Switzerland: Swissmedic Revises Foreign Manufacturer GMP Requirements (w.e.f. 1 May 2025)

Swissmedic released an important amendment to its guidance document on Good Manufacturing Practice (GMP) compliance for foreign manufacturers, effective 1 May 2025. The update provides greater clarity around the submission requirements for audit reports and risk assessments, which are critical for new applications and changes related to human and veterinary medicinal products.

Key Highlights of the Amendment

1. Clearer Requirements for Document Submission

Whether you are submitting:

• A new authorization application

• A minor change (type IA/IAIN or IB)

• A major change (type II)

• Registering/modifying a veterinary medicinal product

  
  

Stakeholders are required to submit appropriate documentation that demonstrates GMP compliance by foreign manufacturers. The Responsible Person (RP) plays a crucial role in ensuring the documents meet Swissmedic’s expectations.

2. Audit Report Conditions and Expectations

Swissmedic outlines several key principles for submitting audit reports as proof of GMP compliance:

• Timing Matters: The final audit reports must be available at the time of submission. Pre-approval is not possible without it

• Re-Audits Are Acceptable: Reports from risk-based re-audits with a narrower scope are accepted, provided that all necessary GMP information is still documented, either directly or through an RP-prepared summary

• Redactions Must Not Impair Assessment: Any redacted audit reports or CAPA plans must still allow for a complete assessment of GMP compliance

• Three-Year Validity: Audit reports must be no older than three years and must cover the relevant active substance or finished product

  
  

3. Use of Reports from Recognized Authorities

If available, inspection reports from authorities whose GMP systems are recognized as equivalent by Switzerland can be used. However, they must:

• Be no older than three (3) years

• Be based on on-site inspections

• Cover the specific medicinal or finished product in question

  
  

Implications for Industry Stakeholders

This update reinforces Swissmedic’s commitment to maintain high standards while also offering flexibility in specific circumstances, such as:

• Recognizing risk-based re-audits

• Accepting well-supported risk assessments in place of full GMP certification for certain veterinary products

• Clarifying acceptable use of foreign inspection reports

  
  

Pharmaceutical companies, regulatory affairs professionals, and quality assurance teams must now ensure that all foreign manufacturer documents comply with these clarified requirements. Preparing in advance and aligning with the latest guidance can help avoid delays in product approvals and changes.

This amendment to Swissmedic’s GMP guidance aligns with global regulatory trends prioritizing transparency, consistency, and risk-based approaches. For stakeholders working with foreign manufacturers, now is the time to review existing documentation processes and engage with RPs to meet the revised requirements before they take full effect.

Source: Swissmedic