Current Publications Relevant to the GDP Area

In recent weeks, several new publications and position papers have been released that have implications for the GDP area and the management of pharmaceutical supply chains. Below, you will find a concise overview.

Revision of Annex 15

The European Medicines Agency (EMA) has published a concept paper on the revision of Annex 15 (Qualification and Validation) of the EU GMP Guide.

Planned changes include, among others:

• Extension of the scope to active substance manufacturers
• Stronger integration of Quality Risk Management (ICH Q9 (R1))
• More explicit requirements for transport verification and supplier qualification

A two-month public consultation period is scheduled until April 2026. The final draft is expected by the end of 2026.

We have summarised further details in a separate news article.

Swissmedic

Swissmedic has specified its expectations for companies engaged in international trade in medicinal products with Version 4.0 of Interpretation I-SMI.TI.18e (Legal requirements and mandatory due diligence by Swiss firms wishing to engage in foreign trade with medicinal products or ATMPs from Switzerland, and on supply chain traceability if products are imported for re-export).

Key GDP-related aspects include:

• Import for the purpose of re-export is considered a regular import activity
• Full application of GDP requirements in import/re-export scenarios
• Complete supply chain traceability
• Risk-based supplier qualification

A more detailed summary of the document and the implemented changes is available here.

In addition, document I-SMI.RL.02e (Description, harmonisation and steering of the Swiss GMP/GDP inspection system for medicinal products) has been published in a new version; however, no GDP-relevant changes have been introduced.

EU Pharma Package

Internal EU coordination indicates that parts of the new EU Pharmaceutical Package will become applicable earlier than publicly communicated. The “Union List of Critical Medicines” is expected to apply from the date of entry into force, with further provisions on security of supply to follow six months later.

Further details are available here.