The European Directorate for the Quality of Medicines & HealthCare (EDQM) has updated its guideline on the content of the dossier for chemical purity and microbiological quality and adopted a new chapter on phage therapy medicinal products.
The updated dossier-content guideline is effective 1 May and replaces a 2019 document. Changes are intended to align the document with the current regulatory environment and are essential to prevent a Certification of Suitability (CEP) dossier from being blocked, according to EDQM.
The directorate highlighted key changes to the three modules. In module one, the directorate advises applicants to pay particular attention to using the appropriate EMA SPOR/OMS ORG_ID and LOC_ID for the CEP holder and manufacturing sites. EDQM published a separate notice about updates to a policy document about identifying manufacturing sites by the SPOR OMS coordinates, which have been made mandatory for all CEP applications since June 2023.
For module two, EDQM updated its template for the Quality Overall Summary (QOS). The QOS “serves as a concise overview of Module 3, highlighting the control strategy applied and how regulatory requirements are met to ensure the quality of the substance, and providing assessors with a clear understanding of the substance’s specification and manufacturing process,” the directorate noted.
The QOS is a mandatory component of the CEP application, EDQM added, and “should be treated with utmost importance” The directorate warned that “a poorly crafted or incomplete QOS can hinder the assessment process and lead to delays, potentially jeopardizing the overall timelines to obtain a CEP.”
In module three, EDQM added new requirements for CEP 2.0 and introduced post-approval change management protocols. The directorate also highlighted its addition of detailed expectations for sections related to the manufacturing process, starting materials and intermediates. Companies will need to adapt to the new guideline to avoid setbacks.
“EDQM will implement a stricter validation of applications at receipt and check whether the submission is in line with the requirements described in the revised guideline and the revised QOS template,” EDQM said. “EDQM may, therefore, block applications at receipt from May 2024 in case these are considered deficient to start the assessment process.”
The directorate published the updated guideline days before adopting a new general chapter on phage therapy medicinal products. Interest in phage therapies has risen as the spread of drug-resistant bacteria has created a need for alternatives to existing antibiotics. The European Pharmacopoeia Commission (EPC) responded by making standardized phage therapy requirements a top priority for 2023 to 2025.
EPC adopted the first text last month. The new general chapter “provides a framework of requirements for the production and control of phage therapy products and allows a degree of flexibility commensurate with the complex approaches currently employed in this emerging and rapidly developing field,” EDQM said.
EPC “decided to exceptionally pre-publish the text” on the EDQM website ahead of its publication in July because of the “high interest in the subject matter.” EDQM said the chapter is “the first up-to-date text of its kind to be published in a pharmacopeia.”
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