EMA: Concept Paper on Agriculture of Herbal Drugs, GMP versus GACP

The HPMC (Committee on Herbal Medicinal Products, HPMC) of the EMA has published a concept paper on Good agricultural and collection practice for starting materials of herbal origin on 1 March 2022. Of interest to GMP professionales is, that the revision of the original guideline dating back to 2006, will address open questions about the applicability of GACP versus GMP, or a requirement of a combination of both. With a growing market for herbal medicinal product, e.g., Cannabis products, enhanced guidelines on the subject intent to clarify open issues.

The revision of the guideline should address and enhance

• the need for clarification and consistency regarding demarcation/overlap GMP versus GACP
• the unification of diverse practice in Member States
• the current uncertainty about requirements
• the certification and dossier submission in accordance with the existing requirements
• the comparison to other GACP standards such as those established by the WHO
• the coherence with other EU Directives and Regulations (e.g., water, soil, pesticides)
• the understanding and compliance by interested parties.

The Concept Paper is open for public consultation until 1 June 2022. For more details on how to submit comments, please refer to the document itself. It is anticipated that a draft of the revised guideline could be available six months after adoption of the concept paper. The draft will be released for external consultation for three months. The revised guideline could be finalised within six months after external consultation.

Source:

EMA: Concept paper on the Good agricultural and collection practice for starting materials of herbal origin