Swissmedic Updates Formal Requirements Guidance for Medicinal Product Authorisation Applications
Swissmedic has published Version 21.0 of its Formal Requirements guidance document, which sets out the administrative and documentation requirements applicable to medicinal product authorisation procedures in Switzerland.
The guidance covers a wide range of submission requirements, including dossier formats, application documentation, risk assessments, biosimilar applications and specific requirements for medicinal products used in combination with medical devices.
Requirements for Authorisation Applications
The guidance outlines the documentation expected for several types of authorisation procedures, including:
New active substances;
Medicinal products with known active substances;
Biosimilars;
Applications submitted under Article 13 of the Therapeutic Products Act (TPA).
For applications involving new active substances and biosimilars, Swissmedic requires applicants to provide information relating to clinical studies, pharmaceutical characteristics and manufacturing processes. Additional requirements are also specified for biosimilar comparability studies and the use of foreign comparator products.
Risk Assessment Requirements
Version 21.0 also includes requirements relating to nitrosamine risk assessments.
According to the guidance, risk assessments for nitrosamines in active substances and finished medicinal products are required for new authorisation applications, subject to certain specified exceptions.
Documentation and Submission Expectations
The document provides detailed requirements for CTD and eCTD submissions, including dossier structure, referencing practices and document organisation.
Swissmedic notes that references must be clearly traceable throughout the dossier and that incomplete or incorrect referencing may result in formal objections during the review process.
The guidance also includes requirements relating to responses to Swissmedic questions during ongoing application procedures and the submission of supporting documentation.
Requirements for Combination Products Incorporating Medical Devices
One section of the guidance addresses medicinal products used in combination with medical devices.
Swissmedic distinguishes between non-separable and separable combinations and sets out the documentation that may be required depending on the classification and conformity status of the medical device component.
The guidance refers to documentation such as:
CE declarations of conformity;
Certificates issued by conformity assessment bodies;
Notified Body Opinions under Article 117 of the MDR for certain devices without CE marking.
Swissmedic also states that the suitability of the medical device component for use with the specific medicinal product should be demonstrated as part of the submitted documentation.
Relevance for Medical Device and IVD Manufacturers
Although the guidance is primarily focused on medicinal product authorisation procedures, some sections are directly relevant to manufacturers involved in combination products.
Topics of potential interest include:
MDR Article 117 requirements;
CE conformity documentation;
Notified Body Opinions;
Combination product regulatory documentation;
Integration of medical device information within medicinal product dossiers.
For organisations developing drug-device combination products, the guidance provides further insight into Swissmedic’s expectations regarding the documentation and regulatory assessment of medical device components used alongside medicinal products.
