression from mild to moderate Alzheimer’s by four to six months. The price Eisai wants to charge in the UK is confidential but NICE found the drug, which costs $26,500 a year in the US, has insufficient efficacy to warrant the outlay.
A lack of evidence in key areas complicated the analysis. NICE noted uncertainty about Eisai’s model and the long-term effects of the treatment. Eisai told NICE the full long-term benefits of Leqembi may not be apparent at 18 months. The company published three-year results in July but NICE’s draft consultation makes no mention of the longer-term data. NICE is accepting feedback on the draft until 20 September.
NICE Notice, MHRA Statement
Danish Medicines Agency calls for companies to seek approval of critical drugs
The Danish Medicines Agency (DKMA) has asked companies to apply for marketing authorization for two critical medicines to ensure the supply of the products in Denmark.
DKMA is seeking applications for approval of small packs of 5mg prolonged-release morphine tablets and metronidazole in a 40mg/ml oral solution. The agency said it “may utilize various regulatory options that could make it particularly attractive to seek marketing authorization for the medicine in Denmark.” DKMA will assess which regulatory options to apply on a case-by-case basis.
The call for applications covering the two drugs marks the start of a wider project. DKMA plans to ask companies to seek approvals when there are no other marketed alternatives and when it is aware that a particular medicine is being removed from the Danish market. The agency may also use the initiative for “medicines with high clinical demand where no marketed medicines cover the therapeutic need.”
DKMA Notice
EU updates Clinical Trials Regulation Q&A, adding question on interim analyses
The European Union has updated a question-and-answer document on the Clinical Trials Regulation, adding a new query about intermediate data analysis and revising several existing sections.
In answer to the new question, the Clinical Trials Coordination and Advisory Group explains that sponsors should submit a summary of intermediate data within one year of performing the analysis. There are exceptions. Sponsors do not need to submit summaries when they or the investigators are blinded to the data, when the protocol has clear criteria for continuing the trial, and when there are justified reasons.
The coordination group also updated the document considering the revised Clinical Trials Information System transparency rules and provided new information on changing the principal investigator and on pediatric trial results.
EU Q&A
Other news:
Swissmedic has updated a warning about the presence of synthetic drugs in supposedly herbal products. The agency made the post after seeing “an increasing number of supposedly herbal teas, herbal capsules and natural liquid concentrates” sold for weight loss and to treat erectile dysfunction. Swissmedic has found drugs such as the appetite suppressant sibutramine in the products. Swissmedic Notice
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