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.
Related GMP News
10.07.2025New Ph. Eur. Chapter for Estragole Determination
10.07.2025EMA Reflection Paper on Data Recommendations for Herbal Medicinal Products
09.07.2025USP HMC Publishes Final Cannabis Flower Monograph
01.07.2025GMP non-Compliance Reports for two Cannabis Sites
20.05.2025Update on the USP CBD Monograph
20.05.2025Proposed USP Quality Attributes for Cannabis in Clinical Investigations