Swissmedic’s Guidance: Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings & Temporary Authorisations

Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact Packaging, Prior Notification Procedures, Fast-Track Authorisation, Regulatory Meetings, & Temporary Authorisations. These revisions are part of Swissmedic’s broader effort to streamline regulatory processes, increase transparency, and enhance collaboration with applicants.

Guidance: Packaging for Human Medicinal Products

• This document provides updated requirements for the packaging of human medicinal products to ensure compliance with safety and quality standards.

• Key Changes:

  • Enhanced labeling requirements to improve readability and accessibility for patients, including mandatory use of larger fonts and clearer symbols.

  • Additional safety features to prevent tampering and counterfeiting, aligned with international standards.

  • Updated environmental sustainability guidelines for packaging materials to promote eco-friendly practices.

• Impact: These updates aim to enhance patient safety, reduce medication errors, and support sustainable practices in pharmaceutical packaging.

Guidance: Procedure with Prior Notification

• This guidance outlines the process for submitting prior notifications to Swissmedic before making changes to authorized medicinal products.

• Key Updates:

  • Clearer timelines for notifying Swissmedic about changes, such as modifications to manufacturing processes or product specifications.

  • Expanded list of changes requiring prior notification, including certain packaging alterations and updates to risk management plans.

• Impact: The revised procedure ensures that Swissmedic is informed of critical changes in a timely manner, enabling faster regulatory decisions while maintaining product safety and efficacy.

Guidance: Fast-Track Authorization Procedure

• The fast-track authorization process is designed to expedite the approval of innovative medicines addressing unmet medical needs.

• Key Changes:

  • Streamlined submission requirements for fast-track applications, reducing administrative burden on applicants.

  • Introduction of a preliminary assessment phase to identify potential issues early in the review process.

  • Enhanced collaboration with applicants during the review process to resolve queries efficiently.

• Impact: These updates aim to accelerate patient access to groundbreaking therapies while maintaining rigorous safety and efficacy standards.

Guidance: Meetings with the Authorization Sector

• This guidance provides a framework for organizing meetings between applicants and Swissmedic’s authorization sector to discuss regulatory submissions and clarify requirements.

• Key Updates:

  • Standardized meeting types (e.g., pre-submission meetings, scientific advice meetings) with clear objectives and timelines.

  • Detailed instructions on how applicants can prepare for meetings, including required documentation and agenda-setting procedures.

• Impact: Improved communication between applicants and Swissmedic ensures smoother regulatory processes and reduces delays caused by misunderstandings or incomplete submissions.

Guidance: Temporary Authorization for Human Medicinal Products

• Temporary authorizations are granted for medicinal products addressing urgent public health needs when comprehensive data is not yet available.

• Key Updates:

  • Revised criteria for granting temporary authorizations, emphasizing evidence of significant therapeutic benefit over existing treatments.

  • Strengthened post-market surveillance requirements to monitor safety and efficacy during the temporary authorization period.

  • Clearer timelines for submitting additional data required to transition from temporary to full authorization status.

• Impact: These updates ensure that patients have timely access to critical therapies while maintaining robust oversight of product performance in real-world settings.

Whether you’re submitting a new application, requesting a fast-track review, or planning packaging changes, these documents provide essential clarity for compliance.

Regulatory and pharma professionals should review the updated guidances carefully and align internal procedures to reflect these changes.

All updated guidance documents are available on the Swissmedic website.