Swissmedic updates guidances on API, fast-track pathway, and more
Regulatory News | 15 January 2024 |
(Source: iStock)
Swissmedic has made updates to several of guidances related to active pharmaceutical ingredients (API), temporary authorization, products that receive fast-track authorization, and other documents how it authorizes products under the Therapeutic Products Act (TPA).
The agency said it updated its guidance on APIs to reflect its thinking on how complex or heterogenous APIs are reviewed before being allowed on the market.
“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),” said Swissmedic. “However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterization.”
Swissmedic updated its definition of what can be acceptable as a known active ingredient (KAS) in the guidance to include complex APIs and its requirements for such products. The agency said it may require sponsors to provide additional documentation on the product's pharmacodynamics, pharmacokinetics, and toxicity to prove that the safety and efficacy data from the reference medicinal product can be used to assess the API.
“The authorization application must state the reasons for the type of application chosen (KAS with or without innovation) and for the amount of data submitted,” the regulator added. “If there is any uncertainty as to the product-specific documentation requirements, Swissmedic strongly recommends that the issue in question be clarified at a meeting for applicants held prior to the submission (cf. guidance document Meeting for applicants held with the Authorization sector).”
Swissmedic also updated its guidance on temporary authorization of medicinal products under its regulatory regime. In order to qualify for temporary authorization, the agency noted that an alternative authorized product can’t already be available in Switzerland, and the sponsor has to provide details such as the indication, target population, mechanism of action, ease of use, and risk-benefit profile of the product.
Swissmedic said it had improved the application process that sponsors can use to ask for temporary authorization of their product.
“Differing processes will be employed in future, based on the result of the assessment of the documentation submitted with the application for a temporary authorization procedure,” the agency added. “In particular, Swissmedic will now issue a preliminary decision to reject the application for a temporary authorization procedure if the assessment reveals that the criteria specified in Art. 18 TPLO are not met.”
The agency said sponsors can now also ask for an Accelerated Application Hearing (AAA) to request temporary authorization.
Additionally, Swissmedic said it has streamlined its guidance on its fast-track authorization procedure (FTP). The agency said it will use different processes for assessing products for FTP depending on the results of the documentation that sponsors submit.
“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,” said the agency. “The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA).”
The agency further clarified how it determines whether a product has proven high therapeutic benefit to warrant FTP designation, which includes proving the product works in the target population based on clinical studies, proving high effect size, and showing strong causality that the treatment works.
Under the Therapeutic Products Act, Swissmedic can allow certain medical products on the market whose active substance has already been authorized by the European Union or by a country that is part of the European Free Trade Agreement (EFTA) for at least 10 years.
Based on the experience the regulator has gathered, it has updated its TPA guidance on the definition of "foreign comparator medicinal product" and "foreign reference medicinal product." More specifically, it clarified 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.
Swissmedic has also updated documentation requirements for products that are allowed on the market under TPA.
The agency said it updated its guidance on APIs to reflect its thinking on how complex or heterogenous APIs are reviewed before being allowed on the market.
“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),” said Swissmedic. “However, additional documentation requirements may apply in such cases, depending on the product group or the impossibility of complete chemical/physical characterization.”
Swissmedic updated its definition of what can be acceptable as a known active ingredient (KAS) in the guidance to include complex APIs and its requirements for such products. The agency said it may require sponsors to provide additional documentation on the product's pharmacodynamics, pharmacokinetics, and toxicity to prove that the safety and efficacy data from the reference medicinal product can be used to assess the API.
“The authorization application must state the reasons for the type of application chosen (KAS with or without innovation) and for the amount of data submitted,” the regulator added. “If there is any uncertainty as to the product-specific documentation requirements, Swissmedic strongly recommends that the issue in question be clarified at a meeting for applicants held prior to the submission (cf. guidance document Meeting for applicants held with the Authorization sector).”
Swissmedic also updated its guidance on temporary authorization of medicinal products under its regulatory regime. In order to qualify for temporary authorization, the agency noted that an alternative authorized product can’t already be available in Switzerland, and the sponsor has to provide details such as the indication, target population, mechanism of action, ease of use, and risk-benefit profile of the product.
Swissmedic said it had improved the application process that sponsors can use to ask for temporary authorization of their product.
“Differing processes will be employed in future, based on the result of the assessment of the documentation submitted with the application for a temporary authorization procedure,” the agency added. “In particular, Swissmedic will now issue a preliminary decision to reject the application for a temporary authorization procedure if the assessment reveals that the criteria specified in Art. 18 TPLO are not met.”
The agency said sponsors can now also ask for an Accelerated Application Hearing (AAA) to request temporary authorization.
Additionally, Swissmedic said it has streamlined its guidance on its fast-track authorization procedure (FTP). The agency said it will use different processes for assessing products for FTP depending on the results of the documentation that sponsors submit.
“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,” said the agency. “The applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA).”
The agency further clarified how it determines whether a product has proven high therapeutic benefit to warrant FTP designation, which includes proving the product works in the target population based on clinical studies, proving high effect size, and showing strong causality that the treatment works.
Under the Therapeutic Products Act, Swissmedic can allow certain medical products on the market whose active substance has already been authorized by the European Union or by a country that is part of the European Free Trade Agreement (EFTA) for at least 10 years.
Based on the experience the regulator has gathered, it has updated its TPA guidance on the definition of "foreign comparator medicinal product" and "foreign reference medicinal product." More specifically, it clarified 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.
Swissmedic has also updated documentation requirements for products that are allowed on the market under TPA.
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