Q4B_Frequently_Asked_Questions_26.AprilQ4B：常见问题与解答-质量人文档

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ICH Q4B Frequently Asked Questions Document Document Date :

26 April 2012

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1. What is PDG?

The Pharmacopoeial Discussion Group (PDG) was formed in 1989 with representatives from the European Directorate for the Quality of

Medicines (EDQM)/European Pharmacopoeia (Ph. Eur.), United States Pharmacopoeia (USP), and Japanese Pharmacopoeia (JP) to

work on harmonising excipient monographs and general chapters in the pharmacopoeias. In 2001, the PDG welcomed the World Health

Organization (WHO) as an observer. While not part of ICH, the PDG typically met in conjunction with the ICH and provides the ICH

Steering Committee with reports of its harmonisation progress.

The PDG considers proposals made by national and regional associations of manufacturers of pharmaceutical products and excipients in

order to select general methods of analysis and excipient monographs for addition to its harmonisation work programme. To promote

these exchanges and synergy, since 2001, the PDG has organised, upon request, hearings for representatives of the pharmaceutical and

excipient industries. At all times, PDG works to maintain an optimal level of science consistent with protection of the public health.

Each pharmacopoeia is responsible for a programme of international harmonisation. Each text drafted by the three co-ordinating

pharmacopoeias is published for public comment at PDG Stage 4 in each of their respective forums. Please refer to the Working

Procedures of the PDG, for further information. See the pertinent pharmacopoeial website.

2. What is Q4B?

Q4B is an ICH Expert Working Group (EWG) established in November 2003. As with all of the ICH EWGs, it is composed of regulators

and industry representatives of the three ICH regions, with some observers. The subject of Q4B is "Evaluation and Recommendation of

Pharmacopoeial Texts for Use in the ICH Regions". The texts evaluated by Q4B are primarily the result of harmonisation by the

Pharmacopoeial Discussion Group (PDG). The aim of Q4B is to recommend that the texts published in the three pharmacopoeias (Ph.

Eur., JP and USP) can be used as interchangeable. Texts determined to be interchangeable, can be used by industry and accepted by the

regulators of the three regions. The recommendation of interchangeability is provided in a series of topic-specific “Annexes” as published

on the ICH website (www.ich.org).

The initial scope, as approved by the ICH Steering Committee, was composed of the 10 general chapters mentioned in the ICH Guideline

Q6A on specifications, subsequently expanded with 5 additional chapters. The scope does not include any excipient, drug substance, or

drug product monographs.

The overall process of Pharmacopoeial Harmonisation (Q4A: PDG) associated with the process for evaluation of interchangeability (Q4B

EWG) defines the current framework of ICH Q4.

ICH Q4B Frequently Asked Questions Document Document Date :

26 April 2012

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3. Why is Q4B necessary?

One of the ultimate goals for the pharmaceutical industry is the ability to generate analytical data by a single test method which is

acceptable in each region. This goal of interchangeable test methods has not been achieved, and companies have been forced to perform

multiple tests due to lack of harmonisation among the pharmacopoeias. One of the approaches taken to address this issue is the effort

by the Pharmacopoeial Discussion Group (PDG) for the harmonisation of JP, Ph. Eur., and USP. The PDG-harmonised text would be

interchangeable if implemented without change in each pharmacopoeia. In reality, some modifications are usually made to the

harmonised text as it is incorporated into each pharmacopoeia, due to regional requirements. Therefore, it is crucial for pharmaceutical

companies to assess the acceptability of data obtained per a particular pharmacopoeia in the other regions, or determine the necessity of

repeating the test per the regional pharmacopoeia requirement.

If the Q4B process were not in place, pharmaceutical companies would have to investigate the similarity or differences among the

pharmacopoeias and judge the interchangeability of the data by themselves. The acceptability to the regulatory agencies of such

judgment by the companies is not clear until the submission is made, and hence the companies take on a larger workload and potential

regulatory risks.

Q4B compares the PDG-harmonised text with each pharmacopoeial text as officially published and evaluates the interchangeability

based on a review of any differences from the PDG-harmonised text. As an outcome of Q4B evaluation, each topic-specific Annex

indicates whether and how the regulatory authorities will accept the chapters as interchangeable when the Annex is implemented in

each region. The Annex also states the conditions for interchangeability, which helps the pharmaceutical companies to understand the

points to be noted during drug development, at the time of submission, and for compliance during product lifecycle.

In addition, Q4B comments facilitate PDG in revisiting local requirements or non-harmonised attributes, with the possibility of

eliminating these residual differences.

4. How does industry use the Q4B Annexes?

Implementation of the Q4B Annexes is intended to avoid redundant testing by industry. A pharmaceutical manufacturer who follows

the conditions (if any) detailed in Section 2 of a particular Q4B Annex is assured that the pharmacopoeial chapters listed in the Annex

may be used as interchangeable to ensure compliance with pharmacopoeial and regulatory requirements in the countries/regions listed

in Section 4 of the Annex. A status of "interchangeable" in the Q4B Annex means that any of the official texts from JP, Ph. Eur., or USP

can be substituted one for the other (appropriately referenced) in the ICH regions for purposes of the pharmaceutical

registration/approval process. Using any of the interchangeable methods, an analyst will reach the same accept or reject decisions

irrespective of which Pharmacopoeial Discussion Group (PDG) pharmacopoeia is used.

The Q4B Annexes give guidance to industry for registration and implementation of the harmonised pharmacopoeial chapters. Section 2

of the Annexes contains the Q4B recommendation of interchangeability, and may include specific considerations regarding the

Q4B_Frequently_Asked_Questions_26.AprilQ4B：常见问题与解答

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