Updating Swiss Regulatory Processes in 2024

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Swissmedic is the national authorization and supervisory authority for drugs and medical products in Switzerland whose primary objective is to assesses the quality, safety, and effectiveness of all medicinal products submitted for its approval. In January 2024, the agency announced updated guidance relating to APIs, temporary authorization, and fast-track authorizations.

Changes to the guidance document authorization of human medicinal product with known active pharmaceutical ingredients

In January 2024, Swissmedic announced that it was updating its guidance relating to APIs under the country’s Therapeutic Products Act (TPA). The rationale for updating the guidance on APIs was to reflect the agency’s thinking on how complex or heterogeneous APIs should be reviewed before being granted market access.

According to the agency, “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)” (1). However, the newly drafted text contains a caveat whereby the agency stipulates that additional documentation requirements may apply in such cases, “depending on the product group or the impossibility of complete chemical/physical characterisation” (1). To this end, the agency 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 are transferable (2). The guidance also requires that the authorization application must state the reasons for the type of application chosen (known API with or without innovation), and for the amount of data submitted.

The guidance document published by Swissmedic in January 2024 applies to the following types of authorization applications:

• for medicinal products for which the indication, pharmaceutical form, route of administration, and dosage recommendation are based on a reference product with the same API that is currently or has previously been authorized by Swissmedic
• for medicinal products with an indication, a pharmaceutical form, a route of administration, and/or a dosage recommendation that have not been or are not authorized to date for the reference products with the same API
• for variations relating to indication, pharmaceutical form, dosage strength, route of administration, and dosage recommendation for already authorized medicinal products with known APIs
• for medicinal product combinations consisting of several known APIs (3).

The guidance document does not, however, apply to:

• all extensions and variation applications not listed above
• the following medicinal products:
  1. advanced therapies based on gene transfer methods (gene therapy)
  2. biotechnological medicinal products
  3. blood products
  4. immunological medicinal products
  5. medicinal products containing genetically modified organisms (3).

Section 1.1.1. of the guidance document, Authorisation of Human Medicinal Products with Known Active Substance (No: ZL101_00_007, Version 5), has been adapted accordingly and section 5.10 “Requirements for medicinal products with a complex, heterogeneous structure” has been added (3).

Changes to the guidance document temporary authorization of human medicinal products

As part of its package of changes, Swissmedic also updated its guidance about the temporary authorization of medicinal products. At present, all criteria under Article 9a TPA in conjunction with Article 18-22 TPLO [Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Licensing of Therapeutic Products and the Licensing of Therapeutic Products by the Notification Procedure (SR 812.212.23)] must be met cumulatively for a temporary authorization to be granted (4). This applies at the point when an application for a temporary authorization is made and when the application for temporary authorization is subsequently received and completed.

According to Swissmedic’s guidance document, “It is possible for temporary authorisation to be granted under certain conditions defined by law to make medicinal products for the treatment of life-threatening diseases available to patients as quickly as possible” (5). Under these circumstances, the guidance document notes that the submitted clinical documentation, in particular, does not have to be complete for a temporary authorization request to be submitted, and the temporary authorization procedure has an accelerated deadline.

If temporary authorization is to be granted, however, the agency stipulates that one key criterion must be met by the applicant, which is to demonstrate that no authorized, alternative, and equivalent medicinal product is available in Switzerland (Article 9a para. 1 let. c TPA or Article 18 let. b TPLRO) (6). The sponsor is, therefore, obliged to provide details such as the indication, target population, mechanism of action, ease of use, and the risk-benefit profile of the product (2).

Under the provisions of the guidance document published by Swissmedic in January 2024, temporary authorization is possible in the following circumstances provided the criteria per Article 9a TPA in conjunction with Article 18 TPLO are fulfilled:

• new authorization of human medicinal products with new active substance (NAS).
• new authorization of human medicinal products with known active substance (KAS) if an indication not previously authorized is requested (KAS with innovation).
• additional indication for human medicinal products (5).

One of the benefits of the newly updated guidance is that the application process for seeking temporary authorization has been improved. According to Swissmedic, “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 … and 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 Article 18 TPLO are not met” (6). In this instance, the applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA) to request temporary authorization.

According to Swissmedic, the guidance document Temporary Authorisation for Human Medicinal Products has been amended accordingly in sections 5 and 6, along with Annexes 1 and 2, and is valid from 15 Jan. 2024 (5).

Changes to the guidance document fast-track authorization procedure

Also included in its package of updated guidance are streamlined procedures for implementing a fast-track authorization procedure (FTP). Swissmedic will employ differing processes in the future “based on the result of the assessment of the documentation submitted with the application for the implementation of an FTP” (7). In particular, the agency 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 Article 7 TPO [Therapeutic Products Ordinance Package] are not met” (7). In this instance, “the applicant will be given the option of submitting a written statement to Swissmedic or participating in an Accelerated Application Hearing (AAA)” (7).

In accordance with the new FTP guidance, the following criteria must all be met in line with Article 7 of the TPO for a human medicinal product (or any variations thereto), for a medicinal product to be evaluated using a fast-track authorization procedure:

• It is a promising prevention against, or treatment for, a severe, disabling, or life-threatening disease.
• Treatment using currently authorized medicinal products is either unavailable or unsatisfactory.
• A high therapeutic benefit is expected from using this new medicinal product (by demonstrating that the product works in the target population based on clinical studies, there is a high degree of proven effectiveness, and there is strong causality that the treatment works) (2,8).

The new guidance comes into force with immediate effect and forms part of a broad overhaul of guidance regarding multiple aspects of the drug development process and related regulatory processes.

References

1. Swissmedic. Changes to Guidance Document Authorisation of Human Medicinal Product with Known Active Pharmaceutical Ingredient. Swissmedic.ch, 15 Jan. 2024.
2. Al-Faruque, F. Swissmedic Updates Guidances on API, Fast-track Pathway, and More. Regulatory Focus. Regulatory Affairs Professionals Society (RAPS), 15 Jan. 2024.
3. Swissmedic. ZL101_00_007 Authorisation of Human Medicinal Products with Known Active Ingredients. Guidance Document, Version 5, 15 Jan. 2024.
4. Fedlex. SR 812.212.23 Ordinance of the Swiss Agency for Therapeutic Products of 22 June 2006 on the Simplified Licensing of Therapeutic Products and the Authorisation of Therapeutic Products by the Notification Procedure (TPLO). Guidance Document, 22 Jun. 2006.
5. Swissmedic. ZL 109_00_001 Temporary Authorisation for Human Medicinal Products. Guidance Document, Version 14, 15 Jan. 2024.
6. Swissmedic. Changes to the Guidance Document Temporary Authorisation of Human Medicinal Products. Swissmedic.ch, 15 Jan. 2024.
7. Swissmedic. Changes to the Guidance Document Fast-track Authorisation Procedure. Swissmedic.ch, 15 Jan. 2024.
8. Swissmedic. ZL 104_00_002 Fast-track Authorisation Procedure. Guidance Document, Version 10.0, 15 Jan. 2024.

About the author

Bianca Piachaud-Moustakis is lead writer at PharmaVision, Pharmavision.co.uk.

Article details

Pharmaceutical Technology Europe
Vol. 36, No. 3
March 2024
Pages: 7–8

Citation

When referring to this article, please cite it as Piachaud-Moustakis, B. Updating Swiss Regulatory Processes in 2024. Pharmaceutical Technology Europe, 2024, 36 (3), 7–8.