The table below details changes to five guidance documents (listed in column 1 below) for the authorisation of human medicinal products.
| Updated guidance document Document (plus form where applicable) | What the document concerns | Changes to the document | Sections of the document updated | When do the changes take effect/become applicable? |
|---|---|---|---|---|
| Guidance document Authorisation of human medicinal product with known active substance | This guidance document is valid for the simplified authorisation of human medicines with known APIs in accordance with Art. 14, para. 1 a, TPA. This guidance document applies to the specific application types listed in the document. | Medicinal products whose known chemical active pharmaceutical ingredient has a complex, heterogeneous structure (or with a formulation of this active pharmaceutical ingredient that is complex and heterogeneous) may be deemed to be medicinal products with a known active pharmaceutical ingredient (known API, with or without innovation). However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterisation. For example, additional data may be required on pharmacodynamics, pharmacokinetics or toxicity in order to prove that the reference medicinal product’s safety and/or efficacy data are transferable. The authorisation application must state the reasons for the type of application chosen (known API with or without innovation) and for the amount of data submitted. If there is any uncertainty as to the product-specific documentation requirements, Swissmedic strongly recommends that the issues in question be clarified at a meeting for applicants held prior to the submission (cf. guidance document Meeting for applicants held with the Authorisation sector). | Section 1.1 (supplemented) and section 5.10 (new) – additional information regarding medicinal products where the known active pharmaceutical ingredient (or the formulation of the known active pharmaceutical ingredient) has a complex, heterogenous structure) HMV4 suffix removed Editorial changes | 15 January 2024 |
| Guidance document Temporary authorisation for human medicinal products | It is possible for temporary authorisation to be granted under certain conditions defined by law in order to make medicinal products for the treatment of life-threatening diseases available to patients as quickly as possible. The submitted clinical documentation in particular does not have to be complete for a temporary authorisation (temp.auth) and the temporary authorisation procedure has an accelerated deadline. In contrast to the standard procedure, temporary authorisation must first be requested and this process may only be used if the request has been approved. An application for temp.auth/temp.AI cannot be submitted until the request has been approved. If authorisation is requested for a medicinal product or an additional indication using the standard procedure, but Swissmedic considers the data submitted to be insufficient, Swissmedic may propose an “ex officio” temporary authorisation to the applicant provided the criteria per Art. 9a TPA in conjunction with Art. 18 TPLO are fulfilled. | One key criterion to be met is that there is no authorised, alternative and equivalent medicinal product available in Switzerland (Art. 9a para. 1 let. c TPA or Art. 18 let. b TPLRO). The criteria for assessing the equivalence of medicinal products include the indication, the target population to be treated, the mechanism of action, the ease of use, and the risk-benefit profile. In addition, the process for applying for a temporary authorisation has been optimised. Differing processes will be employed in future, based on the result of the assessment of the documentation submitted with the application for a temporary authorisation procedure. In particular, Swissmedic will now issue a preliminary decision to reject the application for a temporary authorisation procedure if the assessment reveals that the criteria specified in Art. 18 TPLO are not met. The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA). | Section 5.2 – Criterion b (Art. 18 TPLO): Clarification of the criteria for checking the equivalence of medicinal products Section 6: Clarification regarding the times when the criteria for the temporary authorisation must be fulfilled according to Art. 9a TPA and Art. 18 TPLO (specifically: on receipt and completion of the application and when an extension is requested by the applicant). Process optimisations for the request for temp.auth. or temp.AI | 15 January 2024 |
| Guidance document Fast-track authorisation procedure | A fast-track procedure (FTP) is possible for the authorisation of a medicinal product, provided that the criteria stated in Art. 7 TPO are cumulatively fulfilled. Therefore, in contrast with the standard procedure, in all cases the FTP requires a previously approved request for the implementation of this procedure. An application for an FTP cannot be submitted until the request has been approved. | The process for applying for the implementation of an FTP has been optimised. Differing processes will be employed in future based on the result of the assessment of the documentation submitted with the application for the implementation of an FTP. In particular, Swissmedic will now issue a preliminary decision to reject the application for the implementation of an FTP if the assessment reveals that the criteria specified in Art. 7 TPO are not met. The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA). Additionally, criterion c – A high therapeutic benefit is expected from using this new medicinal product – has been explained in more detail. | Optimisation of the FTP application procedure | 15 January 2024 |
| Guidance document Authorisation human medicinal product under Art. 13 TPA and Form Information for application Art.13 TPA | If an applicant requests the authorisation, extension or a variation of an authorisation for a medicinal product or procedure1 for which authorisation has already been granted in a country with a comparable control system for medicinal products, Swissmedic will take into consideration the results of the assessments carried out by the foreign regulatory agency provided that certain requirements are fulfilled. A reduced assessment in accordance with Art. 13 TPA for an application for authorisation or variation of a medicinal product is possible, provided that the documentation requirements according to Art. 16 TPO are fulfilled. | Swissmedic has amended the guidance document to include the stipulation that the indication wording for the medicinal product for which an authorisation or indication extension is being applied for must be identical to the indication wording approved by the foreign reference authority. Conditions imposed by the reference authority that have not yet been fulfilled by the time of the authorisation decision by Swissmedic are usually also imposed by Swissmedic. Applications for exemption from the conditions imposed by the foreign reference authority and also ordered by Swissmedic may now only be submitted to Swissmedic once the reference authority’s decision is known. Other amendments to the guidance document include clarifications relating to the submission of RMPs and RMP updates. | Clarifications regarding eCTD applications in section 5.1 Clarifications regarding consistency of foreign and Swiss documentation in sections 5.1, 5.7 and 11.1 Clarification in section 5.2 regarding RUP procedure Clarification regarding medicinal product information for reference products that are no longer authorised in section 5.5 Clarification regarding submission of documentation in section 5.10 Clarification of the wording “indication” and “indication wording” in sections 6.1 and 7.1 Clarification regarding RMP HMV4 suffix deleted, further editorial changes | 15 January 2024 |
| Guidance document Authorisation in accordance with Art. 14para.1 abis-quater TPA | Swissmedic maintains its practice in respect of dispensing categories and classifies products in dispensing categories based on the current criteria. This means that the dispensing category may differ from that of the foreign comparator medicinal product. T | The practice was previously described in the “Questions and Answers” document and has now been included in section 5.1.7 of the guidance document. The terms “foreign comparator medicinal product” and “foreign reference medicinal product” have been included in the definitions (section 1.1) and used consistently throughout the document. Based on the accumulated experience, Swissmedic has clarified the information regarding the requirements for the application documentation for authorisations according to Art. 14 para. 1 let. abis TPA (section 5.2.2). The table in Annex 1 has been added to provide an overview of the differences between the foreign reference medicinal product, the foreign comparator medicinal product and the medicinal product that is the subject of the application in Switzerland. There have also been some changes to wording and some further explanations have been added regarding the content, but these do not involve any new requirements for the applicant. | Section 5.1.7 “Dispensing category classification” added Clarifications in section 5.2.2 “Application documentation requirements” Information added to section 1.1 “Definitions” New Annex 1 added | 15 January 2024 |