latest activities of pdg - pmda

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October 3, 2019The PDG 30th Anniversary Symposium

Latest Activities of PDG

Haruhiro Okuda Ph.D.Chair of Expert Committee, Japanese PharmacopoeiaDirector General, National Institute of Health Sciences

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Today’s Topic

PDG Recent Activities

Overview of PDG Tokyo Meeting 2019

Future Perspective of PDG Activities

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Today’s Topic




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Recent PDG Reform: Background

No progress had been made on some PDG harmonization items inthe PDG work program for a couple pf years or more

In the PDG, the coordinating pharmacopoeia prepare and send adraft to other pharmacopoeias and other pharmacopoeias reviewthe draft with their experts at the Expert Committees and providecomments. Then, other pharmacopoeias review the commentswith their experts at the Expert Committees and provide additionalcomments on the comments. This process was repeated withoutdirect discussion among the experts of each pharmacopoeia andslowed the progress of standard setting.

More strategic approach focusing on harmonization process ratherthan just giving a close look on the status was necessary.

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Recent PDG Reform : Expert Teleconference

Specific issues on each harmonization item were discussed at PDG technical teleconferences.

Q-09 Particulate Contamination – December, 2017 and July, 2019 Scope of harmonization and concept of revision

E-62 Sterile Water for Injection – January, 2018 Issues about limit of impurities

E-08 Carmellose Sodium – September, 2018Issues about assay etc.

G-07 Elemental Impurities – September, 2018 Precision, intermediate precision, quantitation limit.

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Recent PDG Reform : Strategic ReviewPDG has been working for harmonization of about 40 items at the same time.

→ identifying the items requiring specific emphasis is necessary.

Prioritization of work program: PDG started with 5 general chapters and 10 excipient monographs using a prioritization scheme for pilot

→ Applying the scheme for the remaining general chapters→ Re-examining a prioritization scheme for excipient monographs

Effective use of bilateral harmonization:→ Switching from trilateral to bilateral harmonization when bilateral is more useful

G-08 Inhalation, G-17 Uniformity of Delivered Dose of Inhalations, E-33 Saccharin, E-34 Saccharin Sodium, etc.

→Switching from bilateral pilot to trilateral harmonization when trilateral is more usefulE-65 Isostearyl Alcohol, E-66 Myristyl Myristate, E-68 Polysorbate 65

Signed-off Under harmonization Under revision

General Chapters 28 3 10

Excipients 46 14 17

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ICH Q4B GuidelineICH Q4B evaluates and recommends pharmacopoeial texts for use in the ICH regions. Once in agreement as interchangeable, the result will be publicized as a guideline.

ICH Q4B GuidelineMain Body: procedure to evaluate pharmacopoeial texts - adopted in 2007Annex 1 to 14: documents containing the outcomes of evaluation and

recommendations for implementation of each general chapter.Q4B Annexes

No. Topic No. Topic

1 Residue on Ignition/ Sulfated Ash 8 Sterility Test

2Test for Extractable Volume of Parental Preparations

9 Tablet Friability

3Test for Particulate Contamination: Sub-visible Particles

10 Polyacrylamide Gel Electrophoresis

4Microbiological Examination of Non-sterile Products

11 Capillary Electrophoresis

5 Disintegration Test 12 Analytical Sieving

6 Uniformity of Dosage Units 13Bulk Density and Tapped Density of Powders

7 Dissolution Test 14 Bacterial Endotoxins Test

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ICH Q4B Guideline: Maintenance of Annexes

ICH Fukuoka Meeting 2010• ICH Q4B did not reach consensus among all participants and concluded to

cease its activities after implementation of remaining annexes (completed in 2013) → No meeting would be held for evaluation.

• When a revision in pharmacopoeia affects interchangeability, a new provisional Q4B working group would be formed to conduct evaluation.

PDG Strasbourg Meeting 2018 • PDG prepared and agreed to a revision proposal of the Q4B annex

maintenance process.• PDG agreed to review the all existing Q4B annexes according to the proposed

procedure.

ICH Charlotte Meeting 2018The proposed maintenance procedure was approved at the ICH Assembly.• PDG will prepare a revised draft of Q4B annex.• The pharmacopoeias other than Ph. Eur., USP and JP will be notified via IMWP.• The ICH secretariat will conduct a regulatory consultation on the revised annex.

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Today’s Topic




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PDG Tokyo Meeting 2019 (1)

Press Release Draft [Tentative Version]On individual work programme, sign-offs at this meeting

included revisions to monographs on E-55 Gelatin, and E-60

Sodium Lauryl Sulfate. PDG monographs now covers allgrades of Gelatin.

It was also reported that the revision to Q-07 Colour was

signed-off by correspondence in June 2019.

Thus 28 of the 31 General Chapters and 46 of the 60

excipient monographs on the current work programme havebeen harmonized among the PDG Pharmacopoeias.

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Press Release Draft [Tentative Version] In-depth discussions on a number of other items on the

current PDG work programme also took place with a view to

resolving outstanding issues and advancing the items

towards sign-off.

In addition, the Coordinating Pharmacopoeia reported back

on the success of technical teleconference on the revision toQ-09 Particulate Contamination in July 2019.


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Press Release Draft [Tentative Version]PDG discussed and agreed upon path forward for the future

maintenance of ICH Q4B annexes. The timeline will be

presented to the ICH Assembly during November 2019 ICH

meeting.

In addition, PDG started to update the ICH Q4B annexes in

accordance with the new maintenance process (Standard

Operating Procedure of the ICH Working Group Annex5)

which was approved by the ICH Assembly in ICH 2018

Charlotte Meeting. PDG has performed initial review of all the

ICH Q4B annexes as well as the related sign-off texts andeach pharmacopoeia’s local texts.

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Press Release Draft [Tentative Version]PDG discussed a mechanism for sharing the outcome of

PDG evaluation of Q4B annexes as well as the drafts and

final texts of pharmacopeial activities with other

pharmacopoeias outside of PDG. PDG will share the scheme

with the other pharmacopoeias at the upcoming InternationalMeeting of World Pharmacopoeias (IMWP)..

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Today’s Topic




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Change in the Environment surrounding PDGDevelopment of science technology and medical practice and change in regulatory requirements

• Streamlining of harmonization process is required in order to timely prepare and revise pharmacopoeial standards corresponding to development of analytical technology and regulatory changes.

→ PDG works to streamline the PDG harmonization process as well as the ICH Q4B maintenance process.

Further globalization of pharmaceutical supply chain and pharmaceutical market

• Pharmaceutical regulations and pharmacopoeial standards are diversifying as manufacturing and distribution of pharmaceuticals are globalized.

• Switch from harmonization of pharmaceutical regulations and pharmacopoeialstandards among Japan, Europe and the U.S. to global-level harmonization is required (Expansion of ICH membership, IMWP (International Meeting of World Pharmacopoeias)).

→ PDG engages in harmonization activities corresponding to such globalization.

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Further efforts to global harmonization

Transparency of PDG harmonization for PDG users:

Indication of harmonized areas in each pharmacopoeia

→ Indication of non-harmonized attributes/provisions and local requirements by specific symbols; black diamonds and white diamonds

Status update of implementation of harmonized attributes/provisions in each pharmacopoeia by publication of sign-off cover page on the website

Review of harmonization policy including definition of harmonization in response to users’ voices

Transparency of PDG activities toward collaboration with sister pharmacopoeias:

Report periodically to IMWP participant pharmacopoeias on the progress of PDG harmonization

Sharing harmonized documents with IMWP participant pharmacopoeias

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Acknowledgment

EDQM

Dr. Susanne Keitel

Ms. Cathie Vielle

Dr. Emmanuelle Charton

Dr. Ulrich Rose

Ms. Isabelle Mercier

Ms. Lynn Kelso

Dr. Dirk Leutner

USP

Dr. Jaap Venema

Dr. Catherine Sheehan

Dr. Kevin Moore

Mr. Richard Lew

Dr. Jenny Liu

WHO

Dr. Sabine Kopp

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Thank you for your attention.

latest activities of pdg - pmda

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