[ICH4 and pharmacopoeias: similarities and differences].

Since 1990, the pharmacopoeias have been regularly consulting each other on their programmes of work and have set up a Pharmacopoeial Discussion Group. This group meets regularly (twice a year) in Europe, Japan and the United States. About fifty monographs on excipients and general methods of analysis proposed by national associations of manufacturers of pharmaceutical products have been selected for convergence and harmonization among the three pharmacopoeias. The pharmacopoeias also participate in the work on the rapprochement of licensing dossiers within the framework of the cycle of international conferences known as ICH organised by the licensing authorities and manufacturers' associations of Europe, Japan and the United States. The pharmacopoeias have observer status in the QWP and Biotech WP and notably have participated in the elaboration of guidelines on analytical validation, impurities, residual solvents and specifications. If necessary, they integrate the general principles of these guidelines into their specifications.