Switzerland Swissmedic's Guide to Project Orbis, Orphan Drug Framework, and Packaging Requirements
- Sharan Murugan
- 11 hours ago
- 4 min read
Bringing innovative medicines to patients requires more than scientific excellence. Pharmaceutical companies must navigate complex regulatory pathways, demonstrate product quality, ensure appropriate labeling, and comply with country-specific requirements before a medicinal product reaches the market.
Swissmedic, Switzerland's national authority for therapeutic products, has established several regulatory mechanisms that facilitate patient access to innovative therapies while maintaining high standards for quality, safety, and efficacy. Among these mechanisms are Project Orbis, which supports international collaboration in oncology drug reviews, the Orphan Drug framework, which encourages the development of treatments for rare diseases, and comprehensive packaging and labeling requirements designed to ensure safe and effective use of medicinal products.
Cancer remains one of the most significant healthcare challenges worldwide. To facilitate faster access to promising oncology treatments, Swissmedic participates in Project Orbis, an international initiative coordinated by the U.S. Food and Drug Administration (FDA). The program enables concurrent submission and review of oncology products among participating regulatory authorities, allowing innovative therapies to reach patients more quickly.
Project Orbis currently involves regulatory agencies from multiple countries, including Switzerland, Australia, Canada, Singapore, Israel, Brazil, and the United Kingdom. While the FDA coordinates the review process, each participating authority retains full independence regarding final approval decisions and product labeling requirements.
Objectives of Project Orbis
The primary goals of Project Orbis include:
Accelerating access to innovative oncology medicines.
Enhancing collaboration among global health authorities.
Facilitating simultaneous regulatory reviews.
Reducing duplication of scientific assessments.
Supporting efficient use of regulatory resources.
Types of Project Orbis Submissions
Swissmedic classifies Project Orbis applications into three categories:
Type A
Applications submitted to Swissmedic within 30 days of FDA submission qualify as Type A. These submissions benefit from the highest level of international collaboration and parallel assessment, resulting in shorter review timelines.
Type B
Applications submitted more than 30 days after FDA submission, but before FDA approval, are classified as Type B. Depending on review status and available resources, they may receive expedited assessment.
Type C
Applications submitted after FDA approval are considered Type C. While FDA assessment reports may be shared, concurrent review is no longer possible, and standard review timelines apply.
Benefits for Sponsors
For pharmaceutical companies developing oncology products, Project Orbis offers:
Earlier patient access to innovative treatments.
Enhanced regulatory alignment.
Increased transparency during assessment.
Opportunities for scientific dialogue among authorities.
Potential reduction in overall global submission timelines.
Developing treatments for rare diseases presents unique scientific and commercial challenges. Small patient populations often make clinical development more difficult and economically challenging.
To address these challenges, Swissmedic provides an Orphan Drug Status (ODS) framework for medicinal products intended to diagnose, prevent, or treat rare diseases.
What Qualifies as an Orphan Drug?
A medicinal product may qualify for orphan status if it is intended to treat a life-threatening or chronically debilitating disease affecting no more than five individuals per 10,000 people in Switzerland. Alternatively, orphan designation may be granted if the product has already received orphan recognition in a country with a comparable regulatory system.
Advantages of Orphan Drug Status
Medicinal products granted orphan status may benefit from:
Access to simplified authorization procedures.
Priority review during regulatory assessment.
Reduced regulatory fees.
Enhanced support for products targeting unmet medical needs.
Application Strategy
Sponsors may submit orphan designation requests:
Before marketing authorization applications.
Simultaneously with authorization applications.
After authorization has been granted.
Because orphan designation reviews are generally completed faster than marketing authorization reviews, designation is often obtained before final product approval. For products already recognized as orphan drugs abroad, Swissmedic may leverage foreign regulatory decisions while still requiring supporting documentation and evidence demonstrating the equivalence of the medicinal product.
Even the most innovative medicine can present risks if packaging and labeling are unclear, incomplete, or misleading. For this reason, Swissmedic maintains detailed requirements governing the design and content of packaging for human medicinal products.
Core Packaging Principles
Swissmedic requires that packaging:
Supports medication safety.
Avoids misleading information.
Prevents inappropriate use.
Communicates essential product information clearly.
Maintains readability and consistency.
All packaging text must generally be presented in at least two official Swiss languages (German, French, or Italian), although specific exceptions exist for products intended exclusively for hospital use.
Primary Packaging Requirements
Primary packaging must typically include: Product name. Batch number. Expiry date.
Additional information such as active substances, dosage strength, route of administration, storage instructions, warnings, and marketing authorization holder information may also be required depending on product characteristics.
Secondary Packaging Requirements
Outer cartons generally contain a more comprehensive set of information, including:
Product name. Active ingredients. Dosage strength. Dosage form. Route of administration. Quantity of dosage units. Storage conditions. Child safety warnings. Authorization number. Batch and expiry details. Swissmedic licensing symbols.
Packaging Design Considerations
Swissmedic emphasizes readability and product differentiation.
Acceptable design elements include:
Tall-man lettering to reduce medication errors.
Distinctive fonts and colors.
Braille product names.
Multilingual product names where appropriate.
At the same time, promotional claims, unnecessary logos, and misleading statements are generally prohibited.
Focus on Patient Safety
The packaging guidance demonstrates Swissmedic's commitment to reducing medication errors through the standardized presentation of critical information. Requirements for active substance display, dosage strength visibility, storage instructions, and warning statements all contribute to safer medicine use across healthcare settings.
References
Swissmedic Guidance Document: Project Orbis
Swissmedic Guidance Document: Orphan Drug
Swissmedic Guidance Document: Packaging for Human Medicinal Products
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