Switzerland Drug Registration: Swissmedic's Five Simplified Pathways

Switzerland Drug Registration is overseen by Swissmedic, the Swiss Agency for Therapeutic Products. . While the ordinary marketing authorisation procedure under Article 11 of the Therapeutic Products Act (TPA) applies to new active substances and typically takes around one year or longer depending on the review process and any requests for additional information, Switzerland also offers several simplified marketing authorisation routes. Selecting the appropriate pathway can significantly affect both the documentation required and the overall approval timeline.

Known Active Substance: The Most Commonly Used Simplified Route

Before looking at the statutory simplified authorisation categories under Article 14 TPA, it is helpful to distinguish another commonly used regulatory pathway: Known Active Substance (KAS) applications.

KAS applications apply to medicinal products containing an active substance that is already well established and, where appropriate, may rely on an authorised Swiss reference product together with published scientific literature and product-specific evidence instead of requiring the same level of supporting data expected for a completely new active substance.

KAS applications are commonly used for many generic and other established medicinal products. However, they are distinct from the simplified marketing authorisation categories established under Article 14 TPA, which are based on separate statutory eligibility criteria such as long-standing use, foreign authorisation history, cantonal authorisation, or specific categories of herbal medicinal products.

Five Distinct Simplified Pathways Under Article 14 TPA

· 10-year prior use in EU/EFTA (Art. 14 para. 1 let. abis): A medicinal product may qualify for simplified marketing authorisation where its active substance has been used in an authorised medicinal product for at least 10 years in an EU or EFTA country, provided the Swiss product is comparable to the foreign-authorised product with respect to its indication, dosage,pharmaceutical form, strength, and route of administration. Swissmedic still evaluates the product's quality, safety, and efficacy before granting authorisation.

· 30-year non-prescription use (Art. 14 para. 1 let. ater / 14a para. 1 let. b): Switzerland provides simplified pathways for medicinal products supported by long-standing medical use.

For certain non-prescription medicinal products, simplified authorisation may be available where the active substance has been used medicinally for at least 30 years, including 15 years within the EU or EFTA, and sufficient evidence exists regarding safety and efficacy.

Traditional herbal medicinal products follow a related but distinct pathway under Article 14 para. 1 let. cbis, recognising long-established traditional use where the statutory requirements are met.

· Herbal medicinal products with well-established or traditional use (Art. 14 para. 1 let. cbis): Herbal medicinal products follow a related but distinct pathway, recognising either well-established use (medical use in Switzerland or the EU/EFTA for at least 10 years) or long-established traditional use (at least 30 years of medicinal use, including 15 years within the EU or EFTA), where the statutory requirements are met.

· Cantonal authorisation (Art. 14 para. 1 let. aquater): Medicinal products that have held a cantonal marketing authorisation for at least 15 years within a Swiss canton may qualify for simplified authorisation at the federal level through Swissmedic.

· Co-marketing products: Co-marketing medicinal products may obtain marketing authorisation through a simplified notification-based procedure linked to an already authorised basic product. The applicant relies on the existing authorisation dossier of the basic product with the written consent of its marketing authorisation holder, in accordance with the applicable provisions of the Therapeutic Products Licensing Ordinance (TPLO).

Herbal Medicinal Products: Reduced Evidence Requirements

For eligible herbal medicinal products, Swissmedic may permit pharmacological, toxicological, and clinical study data—including studies in specific patient populations—to be replaced by appropriate bibliographic evidence demonstrating safety and efficacy.

For well-established use, the herbal active substance should generally have been used medicinally for at least 10 years in Switzerland or an EU/EFTA country.

For traditional-use herbal medicinal products, evidence of at least 30 years of medicinal use, including 15 years within the EU or EFTA, is generally required.

Traditional-use claims are limited to indications suitable for self-medication and may not require medical diagnosis, prescription, or physician-supervised treatment.

New Active Substances Continue to Follow the Ordinary Procedure

Switzerland Drug Registration for products containing new active substance (NAS)—whether chemical, biological, biotechnological, herbal, complementary, or radiopharmaceutical—that has not previously been authorised by Swissmedic must follow the ordinary marketing authorisation procedure under Article 11 TPA.

Likewise, products introducing genuinely new therapeutic indications, dosage forms, strengths, or routes of administration that fall outside the scope of the simplified pathways require full evaluation under the ordinary procedure.

Temporary Marketing Authorization (TempMA): Switzerland's Conditional Authorisation Equivalent

Under Article 9a TPA, Swissmedic may grant a Temporary Marketing Authorisation (TempMA) for medicinal products intended to treat life-threatening or seriously debilitating diseases where the statutory requirements are fulfilled.

Although broadly comparable to the European Union's conditional marketing authorisation, the Swiss TempMA framework has its own legal requirements and assessment criteria.

In certain circumstances, Swissmedic may determine during its scientific review that the conditions for a Temporary Marketing Authorisation are met, even where the applicant did not specifically request that pathway.

Parallel Import: A Specific, Conditioned Simplified Route

Companies wishing to parallel-import medicinal products into Switzerland can apply for a special marketing authorisation granted through a simplified procedure, provided: the product originates from a country with an equivalent authorisation system to Switzerland's, it satisfies the same requirements (particularly labelling and product information) as products already approved in Switzerland, and the parallel importer can meet the same safety and quality requirements as the Swiss marketing authorisation holder.

Notably, Swissmedic does not consider patent protection status when evaluating this — patent enforcement is left entirely to the patent holder, not factored into the regulatory decision.

Marketing Authorisation Validity and Fees

Swissmedic marketing authorisations are generally granted for an initial period of five years.

Before expiry, the marketing authorisation holder must apply for renewal. Following a successful renewal, the authorisation generally becomes valid for an unlimited period, unless Swissmedic determines that a further time-limited authorisation is necessary for public health reasons or under the conditions applicable to temporary marketing authorizations.

Application and examination fees vary depending on the type of submission and are established under the Swissmedic Fees Ordinance. Simplified marketing authorisation procedures generally attract lower fees than applications involving innovative medicinal products. Marketing authorisation holders are also subject to the applicable annual supervisory fees under Swiss legislation.

Biosimilars: Explicitly Excluded From the Simplified Pathway

Worth flagging clearly: the standard simplified marketing authorisation procedure does not apply to biosimilars. Swissmedic can grant exemptions from specific documentation and evidence requirements within a biosimilar authorisation procedure, but this is a different, more case-by-case mechanism than the broad simplified pathways available to small-molecule generics.

A Genuinely Distinctive Program: MAGHP

Worth knowing if your product addresses diseases disproportionately affecting low- and middle-income countries: Swissmedic operates the Marketing Authorisation Procedure for Global Health Products (MAGHP), building on the standard authorisation procedure but specifically inviting active participation from the National Regulatory Authorities of low- and middle-income countries (and WHO) in the assessment itself — aimed at building those authorities' own regulatory capacity while significantly reducing the timeline for getting essential medicines to patients in those markets. This program has actively issued real authorizations, including a pediatric antimalarial — worth investigating directly with Swissmedic if your portfolio includes products serving this specific access mission.

How OMC Medical Can Help

OMC Medical supports Switzerland Drug Registration by managing Swissmedic marketing authorisation across both the ordinary and the five distinct simplified Article 14 pathways, determines TempMA eligibility for products addressing life-threatening or debilitating diseases, and evaluates whether the MAGHP program applies for products serving low- and middle-income country health needs.