During the project, the European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia (JP) will discuss the challenges in expanding the harmonisation of pharmacopoeial standards to both active substances and medicinal products.
A new bilateral prospective harmonisation project between the European Pharmacopoeia (Ph. Eur.) and the Japanese Pharmacopoeia (JP) will focus on pharmacopoeial standards for active substance and medicinal product monographs.
Through the harmonisation, alignment of the pharmacopoeial standards in different regulatory jurisdictions, is aimed at decreasing the burden on drug manufacturers to do different compendial tests, according to the organisation European Directorate for the Quality of Medicines (EDQM).
This new project will take place outside of the [Pharmacopeial Discussion Group] (PDG) processes, the EDQM confirmed.
It will be conducted under the framework of the memorandum of co-operation (MOC) and confidentiality arrangement between the EDQM and the Ministry of Health, Labour and Welfare (MHLW)/Pharmaceuticals and Medical Devices Agency (PMDA) of Japan, EDQM noted.
Macitentan and macitentan tablets will be first candidates for the co-operation.
To begin with, JP and Ph. Eur. will work to bilaterally harmonise the two monographs. Specifics of the respective regulatory frameworks will be considered.
Reflections from this project between the European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia could lead contribute to expanding the work of convergence of pharmacopoeial standards”
The groups will discuss the current and future possibilities as well as the challenges in expanding the harmonisation of pharmacopoeial standards to both active substances and medicinal products, EDQM shared.
Reflections from this project between the European Pharmacopoeia (Ph. Eur.) and Japanese Pharmacopoeia could contribute to expanding the work of convergence of pharmacopoeial standards.
Harmonisation of pharmacopoeial standards
The announcement follows a previous move by another country in the Asia region working to improve harmonisation. In October 2023, the Indian Pharmacopoeia Commission (IPC) became a member the Pharmacopoeial Discussion Group (PDG).
At the time, Jaap Venema, PhD, Executive Vice President and Chief Science Officer for USP stated that India’s membership in the group is “the latest step in the USP’s and PDG’s commitment to expand access to PDG quality standards by approximately 1.3 billion people”.
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