Herbal Drugs: Concept Paper on GACP Revision Published

EMA´s HMPC published the previously announced concept paper on the revision of the guideline on good agricultural and collection practice (GACP) for starting materials of herbal origin. The deadline for comments is 1 June 2022.

Background

To obtain consistent and reproducible herbal starting materials, an adequate quality assurance system for the collection and / or cultivation, harvest, and primary processing (e.g. initial process steps that take place in the field) is required. With the growing number of companies involved ( e.g. Cannabis cultivators), several improvements can be envisaged. Since the publication of the revised EU GMP Annex 7 (Manufacture of Herbal Medicinal Products) in September 2009, some questions about the applicability of GACP and / or GMP have emerged. Therefore, an update to the current GACP guideline is required. In addition, the EMA previously clarified the GMP requirements for herbal substances (i.e., comminuted plants and herbal extracts) used as APIs.

GMP vs GACP

The revision of the guideline will address the need for clarification relating GMP vs GACP, diverse practice in Member States, uncertainty about requirements, certification and dossier submission, comparison to other GACP standards (e.g. established by the World Health Organization, WHO). Improving the existing guideline will also enhance consistency with other EU Directives and Regulations (e.g. on water, soil, pesticides).

According to the HMPC, the revised guideline is expected to facilitate a better understanding of applicable requirements for assuring and demonstrating that herbal starting materials were collected and / or cultivated in a GACP compliant manner. Furthermore, benefits are expected for applicants in the preparation of their dossiers (e.g. providing a written GACP declaration for the herbal substance) and for competent authorities in their assessment of these dossiers.

Timelines

The HMPC anticipates that the GACP draft guideline could be available six months after adoption of the concept paper. The draft will then be released for external consultation for three months. The revised guideline could be finalized within six months after public consultation.

Other topics

The HMPC has recently published a guidance on Nitrosamines in herbal medicinal products (HMPs) and is working on Elemental Impurities in HMPs (see Herbal Drugs: Ph. Eur. Cannabis Monographs and other relevant Topics).

More information is available in EMA´s Concept paper on the revision of the Guideline on Good agricultural and collection practice for starting materials of herbal origin.