Thanks to research and technological progress, the number of new drugs and medical devices is increasing all the time. To ensure that the health of people and animals remains protected, the federal authorities regulate the use of therapeutic products.
The use of therapeutic products is regulated by the Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, TPA). It’s designed primarily to safeguard the health of humans and animals. Only high-quality, safe and effective therapeutic products can be put on the market in Switzerland. The law places particular emphasis on the following:
- User safety: Therapeutic products must be used in moderation and in accordance with their intended purpose.
- Product safety: Only high-quality, effective therapeutic products may be put on the market and used.
- Security of supply: A reliable and well-organised supply of therapeutic products, together with the necessary technical information and advice, is to be available throughout the country.
Therapeutic products include medicinal products and medical devices
Therapeutic products are used in the diagnosis, prevention or treatment of diseases, injuries and handicaps. A distinction is to be made between medicinal products and medical devices:
Medicinal products are products of chemical or biological origin which are intended to have or are presented as having a medicinal effect on the human or animal organism.
Medical devices are products which are intended to have or are presented as having a medical use and whose principal effect is not obtained with a medicinal product. They include instruments, apparatuses, in vitro diagnostics medical devices, software and other goods or substances.
Handling of the Therapeutic Products Act
We supervise the Therapeutic Products Act and the corresponding Federal Council ordinances. In the interests of patients we create a legal framework allowing the best possible use of high-quality, safe and effective therapeutic products. Important considerations are product safety, appropriate and moderate use of therapeutic products, and their availability.
The Therapeutic Products Act (TPA), in force since 1 January 2002, has basically proven itself in practice. In the meantime the law has been revised in two stages, and the relevant implementing provisions (Therapeutic Products Ordinance Package IV) are currently being amended.
Sustainable and impact-oriented development of therapeutic products legislation
Therapeutic products legislation is to be developed on an interdisciplinary, sustainable and impact-oriented level. Changing values in society, developments in science and technology as well as economic dynamics are all taken into account.
Last modification 30.10.2018