Concept Paper on the revision of guideline on Good agricultural and collection practice (GACP) for starting materials of herbal origin published
On March 1st, European Medicines Agency Committee on Herbal Medicinal Products (EMA 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 (EMA/HMPC/398706/2021). The deadline for comments is 1 June 2022.
Proper quality management system for the collection, cultivation, harvest, and primary processing is required to obtain consistent and reproducible herbal starting materials. 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 was initiated.
The goal of EMA’s Committee was to draft a concept paper for revision to address stakeholder requests on required clarifications:
- overlap GMP vs. GACP;
- uncertainty about requirements and diverse practice in Member States;
- GACP certification and dossier submission;
- comparison to other GACP standards (e.g. established by the World Health Organization);
- enhanced 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.
It is anticipated 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.
Previously EMA also tried to clarify the GMP requirements for herbal substances used as API’s (GMP requirements applicable to the initial extraction steps in the manufacture of herbal medicinal products, applicability of EU GMP Guide Part II apply) in Q&A document on GMP for herbal extracts used as active pharmaceutical ingredient (API).