Swissmedic Scientific Advice: Guidance for Applicants and Marketing Authorisation Holders

Swissmedic has published guidance on MAGHP Scientific Advice, which explains how applicants can obtain scientific advice during the development of medicinal products intended for the Marketing Authorisation for Global Health Products (MAGHP) procedure. The guidance covers regulatory, quality, preclinical, clinical and pharmacovigilance topics. Version 2.0 is valid from 13 August 2026.

Purpose of MAGHP Scientific Advice

MAGHP scientific advice provides applicants with an opportunity to discuss specific technical questions before submitting a marketing authorisation application. Topics may include pharmaceutical quality, preclinical and clinical development, pharmacovigilance and risk management plans.

The World Health Organization (WHO) and selected National Regulatory Authorities (NRAs) may participate and provide their views. Scientific advice does not represent a decision on the future approval or assessment of the application.

Requesting a Scientific Advice Meeting

Applicants are encouraged to contact Swissmedic's Stakeholder Engagement Division (SHE) and Regulatory Assessment (RA) early when planning a meeting.

The formal request should be submitted at least 8 weeks before the proposed meeting date. It should include the application form, participating NRAs, information on WHO involvement, technical questions, draft agenda, proposed participants, meeting format and proposed dates.

Questions and Supporting Documents

Applicants must provide a focused list of technical questions together with relevant supporting documentation. The documents should directly support the questions and remain concise.

Normally, only submitted questions are discussed during the meeting. If significant changes occur before the meeting, Swissmedic must be informed. Revised questions and documents should be provided no later than 4 weeks before the meeting.

Meeting Preparation and Process

Swissmedic reviews the request and coordinates the meeting with relevant experts, NRAs and WHO. A meeting is generally scheduled approximately 8 weeks after receipt of the request.

The meeting may last up to 2 hours and is chaired by Swissmedic. It generally includes the applicant's presentation, expert opinions, discussion and agreement on next steps. The meeting is conducted in English.

If a question cannot be answered conclusively during the meeting, Swissmedic may provide a written opinion afterwards.

Meeting Minutes and Follow-Up

The applicant prepares the meeting minutes in English using the Swissmedic template. The minutes should record the meeting details, participants, opinions and agreed next steps.

Concerned NRAs and WHO have 2 weeks to provide comments. Swissmedic then consolidates the feedback and returns the revised minutes to the applicant.

The minutes represent the information available at the time of the meeting, while later developments may be considered during the future marketing authorisation assessment.

Fees

Swissmedic charges applicants for scientific advice meetings based on the administrative and scientific resources required. Fees are applied according to the FeeO-Swissmedic requirements.

What This Means for MAGHP Applicants

The MAGHP Scientific Advice procedure allows applicants to obtain regulatory and scientific input on important development questions before submitting their application.

Applicants should plan early, meet the 8-week submission requirement, prepare clear questions and supporting documents, and coordinate with Swissmedic, WHO and participating NRAs where applicable.

The guidance provides a defined framework for requesting, preparing, conducting and following up scientific advice meetings. Version 2.0 is valid from 13 August 2026.

References

• Swissmedic Guidance: MAGHP Scientific Advice, Identification Number ZL105_00_002, Version 2.0, valid from 13 August 2026.