top of page
  • Writer's pictureMichael Zürcher

Swissmedic's 2023 report on human medicines: A leap forward in healthcare innovation

Swissmedic's 2023 annual report on the authorisation of human medicinal products with a new active substance and additional indications marks a pivotal year for healthcare innovation and regulatory efficiency in Switzerland. In this blog, we dive into the key aspects of the report, highlighting the advancements in medical treatments across various therapeutic areas and the regulatory strides made by Swissmedic.



New active substance approvals: fostering innovation

In 2023, Swissmedic approved 41 human medicines containing a new active substance. This achievement underscores the agency's commitment to facilitating access to innovative treatments. The approval process saw a reduction in median turnaround time to 441 days, a slight improvement from the previous year, reflecting Swissmedic's efforts to streamline its regulatory procedures without compromising on safety or efficacy standards.


Therapeutic advances: highlights across specialties

The report categorizes the newly approved medicines into several therapeutic areas, with oncology and hematological neoplasia leading the pack. This focus on cancer and blood disorders aligns with global health trends emphasizing the need for new treatments in these high-impact areas. Other notable categories include infectious diseases and vaccines; endocrinology and metabolism; and neurology and psychiatry, each representing significant strides in addressing complex health challenges.


Accelerated and standard review processes: balancing speed and rigor

Swissmedic employs both standard and accelerated review processes to balance the urgency of making groundbreaking treatments available with the imperative of thorough evaluation. The 2023 data reveals an adept use of these pathways, with a significant portion of approvals coming through accelerated processes. This underscores the agency's adaptability in responding to critical health needs.


Indication extensions: broadening treatment horizons

Beyond new active substances, Swissmedic also approved 65 additional indications, expanding the therapeutic use of existing medicines. This not only maximizes the utility of medicines but also offers patients new treatment options, illustrating the dynamic nature of medical science and the continuous evolution of healthcare solutions.



Swissmedic's 2023 achievements highlight a year of significant progress in the approval of new medicines and indication extensions. Through its efficient regulatory processes and commitment to healthcare innovation, Swissmedic plays a crucial role in advancing public health and paving the way for future therapeutic breakthroughs. The VIPS (association of pharmaceutical companies in Switzerland) also notes that biotech companies are increasingly using the international projects “Access Consortium” and “Project Orbis”.


If you are seeking to access the attractive Swiss market, Swizzard offers a range of services to help you realize your ambitions. Contact us to learn more about how we can help.





bottom of page