Legal & Regulatory > Switzerland > Data Requirements

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1. In addition to the clinical data obtained through clinical studies please list the data required for:

a. Market approval

According to Art. 11 TPA, an application for marketing authorisation must contain all of the essential data and documents for its assessment, which are in particular:

• Name of the medicinal product;
• Name of the manufacturer and the distributor;
• Manufacturing process, composition, quality and stability of the medicinal product;

In addition, all the clinical data obtained in clinical studies must be provided, especially:

• Results of physical, chemical, pharmaceutical and biological or microbiological tests;
• Results of pharmacological and toxicological tests and clinical trials, including all results from trials in specific population groups;
• Therapeutic effects and undesirable effects;
• Labelling, information supplied about the medicinal product and the dispensing method as well as the method of administration;
• Assessment of the risks and, if necessary, a plan for their systematic recording, investigation and prevention (pharmacovigilance plan);
• Pediatric investigation plan

b. Pricing Decisions

For the details and the data of the pricing decision process, see above chapter IV. In addition, the following data is required for the evaluation of the external and internal referencing prices.

For the ERP, the authorization holder must provide the FOPH with the relevant price, in principle the ex-factory price, of the reference countries. To this effect, a confirmation of the price by the authorization holders of the reference countries, a government authority or an association must be enclosed (Art. 34c para. 1 OBHI).

For the IRP, the authorization holder must provide the FOPH with all data used for the comparison between the product under review and the similar medicinal products until February 15 of the review year (Art. 34f para. 2 OBHI).

c. Reimbursement Decisions

In order to be reimbursable, medicinal products and services must be included in the LS. According to Art. 30a OHCS, a request to the FOPH for inclusion of an original drug on the LS must basically include the following documents and confirmations:

• Expert Information on the drug;
• Market authorization decision by Swissmedic (or at least a pre-notification by Swissmedic on the upcoming decision to grant authorization);
• Key Facts, i.e., facts on dosage, scientific studies regarding efficacy, pricing etc.;
• ERP documents;
• Clinical overview;
• Three most important peer-reviewed clinical studies on the medicinal product;
• Epidemiological data from Switzerland on the illness to be treated with the medicinal product.