In June 2021, the European Pharmacopeia Commission (EDC) chose to embark upon the drafting of a new general chapter on phage therapy active substances and medicinal products for both human and veterinary use. The Bacteriophages Working Party was tasked with the research and drafting of this text, which can now be consulted on the EDQM website.

The draft general chapter (35.2) is now open for public consultation, until the end of June 2023.

Open consultation on European Phage Monograph

This represents a unique chance to help shape the future standards for this innovative modality – anyone in the phage therapy field can seize this opportunity and share their expertise about the state of the art of phage science for human and veterinary medicine.

For more information about how to comment on the draft general chapter, you can download the EDQM guide here.

Read the EDQM public consultation on the Phage Therapy monograph press release here.

Experts in the field are well aware of the potential that bacteriophages and their application to treating disease (phage therapy) represent in the context of increasing antimicrobial resistance. Phage therapy active substances and medicinal products are a particular type of biological medicinal product, in the sense that they are based on viruses (bacteriophages) which are highly specific to their target bacterial organism.

Regulatory science tools are key to overcoming development challenges

There remain several challenges in the realization of this potential, however; traditional pharmaceutical modalities and existing regulatory frameworks are ill-equipped to foster a fertile ground for phage innovators, and as such phage therapy researchers and developers have a large task ahead of them when it comes to adapting GMP-level requirements to the specific nature of phage therapy active substances and medicinal products. Nonetheless, phage therapy development can benefit greatly from other relevant regulatory science approaches, notably those used for Advanced Therapy Medicinal Products (ATMPs).

About the European Directorate for the Quality of Medicines (EDQM)

The EDQM is a leading organisation that protects public health by:

  • enabling the development,
  • supporting the implementation and
  • monitoring the application

of quality standards for safe medicines and their safe use which are recognised as a scientific benchmark and applied worldwide.

Learn more about the EDQM here (EDQM ‘At-a-glance’).