FDA Inspection as GMP Evidence? Swissmedic Opens Up a New Option

Swissmedic has revised its guidance document "GMP compliance by foreign manufacturers " and published Version 7.0. The new version has been in force since 7 September 2026. The document explains how foreign manufacturers' GMP compliance must be demonstrated as part of marketing authorisation applications and variation procedures, and which documents may be submitted to Swissmedic for this purpose.

One significant change concerns manufacturers that have been inspected by the U.S. Food and Drug Administration (FDA). The revised guidance contains two new sections covering these cases; one for active substance manufacturers and one for finished medicinal product manufacturers. Under certain conditions, GMP compliance may now be demonstrated by submitting an FDA inspection report or selected documents issued by the FDA.

Swissmedic specifically lists the following as possible forms of evidence:

• an FDA inspection report;
• a valid Certificate of Pharmaceutical Product (CPP),
• an FDA cGMP Declaration or a valid cGMP Certificate.

However, these documents do not automatically replace any further assessment. The decisive factor is whether the relevant evidence is current and adequately covers the manufacturer concerned, the manufacturing site, the scope of activities and, where applicable, the relevant product or active substance. The documents must therefore be reviewed in the context of the specific procedure to determine whether they meet Swissmedic's requirements.

In addition, Version 7.0 clarifies the requirements for GMP certificates. It also supplements and clarifies the provisions governing the use of inspection reports issued by foreign authorities whose GMP control systems are recognised by Switzerland as equivalent. This makes it clearer which inspection documents may be used as evidence and what information they must contain.

Further amendments concern the documents that must be submitted and the permitted document languages.

Companies should therefore check, when preparing new marketing authorisation applications and variation procedures, whether their existing GMP evidence still meets the requirements of the revised guidance. This is particularly important where compliance is demonstrated on the basis of an FDA inspection or a document issued by the FDA.