Concept Paper on revision of EU & PIC/S GMP Annex 6

Date

February 12, 2026

Category

EU Regulations

Description

On 11 February the EMA and PIC/S jointly issued a Concept Paper proposing to revise GMP Annex 6 for the manufacture of medicinal gases.  

The aim of the revision is to carry out a limited review and update of the guideline to reflect industry’s current practices, including the use of new technologies and computerised systems.

The Concept Paper can be found at www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-6-manufacture-medicinal-gases_en.pdf