Stage 7 Interregional Implementation

When a harmonized text has become official in all the three pharmacopeias, EP and USP publish a statement indicating the harmonization status of the text JP publishes a statement to the same effect at Stage 6B. These statements are intended to promote regulatory acceptance of interchangeability of harmonized monographs and general chapters. 

Currently, 29 excipient monographs have reached Stage 6 in the process and have been signed-off and accepted by the three pharmacopeias (Stage 6). To proceed to the next stage in the process, it was necessary for USP to create a new general chapter. The new chapter (1196), Pharmacopeial Harmonization, explains the role of the PDG, defines the PDG process, elaborates on the definitions of harmonized, 

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