The concept paper on phage therapies for human health goal is to establish a scientific guideline for the pharmaceutical development and manufacture of bacteriophage medicinal products intended for the therapeutic treatment or prophylaxis of one or more specific bacterial infections or infectious diseases in humans.
While there is an established EMA guideline for veterinary medicinal products, there is a notable absence of regulatory guidance for medicinal products intended for human use within the EU. The surge in antibiotic-resistant bacteria poses a significant threat, leading to life-threatening infections. Globally, antimicrobial resistance has emerged as a critical issue.
Guideline discussion
The proposed guideline is designed to closely adhere to the structure of Common Technical Document (CTD) Module 3. It will specifically delineate unique requirements for bacteriophages that have undergone genetic engineering to enhance their properties. In the case of bacteriophages categorized as gene therapy medicinal products, strict adherence to the principles outlined in the provided guidance is essential. However, it is recommended to refer to dedicated guidelines tailored for such products.
This guideline excludes magistral formulas, products derived from bacteriophages, and chemically synthesized bacteriophages. Additionally, the scope of the forthcoming guideline does not encompass other applications of bacteriophages, such as utilizing bacteriophage particles as platforms for vaccine display or employing temperate/integrating bacteriophages to modulate bacterial phenotypes.
Proposed timetable
The concept paper will be shared with the public for three months to gather their thoughts. The Biologics Working Party (BWP) will consider all the feedback received during this time while creating a draft guideline. This draft will then be shared for another six months for more public input. If you want to share your thoughts, you can use a survey created by EMA, which is available here. After the guideline is adopted by CHMP, it is expected to become official six months after its publication. To make this guideline, different groups like EMA-BWP Secretariat, CHMP Biologics Working Party, CHMP, GMP/GDP Inspectors Working Group, and EMA QRD Working Group will work together. The BWP will appoint a rapporteur and a drafting group.
It is expected that the final guideline will come into operation six months after publication following adoption by CHMP.
Impact assessment (anticipated)
No anticipated adverse effects on the industry in terms of resources or costs are expected. The forthcoming guideline aims to elucidate regulatory and industrial requirements related to the development and production of bacteriophages for antimicrobial purposes. Its development will adhere to the guidelines set forth by the European Medicines Agency (EMA) on veterinary phage therapy products and the European Directorate for the Quality of Medicines & Healthcare (EDQM) general chapter on phage therapy active substances and finished products.
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