Swissmedic Publishes New Guidance on Scientific GMDP Meetings for Establishment Licence Holders
On 6 January 2026, Swissmedic will implement a new Guidance Document on Scientific GMDP Meetings (ID: I-321.AA.01-A05e), aimed at companies that hold — or are applying for — a Swiss establishment licence.
This guidance formalises the process for Scientific GMDP Meetings, which are structured discussions between Swissmedic and industry stakeholders to address Good Manufacturing and Distribution Practice (GMDP) issues at an early project stage. These meetings offer an opportunity for companies to seek clarification on regulatory expectations before implementation or inspection, especially in relation to major changes or innovation-driven projects.
Key Objectives of the Guidance
The goal is to support companies in identifying and addressing potential GMDP compliance concerns early, particularly when undertaking activities such as:
New construction or modification of production buildings, facilities, systems, or supply chains;
Introduction of innovative technologies, including:
Continuous manufacturing
Robotic filling lines
Rapid microbiological methods
AI-driven or computer-assisted systems
Launch of new manufacturing processes, product classes, or gene therapy/ATMP manufacturing;
Projects involving major changes that are notifiable under Article 41 of the MPLO (Medicinal Products Licensing Ordinance).
Scientific GMDP Meetings do not serve as advisory sessions, but allow Swissmedic to comment on project-related questions and provide feedback that companies can factor into their decision-making and implementation plans.
Eligibility and Application Process
Companies may request a meeting if they:
Hold a valid Swiss establishment licence;
Are applying for a new licence or amendment;
Are preparing to submit (or have submitted) a major change notification.
Applications must be submitted 6 to 8 weeks prior to the desired meeting date using the designated form, and must include:
Contact and licence details;
Clear, focused questions to be addressed;
Preferred meeting dates and format (on-site or virtual);
Supporting documentation such as an agenda, company presentation, and list of participants.
Optional background documents may also be submitted to support Swissmedic's review.
Meeting Format and Follow-up
Meetings may take place in person at Swissmedic or via video conference, and typically last 1.5 to 2 hours. The applicant is responsible for:
Preparing and presenting the relevant issues;
Taking official minutes using Swissmedic’s template;
Submitting the minutes in Word format within two weeks of the meeting.
Swissmedic will review, revise if needed, and confirm the final version, which becomes part of the official project record.
Fees
Swissmedic will charge a fee for these meetings based on the scientific and administrative work involved, in accordance with the Swissmedic Fees Ordinance (FeeO-Swissmedic, SR 812.214.5).
This new guidance reflects Swissmedic’s commitment to early engagement with licence holders, improving regulatory predictability and facilitating compliance in increasingly complex manufacturing environments.
You can download the full guidance document below.
