International Harmonisation of pharmacopoeial monographs
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1 International Harmonisation of pharmacopoeial monographs Dr. Michael Wierer Deputy Head, European Pharmacopoeia Department European Directorate for the Quality of Medicines & HealthCare, Council of Europe, Strasbourg
2 Contents Need for pharmacopoeial harmonisation? Who is PDG? PDG working procedure Why evaluation by ICH Q4B? PDG and Q4B achievements and future activities
3 Pharmacopoeial Harmonisation Starting point: Industry is more and more developing products intended for submission worldwide Aim: single set of global specifications (see ICH Q6A Guideline objective) Avoid redundant testing by suppliers and pharmaceutical industry to meet differing standards
4 PDG: Different regulatory environments JP PMDA/ MHLW Governmental Ph.Eur. EDQM,Council of Europe Inter-governmental USP Independent of Government
5 The PDG: its mission Drives International Harmonisation of requirements in parallel and in co- ordination with the ICH activity Has focused on: Excipients General Chapters
6 PDG process Stage 1: identification Stage 2: investigation Stage 3: expert committee review of first draft Stage 4: forum publication Stage 5: consensus Stage 6: regional adoption, implementation and indication of harmonisation Stage 7: inter-regional acceptance (by Q4B)
7 PDG procedure stage 6 Stage 6: Regional adoption and implementation 6A: Adoption and publication 6B: Implementation 6C: Indication of harmonisation - but highlight residual differences - (Ph.Eur. chapter 5.8)
8 Achievements: excipients 40/62 Excipients monographs Harmonisation by attribute: Recognise sticking points (Non-harmonised-attributes) Publish core harmonisation result Co-operation with Tri-PEC
9 Achievements: General Chapters 27/35 General Chapters 10 of 11 Q6A general chapters 6 biotech general chapters 11 powder characterisation general chapters
10 PDG Process Results in Harmonised Text Individual Pharmacopoeial Approval & Official Printing Process USP Version Ph. Eur. Version JP Version Challenges for the regulators: Do differences impact on the ability to achieve same result with same accept/reject capability? Are they interchangeable?
11 Why evaluation by ICH EWG Q4B? Despite PDG efforts general chapters remained effectively unharmonised Implementation of sign-off texts as agreed? Need for formal declaration of regulatory acceptance to be expedited, to facilitate achieving true harmonisation in practice Considered critical to attain full utility of ICH Q6A GL Industry and regulators promoted such greater cooperation to ICH SC 2003
12 Q4B Topic Specific Annex Process PDG Process PDG Document Submission ICH Process Step 1: Q4B EWG assessment and annex development Step 2: ICH Sign off on draft Q4B annex Regional pharmacopoeial implementation Step 3: Regulatory Consultation on annex Step 4: Annex adopted by ICH Steering Committee Inter-regional Acceptance Step 5: Regional regulatory implementation
13 PDG Achievements in Brussels Sign Off Topics GeneralChapters/Excipients - Laser diffraction measurements of particle size (new) - Carmellose (new) - Dissolution Testing: Rev. 2 - Bacterial Endotoxin: Rev. 1 - Additional minor revisions
14 PDG Achievements in Brussels Process improvements since Portland: - Small working group to monitor and communicate PDG topics on a regular basis beneficial for progress - Development of online repository of PDG documents ongoing - Continuous Process Improvement as standing agenda item
15 Current Status of Q4B evaluation Residue on Ignition (Annex 1) step 5 Extractable Volume (Annex 2) Particulate Matter (Annex 3) step 4 Microbial Contamination (Annexes 4A, 4B, 4C) Disintegration (Annex 6) Uniformity of Dosage Units (Annex 5) Dissolution (Annex 7) step 2 Sterility (Annex 8)
16 Current Status of Q6A General Chapters Bacterial Endotoxins signed-off in PDG, to be submitted to Q4B in July 2009 Colour: Request for more information from JP in order to evaluate impact on Japanese industry
17 Indication of Harmonisation Status PDG agreement to review previously published harmonised excipient monographs to indicate harmonisation status highlight residual differences achieve harmonisation at a higher level
18 Interaction PDG/Q4B SC approved future Q4B activities: Tablet friability (PDG Stage 6) Analytical Sieving (PDG Stage 6) Bulk Density and Tapped Density (PDG Stage 6) Capillary electrophoresis (PDG Stage 6) Polyacrylamide gel electrophoresis (PDG Stage 6)
19 Interaction PDG/Q4B Possible future PDG activities under discussion: Chromatography ph Spectrophotometry (including NIR) Water determination
20 Summary PDG harmonisation process improved Regulatory scrutiny of sign-off and published texts (ICH Q4B) has sharpened the process First texts can be used as interchangeable in the ICH regions Scope of Q4B widened Work on dosage-form general chapters and excipients is the priority Currently EP/USP bilateral pilot project on prospective API harmonisation
21 Thank you
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