Snapshot

The Swissmedic Article 13 Therapeutic Product Act (TPA) pathway has been developed by the Swissmedic of Switzerland.

This pathway can be used where At the request of the applicant, the assessment according to Art. 13 TPA will be applied to all authorisation applications for medicinal products with known active substances and biosimilars, and also to its applications for extensions or variations according to section 6, provided that these satisfy the conditions stated in Art. 16 - 20 TPO. .

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

When relevant, the agency relies on prior decisions from Australia Canada EEU Eurasia Economic Union EU-EMA Japan New Zealand Singapore United Kingdom United States

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