Regulatory Blog

Swissmedic has issued two guidance documents that provide important regulatory requirements for companies holding medicinal-product authorisations or establishment licences in Switzerland. One guidance covers renewal, discontinuation, and changes between the main authorisation and the export licence, while the other describes the process for Scientific GMDP Meetings with Swissmedic. Together, these guidances provide a structured framework for managing authorisation-related ac

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 oppor

As pharmacovigilance systems continue to move toward standardized electronic reporting, efficient and reliable exchange of Individual Case Safety Reports (ICSRs) is essential for the timely management of adverse drug reaction information. Swissmedic has established an electronic exchange process based on the ICH E2B(R3) standard for the transmission of ICSRs between Marketing Authorisation Holders (MAHs) and Swissmedic. The Guidance for Industry on the Electronic Exchange of

Switzerland's regulatory framework for medicinal products and medical devices places strong emphasis on product quality, effective market oversight, and the safe conduct of clinical investigations. Recent Swissmedic information sheets provide important requirements for pharmaceutical companies, medical device manufacturers, sponsors, investigators, and other stakeholders operating in Switzerland. This blog provides a concise overview of three Swissmedic information sheets cov

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

This guidance , " Guidance on Controlled Substances Company Meetings " , issued by Swissmedic and valid from 06 March 2026, outlines the framework for Controlled Substances Company Meetings. These meetings are designed to support companies handling controlled substances or involved in the cultivation of cannabis for medical purposes, enabling efficient interaction with Swissmedic’s Narcotics Division. Background Companies dealing with controlled substances must comply with st

In February 2026, Swissmedic published updated guidance documents covering key regulatory and post-authorisation requirements for human medicinal products. These updates provide clarity on administrative changes, pharmacovigilance obligations, formal submission requirements, packaging standards, document protection, parallel import procedures, co-marketing authorisations, lifecycle management, and variations. Guidance: Change of Name or Domicile of the Authorisation Holder Th

On 1 September 2025 , Swissmedic published a set of updated guidance documents that refine requirements for medicinal product...

On 18 August 2025, Swissmedic published Version 2.3 of its guidance on the " Submission Process for Clinical Trials with Medicinal...

The efficient international supply of medical devices depends not only on innovation but on robust regulatory processes that certify...

As the Swiss life sciences sector grows increasingly global and collaborative, Switzerland’s regulatory authority, Swissmedic , continues...

On June 2, 2025 , Swissmedic published a harmonised suite of guidance documents to standardise, streamline, and digitalise the clinical...

Switzerland’s regulatory landscape for pharmaceuticals continues to evolve, balancing patient safety with market efficiency. Two pivotal...

Swissmedic, the Swiss Agency for Therapeutic Products, has released multiple updated guidance documents in April 2025 that impact...

The Swiss Agency for Therapeutic Products (Swissmedic) has introduced updated guidance on " Export Certificates " effective 19 March...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance, " Renewal, Discontinuation, and Status Change of...

The Swiss Agency for Therapeutic Products (Swissmedic) has released an updated guidance" Submission of Periodic Safety Update Reports...

Swissmedic has published an updated guidance for" Orphan Drug " aimed at streamlining the regulatory process for medicinal products...

Swissmedic, the Swiss Agency for Therapeutic Products, has recently updated its guidance documents for " Parallel Import " and "...

The Swissmedic released (31 October, 2024) updated guidance on " Clinical Investigations with Medical Devices " and " Performance studies...