Swissmedic, the Swiss Agency for Therapeutic Products, is responsible for ensuring that only high-quality, safe, and effective medical products are available in Switzerland. To streamline regulatory processes and enhance transparency, Swissmedic has issued several key guidances (01 June, 2024) covering variations, temporary authorization, meetings for applicants, and time limits for authorization.
Variations refer to any changes made to the terms of a marketing authorization after it has been granted. These changes can affect the quality, safety, or efficacy of a medicinal product.
Extension typically refers to the process of extending the marketing authorization of a medicinal product to include new indications, formulations, dosages, routes of administration, or other changes that significantly differ from the original approval.
This guidance document explains the requirements pertaining to variations and extensions for human medicinal products. Switzerland recognises the following application types, depending on the possible implications for quality, safety and efficacy:
Minor variations to be reported subsequently, type IA/IAIN
Minor variations to be reported in advance, type IB
Major variations, type II
Extensions
The categorization of the variations can be found in Annex 7 TPLRO. If a variation does not appear in the list, it can be submitted as an "Other change".
Temporary authorization allows for the early availability of medicinal products in exceptional circumstances, such as public health emergencies or when a product addresses an unmet medical need. The authorisation of a medicinal product is based on full documentation and results either from an ordinary procedure according to Art. 11 TPA or after conversion of a temporary authorisation to an authorisation without special
conditions (Art. 21 a para. 2 TPLO).
Eligibility Criteria:
The product must demonstrate a favorable risk-benefit profile.
There should be no alternative treatments available.
The applicant must commit to completing additional studies to confirm the product's efficacy and safety.
For detailed information, refer to the full guidance document.
Meetings for applicants are formal interactions between Swissmedic and applicants to discuss regulatory requirements, application strategies, and specific issues related to the development and authorization of medicinal products. This guidance describes the meeting for applicants in the authorisation procedure, stipulates the documentation to be submitted, the preparation of the advice (decision on the form of implementation, communication and planning before the meeting, if applicable the implementation of the advice in the form of a meeting, the subsequent processing and archiving and the fee levied.
Types of Meetings:
Scientific Advice Meeting in the development phase of a medicinal product
Pipeline Meeting
Presubmission Meeting prior to submission of an authorisation application
LoQ Clarification Meeting with a view to producing a prompt, correct and complete response to the List of Questions (LoQ), particularly if major objections exist.
Labelling Meeting (swissmedic request)
Time limits for authorization refer to the specified timeframes within which Swissmedic must review and make a decision on marketing authorization applications.
This guidance describes the timetable for authorisation procedures and defines the time limits observed by Swissmedic (SMC) in connection with submitted authorisation applications. Legal provisions are in existence for certain time limits (e.g. appeal deadlines).
Comments