European Pharmacopoeia (Ph. Eur.) - Pharmacopoeial Harmonisation - PDG Entry Criteria

The PDG harmonises excipient monographs and general chapters. This reduces the burden on manufacturers to perform analytical procedures in different ways, using different acceptance criteria. At all times, the PDG endeavours to maintain an optimal level of science consistent with protection of public health. Each pharmacopoeia of the PDG commits to this purpose and to respecting the PDG statement of harmonisation policy and working procedures as well as the associated deadlines as an essential part of the harmonisation process.