The latest revision of the Act and the newly proposed amendments to the implementing regulations are designed, in particular, to facilitate market access to medicinal products, improve drug safety and increase transparency.
The revised Therapeutic Products Act is due to enter into force at the beginning of 2019. What are the major changes? How are responsibilities regulated when it comes to therapeutic product safety? Which articles in the new TPA allow Swissmedic to publish more information than before? Will Swissmedic in future provide information about which companies have submitted authorisation applications and which authorisation applications were rejected? Information for the public: what cases will Swissmedic be able to provide information about in the future? Will Swissmedic make official authorisation decisions and evaluation reports available to the public? In the EU, medicinal products that are subject to additional supervision are marked with a black triangle. Does Switzerland intend to introduce something similar? Medicinal product packaging currently shows the company that distributes the medicine in question, but not the company that manufactures it. Is this due to change? How does Swissmedic intend to handle the transition in application submission and processing resulting from the change in the law (transition from current therapeutic products legislation to the new legal requirements of the revised TPA)?
Last modification 05.11.2018