Masterarbeit

Implementation of TPO IV in Switzerland - implications for regulatory strategies and comparison with the European legislation ***

Dr. Christina Nöcker (2020)

Summary
Language: English
In Switzerland, the Swiss authority – Swissmedic – is responsible for the authorisation and supervision of medicinal products. As Switzerland is not a member of the European Union (EU) or of the European Economic Area (EEA), the participation in EU-marketing authorisation procedures is prohibited and the implementation of European directives in national law is not obligatory. In Switzerland, the use of medicinal products is regulated by the Therapeutic Products Act (TPA), which was adopted on December 15, 2000 and came into force on January 1, 2002. The first revision of the TPA was adopted on June 13, 2008 and came into effect on October 1, 2010 with the focus on achieving a better balance between the safety of medicinal products and the supply security.
The ordinary revision of the Therapeutic Products Act (stage 2) and the corresponding Therapeutic Products Ordinance Package IV (TPO IV) came into effect on January 1, 2019. The key aims of the TPA revision are facilitating market access of medicinal products by means of the implementation of new, simplified marketing authorisation procedures. Furthermore, the aim of the revision of the TPA is to improve drug safety (pharmacovigilance plan, good pharmacovigilance practices, increasing reporting obligations). Moreover, the transparency for the public should be increased with regard to published information regarding medicinal products (Swiss Public Assessment Report (SwissPAR)). More information should be available for patients concerning the composition of the medicinal product including all excipients (full declaration).
This master thesis focuses on implications for regulatory strategies for human medicinal products to be achieved by the implementation of TPO IV in Switzerland. New marketing authorisation procedures such as a temporary marketing authorisation (“befristete Zulassung”), marketing authorisation of biosimilars under Art. 13 TPA, simplified marketing authorisation procedures according to Art. 14 para. 1 let. abis-quater TPA are elucidated. Changes to the renewal procedure of marketing authorisations and the introduction of the paediatric investigation plan are illustrated. One key change of TPO IV is the harmonization with the EU variation system regarding Commission Regulation (EC) No 1234/2008 which is presented in this thesis. A comparison to EU legislation demonstrates that there are still differences compared to the Swiss legislation.
The implementation of TPO IV offers new possibilities for the pharmaceutical industry regarding new marketing authorisation procedures and there is evidence of advantages concerning the EU variation system. It definitely remains an interesting point to observe future development and adjustments which will follow in Switzerland.
Pages: 75