Euro Roundup: Swissmedic mandates nitrosamine risk assessments in some applications
The Swiss Agency for Therapeutic Products (Swissmedic) has updated guidance on nitrosamines to clarify when new authorization applications must include a risk assessment.Swissmedic added a section on nitrosamine risk assessments for active substances and finished products to its formal requirements guidance. The section features a table that lists compulsory requirements for active substances and finished products, plus exceptions to the rules.
Applicants must assess the risk of nitrosamines for “all new authorizations with chemical/synthetic active substances or active substances with synthetic components.” The rule does not apply to veterinary medicinal products, radiopharmaceuticals, and certain other situations.
Swissmedic has also mandated nitrosamine risk assessments for all new authorizations of finished products. All the active substance exceptions apply to finished products. Swissmedic has also exempted finished products such as complementary medicines and lozenges that come to market under the notification procedure.
The agency also updated a section of the guidance on parallel imports, requiring that one sample pack per dosage strength and/or flavor must be submitted directly to the Swissmedic laboratory.
Swissmedic updated another guidance document on parallel imports. The updates repeat the reduced sample pack requirements disclosed in the other document and clarify quality, safety, and efficacy rules. Importers may need to implement risk-minimizing measures if safety signals or quality defects relating to the original medicinal product are detected after market launch.
Swissmedic Notice, More
Targeted inspections of Swiss importers are planned to assess compliance
Swissmedic is launching another targeted inspection campaign to check if medical device importers are complying with their obligations.
Companies bringing products into Switzerland must verify product conformity, comply with the device’s storage and transport conditions, and inform authorities if there are complaints, incidents, and field safety corrective actions, including recalls.
The agency's campaign in 2023 revealed that full compliance with the obligations poses a challenge to many importers. Swissmedic found that 18 out of 30 importers performed incomplete product checks. Eight importers' storage and transport conditions were inadequate. Three importers had deficiencies in the recording and forwarding of complaints.
Swissmedic will check current compliance levels by selecting a random sample of Swiss importers for inspections. The agency will notify the medical device importers in writing of its intent to inspect their operations. Swissmedic’s notice to disclose the inspection campaign included links to information on importers' obligations.
Swissmedic Notice
EMA starts review of chikungunya vaccine, pauses use in seniors after reports of deaths
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) is reviewing the safety of Valneva’s live attenuated chikungunya vaccine Ixchiq.
PRAC has received reports of 17 serious adverse events, including two deaths, globally in people aged 62-89 years who received the vaccine. The committee is temporarily recommending restricting the use of the vaccine to people aged below 65 and pausing use in people of all ages with weakened immune systems. Most of the people who received Ixchiq in clinical trials were younger than 65.
The two deaths involved an 84-year-old man who developed encephalitis and a 77-year-old man with Parkinson's disease whose difficulty with swallowing worsened. Both deaths happened in the French overseas department of Réunion, which is vaccinating people in response to a chikungunya outbreak.
Ixchiq won approval in the EU in June 2024. EMA said around 43,400 doses of the vaccine have been used worldwide.
Press Release
Other news
The European Directorate for the Quality of Medicines and HealthCare (EDQM) has responded to a problem with mandatory compliance with EU M1 v3.1 and validation criteria v8.1 in electronic common technical document (eCTD) submissions. EDQM will temporarily accept submissions that do not comply with certain rules until a new version of the EU eCTD M1 package is issued. EDQM Notice
Medicines for Europe has called for Ukraine to change its laws on off-patent medicines to align with EU standards. The trade group, which represents generic and biosimilar companies, wants Ukraine to end patent linkage in all forms and drop plans to fine businesses over alleged patent infringement. Medicines for Europe has proposed the wording of changes to the draft law. Open Letter
ABPI has voiced disappointment with the free trade agreement between the UK and India. The UK pharma trade group said the deal “does not appear to address long-standing industry concerns about intellectual property protections.” Press Release
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