Swissmedic reinforces Switzerland’s role in global regulatory collaboration and advanced therapeutics

Swissmedic, Switzerland’s national regulatory authority for therapeutic products, has strengthened its role in the global healthcare landscape through strategic collaborations and innovations in regulatory science. From cross-border initiatives to advances in digital transformation, Swissmedic is positioning itself as a leader in efficient, high-quality regulatory processes, providing Swiss patients with safe and timely access to cutting-edge therapies.

The content of this article is based on insights from an interview with Raimund Bruhin, Executive Director of Swissmedic, as published in PharmaBoardroom.

Swissmedic, Switzerland’s national regulatory authority for therapeutic products, has a vital mandate to ensure the safety, quality, and efficacy of medicines, vaccines, and medical devices throughout the country. According to Swissmedic Director Raimund Bruhin, the agency’s core responsibilities include the authorization, approval, and surveillance of medicinal products, as well as the market surveillance of medical devices in Switzerland. Unlike other regulatory authorities, Swissmedic does not deal with the procurement, pricing or reimbursement of medicines, as these tasks fall within the remit of the Federal Office of Public Health (FOPH). Swissmedic also enforces criminal law relating to therapeutic products and represents cases in court up to the federal level.

Pandemic lessons and adaptations

The COVID-19 pandemic presented a unique set of challenges to regulatory authorities worldwide, including Swissmedic, which played a critical role in the Swiss response. The pandemic underscored the importance of rapid communication and international cooperation, particularly through organizations such as the International Coalition of Medicines Regulatory Authorities (ICMRA). In response to the public health crisis, Swissmedic adopted flexible regulatory processes and introduced the Rolling Submission approach, which allowed the agency to prioritize and expedite assessments during the crisis. This approach, says Bruhin, enabled Swissmedic to be one of the first three authorities in the world to approve mRNA vaccines.

Internally, Swissmedic optimized its crisis management by establishing task forces that reallocated resources to pandemic-related activities, ensuring continued performance in both crisis management and day-to-day regulatory tasks.

Global cooperation and the Access Consortium

Swissmedic’s participation in the Access Consortium, an international regulatory collaboration founded in 2007, exemplifies the agency’s commitment to cross-border cooperation. The consortium, which includes regulatory authorities from Switzerland, Canada, Australia, Singapore, and the United Kingdom, accelerates the approval of medicines by establishing a shared regulatory foundation and enabling collaborative work-sharing among member countries. Through this initiative, Swissmedic has strengthened its ability to process innovative medicines by leveraging the expertise of its partner authorities.

The Access Consortium not only streamlines drug approvals but also introduces enhanced flexibility for companies that select Switzerland as their primary approval market. For these firms, the consortium offers significant time savings and access to a broad market of over 150 million potential patients. The introduction of the “Promise” pathway within the consortium further optimizes approval times, signaling Swissmedic’s commitment to efficiency in regulatory processes.

Orbis initiative and accelerated cancer drug approvals

Another important aspect of Swissmedic’s international work is its participation in the Orbis Initiative, a program that facilitates the parallel approval of cancer drugs through close cooperation with the U.S. Food and Drug Administration (FDA). According to Swissmedic, this collaboration enables faster, synchronized drug approvals that bring life-saving cancer treatments to patients more quickly. While resource-intensive, the Orbis initiative underscores Swissmedic’s emphasis on global partnerships to accelerate access to innovative therapies.

Participation in global health and regulatory capacity-building for the Global South

Swissmedic also makes its regulatory expertise available to developing countries, primarily through the Marketing Authorization for Global Health Products (MAGHP) initiative. This program supports low- and middle-income countries by sharing Swissmedic’s regulatory experience and inviting partner authorities to participate in the evaluation of essential medicines. Through MAGHP, Swissmedic actively promotes international standards in pharmaceutical regulation and aims to support the establishment of strong regulatory frameworks in the Global South. In collaboration with the World Health Organization (WHO) since 2014, Swissmedic plays a crucial role in improving access to essential medicines and in developing the regulatory infrastructure of emerging health systems.

Swissmedic’s assistance in establishing an African Medicines Agency (AMA) demonstrates its broader commitment to capacity-building. The AMA, modeled after the European Medicines Agency (EMA), aims to provide African countries with a robust regulatory system that meets global standards for safety and quality in therapeutic products.

Strategic focus on Advanced Therapy Medicinal Products (ATMP)

As the field of innovative therapies expands, Swissmedic has established a specialized division for Advanced Therapy Medicinal Products (ATMP). This area includes complex products such as cell and gene therapies, CAR-T cell treatments, mRNA-based vaccines and tissue engineering, all of which pose new regulatory challenges. By developing specialized expertise in ATMP, Swissmedic aims to address the regulatory complexities of these treatments and ensure that Swiss patients have timely access to breakthrough medical advances.

Goals for digital transformation and regulatory harmonization

In line with its long-term vision, Swissmedic is driving its digital transformation to streamline regulatory processes and improve collaboration with global partners. The recent launch of a cloud-based medical device database in August 2024 is an important step towards Swissmedic’s goal of becoming a digitally advanced regulatory authority. This technological shift not only increases operational efficiency, but also strengthens Swissmedic’s interoperability with other regulatory bodies, making it more responsive to the needs of the pharmaceutical industry.

Harmonization with global regulatory standards remains a cornerstone of Swissmedic’s strategic objectives. Through active participation in international initiatives such as the International Council for Harmonization (ICH) and the International Medical Device Regulators Forum (IMDRF), Swissmedic works to shape evidence-based regulatory processes and contribute to global regulatory frameworks. These collaborations support the Swiss healthcare industry and promote regulatory alignment that benefits patients and industry stakeholders alike.

Positioning Swissmedic for the future

Looking ahead, Swissmedic’s strategic goals for 2023 to 2026 underscore its mission to protect human and animal health by ensuring the quality, safety, and efficacy of therapeutic products. Through its regulatory expertise, global partnerships, and commitment to digital transformation, Swissmedic remains a trusted authority both in Switzerland and internationally. Swissmedic’s proactive approach to regulatory challenges – from digital modernization to ATMP oversight – signals its commitment to maintaining high standards in healthcare while fostering innovation and expanding access to life-saving treatments.

By prioritizing these objectives, Swissmedic aims to position Switzerland as a leader in regulatory science and a hub for groundbreaking medical innovation, in keeping with the country’s strong reputation in the global life sciences and healthcare sectors.