Swizzard Pharma AG

Gladly sharing a summary of our H1/2024 posts on Switzerland’s market attractiveness, as well as key market access, regulatory, and quality-related topics. If you want to learn more, contact me please. Happy reading!

We’ve just wrapped up the first seven months of our series on navigating the Swiss healthcare market, where we explored the regulatory landscape, key reasons for market attractiveness, and critical quality standards. If you’re looking to expand into Switzerland, understanding the intricacies of Swissmedic and approval pathways is essential. Stay tuned for upcoming insights into marketing strategies in rare disease drugs, digital health, and personalized medicine! https://lnkd.in/d8DmChaZ #SwizzardPharma #SwissHealthcareLandscape #MarketingServices Michael Zürcher, PhD EMBA Bettina Schelbert Karin Senn

In our Swizzard Champions series, we interview experienced thought leaders from the world of pharma, biotech and healthcare and share valuable industry insights. Today, we talk to Katharina Oehler, CEO of pharma services oehler gmbh, about exploring the benefits of the #AccessConsortium for Swiss medicinal products. Download the full interview here: https://lnkd.in/dEF4E33p #ACCESSConsortium #MarketAccess #SwizzardPharma #PharmaServicesOehler Michael Zürcher, PhD EMBA Bettina Schelbert Karin Senn

This August, the Swizzard team gathered for our fourth annual summer garden party—a perfect mix of relaxation and celebration as we raised our glasses to an outstanding first half of the year. 🥂   #SwizzardPharma #SwizzardTeam #SummerParty Michael Zürcher, PhD EMBA | Bettina Schelbert | Yves Heller | Joël Heller | Bruno Zimmermann | Jonas Mülchi | Karin Senn | David Hoffmann, MSc, MBA, LLM

Understanding Regulatory & Access Pathways for Rare Disease Drugs in Switzerland Navigating the Swiss regulatory landscape for rare disease drugs requires a thorough understanding of the available pathways and strategic planning. Our latest blog post provides an in-depth analysis of these pathways and the strategic considerations necessary for successfully bringing innovative medicines to the Swiss market. Key Highlights: - Detailed overview of Swissmedic's pathways: Standard, Fast-track, Temporary, Prior-notification, and Article 13 TPA approvals. - Importance of Orphan Disease Designation (ODD) for accelerated approvals and financial advantages. - Strategic early dialogues and market access considerations with the Federal Office of Public Health (FOPH) to ensure timely reimbursement. The strategic pathway for rare disease drugs in Switzerland, therefore, involves a combination of regulatory savvy, proactive engagement with authorities, and a deep understanding of the unique market access landscape. Aligned effectively, these elements can contribute significantly to the successful introduction and uptake of rare disease therapies in the Swiss market. Read our expert blog on this topic and other key aspects of navigating the Swiss healthcare landscape by clicking the link below: https://lnkd.in/dcBumn9C #RareDisease #RegulatoryPathways #AccessPathways Michael Zürcher, PhD EMBA | Bettina Schelbert | Karin Senn

Celebrating our 25th client partnership! Exciting news from Swizzard—we’ve just welcomed our 25th client! Over the last 3.5 years, we’ve had the privilege of working with innovative biotech and pharma companies, guiding them through market entry, market access and commercialization strategies to bring their breakthrough products to Switzerland. We are immensely grateful for the trust our clients place in us and for the opportunity to contribute to advances in healthcare. Our commitment remains unwavering: to deliver strategic insights that ensure our clients’ success and broaden the impact of their innovations on patient care across Switzerland. Thank you to each of our partners for joining us on this remarkable journey. We look forward to continuing our mission and celebrating more successes together! #SwizzardPharma #Biotech #MarketEntrySwitzerland #MarketAccessSwitzerland https://lnkd.in/dJU4i-DF Michael Zürcher, PhD EMBA | Bettina Schelbert | Karin Senn

Meeting quality and Swiss standards in pharmaceutical production and distribution The Swiss pharmaceutical industry, a powerhouse of the country’s economy, generates 5% of GDP and 50% of annual exports. Known for its high quality standards, it ensures patient safety and drug reliability, reinforcing Switzerland’s global reputation. Swissmedic, the regulatory authority, oversees the entire life cycle of medicinal products, enforcing Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP). Companies must obtain a pharmaceutical establishment license (PEL) to operate legally, ensuring compliance. A robust quality management system (QMS) and a designated responsible person (RP) are essential for maintaining supply chain integrity. Adhering to Swissmedic regulations and international standards is crucial for global distribution and competitiveness. Compliance with Swiss regulations enhances product integrity, operational efficiency and market access while mitigating risks. This commitment ensures Switzerland’s respected position in the global market and the reliability of its pharmaceutical products. Read the whole article on our webpage: https://lnkd.in/e5Ubj3Qx For assistance with Swiss pharmaceutical regulations, contact Swizzard Pharma AG! https://lnkd.in/esRhTVqW #SwissPharma #RegulatoryInsights #MarketEntrySuccess Michael Zürcher, PhD EMBA | Joël Heller | Bettina Schelbert | Mathieu Bitz | Luc Heller | Yves Heller | Julia Mühlethaler | Arne Holicki | Bruno Zimmermann | Jonas Mülchi | Karin Senn | David Hoffmann, MSc, MBA, LLM

Swissmedic's 2023 report on human medicines: a leap forward in healthcare innovation Swissmedic's 2023 report reveals a significant year for healthcare innovation: 41 new active substances and 65 additional indications were approved, enhancing treatment options across various diseases. The median review time was reduced to 441 days, highlighting efficiency in regulatory processes. Key areas include oncology, infectious diseases and neurology. The international approval projects #AccessConsortium and #ProjectOrbis are increasingly being used for accelerated approval alternatives. This year's progress underscores Switzerland's commitment to advancing public health through timely access to innovative treatments. Dive into our extended analysis on Swissmedic’s 2023 approvals by visiting our blog: https://lnkd.in/dzSuCRD8 #SwizzardPharma #HealthcareInnovation #Swissmedic2023 #Pharmaceuticals Michael Zürcher, PhD EMBA Bettina Schelbert Karin Senn Mathieu Bitz Yves Heller Joël Heller Luc Heller Julia Mühlethaler Arne Holicki

Navigating the Swiss landscape: Main regulations and standards that foreign companies need to be aware of   Foreign biotech and pharmaceutical companies wishing to enter the Swiss market must operate within a comprehensive regulatory and reimbursement framework, which is mainly overseen by the Swiss Agency for Therapeutic Products (Swissmedic) and the Federal Office of Public Health FOPH. Knowledge of the main regulations and standards is essential for successful market entry and operation.   Want to enter the Swiss pharmaceutical market? Here's an overview of the regulatory and reimbursement aspects:   → Prerequisites and licences: Foreign companies considering Switzerland need a solid understanding of the regulatory intricacies and oversight by Swissmedic. Obtaining a Pharmaceutical Establishment Licence (PEL) and becoming a Marketing Authorisation Holder (MAH) are key milestones.    → Authorisation routes: Explore pathways such as Article 13 TPA, Access Consortium, ORBIS and Promise Pilot for different scenarios, from standard reviews to accelerated procedures for breakthrough therapies. Swizzard Insight No. 1 provides a comprehensive overview.   → Reimbursement landscape: Inclusion on the Specialty List (SL) managed by the Federal Office of Public Health (FOPH) is key to reimbursement. Liaise with the FOPH on pricing procedures after Swissmedic approval. See our Insight No. 6 for more details.   → Streamlined processes: To streamline Swissmedic and FOPH applications, the new early submission procedure facilitates simultaneous marketing authorisation and reimbursement for essential medicines.   → Case-by-case reimbursement: Switzerland's unique provisions allow for the reimbursement of non-compliant or unlisted medicines, thanks to Article 71a-d of the Health Insurance Act.   → Swizzard support Success in Switzerland requires regulatory and reimbursement expertise. Need more insight into entering the Swiss market? Get in touch - and let's navigate your way together! https://lnkd.in/dr8UxHMD #SwissPharma #RegulatoryInsights #MarketEntrySuccess Michael Zürcher, PhD EMBA | Bettina Schelbert | Karin Senn | Yves Heller

Our CEO, Michael Zürcher, will be attending the Swiss Biotech Day. The conference is hosted by the Swiss Biotech Association, of which Swizzard is also a member. "Swizzard looks forward to partnering with biotechs and pioneer commercialization solutions in the Swiss healthcare landscape."   #SwizzardPharma #SwissBiotechDay #SwissBiotechAssociation