EMA Update on GACP Revision

Recommendation

5/6 June 2024

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The European Medicines Agency (EMA) has published on its website the detailed minutes of the Herbal Medicinal Products Committee (HMPC) meeting from 13-15 March 2023. In relation to the previously published Concept paper on GACP revision several issues were addressed at the meeting.

Guideline on Good Agricultural and Collection Practice (GACP) of Starting Materials of Herbal Origin

After a presentation on key points by a Co-Rapporteur, the HMPC discussed some issues known to cause difficulties in procedures and ideally to be addressed during the revision for more clarity in the context of updating the GACP Guideline. The following specific issues to be addressed were discussed:

• The status of powdered herbal substances.
• Requirements on the collection from the wild.
• The specific consideration of indoor cultivation.
• Common drying techniques.
• Fumigation with CO2.
• Relevance of the GACP Guideline for herbal starting materials of ‘non-herbal’ Medicinal Products.
• The later involvement of GMP Inspectors was advocated.
• Reference is made to GMP requirements applicable to the early manufacturing steps for comminuted plants and herbal extracts used as active substances.

More information is available in the HMPC Minutes for the meeting from 13-15 March 2023 published on EMA´s HMPC: Agendas, minutes and meeting reports website.