The Japanese Pharmacopoeia (JP) and the European Pharmacopoeia (Ph. Eur.) are pleased to announce the launch of a bilateral prospective harmonisation project targeting pharmacopoeial standards for active substances and medicinal products. Pharmacopeial harmonisation serves to further reduce the burden on manufacturers to perform different compendial tests by aligning the pharmacopoeial standards in different regulatory jurisdictions.
Since the launch of the Pharmacopeial Discussion Group (PDG) in 1989, the JP and Ph. Eur., together with the United States Pharmacopeia and more recently the Indian Pharmacopoeia, have been working on the retrospective harmonisation of general chapters and excipient monographs. This new bilateral prospective harmonisation project will take place outside of the PDG processes and will build upon the experience gathered over the many years of collaboration between JP and Ph. Eur. to apply it to the elaboration of active substance and medicinal product monographs.
For more information, read the press release:
