HMPC starts Revision of GACP Guideline

As previously announced, EMA´s HMPC is currently working on the revision of the Guideline on Good Agricultural and Collection Practice (GACP).

The goal is to draft a concept paper for revision to address stakeholder requests on required clarifications, e.g.

• overlap GMP vs. GACP,
• uncertainty about requirements,
• GACP certification and dossier,
• comparison to other GACP standards such as WHO.

The committee now adopted a concept paper for the revision of the Guideline on Good Agricultural and Collection Practice (GACP) of starting materials of herbal origin. The concept paper on the revision of guideline EMA/HMPC/246816/2005 will be published at EMA´s Herbal medicinal products: scientific guidelines website. Interested parties are invited to provide comments by 15 March 2022.

Please find more information in the HMPC meeting report of the 102nd HMPC meeting.