Pharmacopoeial Discussion Group (PDG) meeting

Yokohama, Japan, June 5-8, 2006

Press Release

The Pharmacopoeial Discussion Group [European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP), United States Pharmacopeia (USP)] met in association with the Expert Working Groups of the International Conference on Harmonization (ICH).

Hypromellose Phthalate – This harmonized monograph was signed off.

Methyl Paraben, Ethyl Paraben, Propyl Paraben, and Butyl Paraben – It was agreed to initiate the revision of these monographs and EP was nominated as the Coordinating Pharmacopoeia.

Uniformity of delivered dose of inhalations – This general chapter was added as a new topic and EP was nominated as the Coordinating Pharmacopoeia.

Revision of PDG Working Procedures – PDG has elaborated a revision proposal of the PDG Working Procedures revised in July 2003 in order to reflect the interaction with the ICH Q4B EWG. Therefore, PDG has reviewed the interpretation of Stages 6 & 7 and added a Stage 6C (Indication of harmonization). The former Stage 7 (Inter-regional implementation) was redefined to be Inter-regional acceptance. The date of Stage 7 is common to all three pharmacopoeias and will be assigned after receiving formal notification of regulatory acceptance from Q4B. The Procedures will be officially revised at the next PDG meeting. These efforts will be beneficial for users of the pharmacopoeias and facilitate the work of the Q4B EWG.

Interaction with ICH Q4B – In order to achieve common regulatory acceptance of harmonized monographs and general chapters in the ICH regions, five documentation packages for harmonized general chapters have been submitted by the PDG to the Q4B EWG for their evaluation. These packages detail the harmonized methods for dissolution, extractable volume, particulate matter in parenterals, residue on ignition/sulphated ash and the sterility test. The methods for residue on ignition/sulphated ash and extractable volume have been recognized to be interchangeable by the Q4B group; PDG is awaiting feedback on dissolution and particulate matter in parenterals. A number of issues remain to be resolved for the sterility test in order to achieve regulatory acceptance. Additionally, packages for the PDG harmonized texts on disintegration, uniformity of dosage units and microbiological quality are in preparation for submission to Q4B. On June 7, 2006, the PDG held a joint meeting with Q4B EWG.

Industry Associations – A meeting with industry associations from the three ICH regions was held on June 6, 2006, to exchange information on PDG updates, progress with the current work program and future harmonization needs. Industry associations were encouraged to play an active role in the harmonization process as important stakeholders.

Excipients Councils – A meeting was held on June 8, 2006, with Tri-PEC (IPEC Americas, IPEC Europe, Japanese Pharmaceutical Excipients Council) to discuss the work program on harmonization of excipient monographs. Current issues include the policy for functionality-related characteristics, use of additives and processing aids in excipients, co-processed excipients, and impurities in excipients, and the future of harmonization.

The PDG will hold its next meeting on October 23-26, 2006 in Chicago, USA.