A STUDY OF PROCEDURES FOR DOSSIER PREPARATION AND THEIR MARKETING AUTHORISATION IN DIFFERENT COUNTRIES OF SELECTED DRUG(S)

 

 

Table 3: Summary of Some Key National or Regional Differences in Module 3.2.S

Nation/region

Key differences

European Union

3.2.S Drug substance data may be submitted as an EU 2-part DMF (Open Part to be reproduced in 3.2.S) or as a reference to a Ph. Eur Certificate of Suitability (for Ph
Eur monograph substances)

3.2.S.7 Stability: Storage requirements to be stated in accord with CHMP guideline

United States

3.2.S Reference may be made in the dossier to DMF information supplied directly by the drug substance manufacturer to FDA

3.2.S.7 Stability: Storage requirements to be stated in accord with FDA labeling
requirements

Japan

 3.2.S Reference may be made in the dossier to DMF information supplied directly by
the drug substance manufacturer

Canada

3.2.S Reference may be made in the dossier to DMF information supplied directly by
the drug substance manufacturer

Australia

3.2.S Drug substance data may be submitted as a 2-part DMF (Open Part to be
reproduced in 3.2.S) or as a reference to a Ph. Eur Certificate of Suitability (for Ph
Eur monograph substances)

Table 4: Summary of Some Key National or Regional Differences in Module 3.2.P

Nation/region

Key differences

European Union

3.2.P.1 Description and Composition: Colors to be on the European Union permitted list. Excipients to be designated as conforming to Ph Eur or a European national pharmacopoeia where there is a monograph.

3.2.P.4 Excipients: To conform to Ph Eur/European national pharmacopoeia if described in a monograph.

3.2.P.5 Control of Drug Product: Assay limits to be ± 5% unless justified. A different manufacturing and shelf-life specification may be required.
Products to conform to general monographs of the Ph Eur.

3.2.P.7 Container Closure System: Name of manufacturer(s) not required unless product is critical (e.g., parenteral).

3.2.P.8 Stability: Storage requirement to be in accord with CHMP guideline.

United States

3.2.P Reference may be made in the dossier to DMF information supplied directly to FDA by excipient and container/closure manufacturers.

3.2.P.1 Description and Composition: Colors to be on FDA permitted list. Excipients to be designated as conforming to USP/NF where there is a monograph.

3.2.P.4 Excipients: To conform to USP/NF if described in a monograph.

3.2.P.5 Control of Drug Product: Assay limits allowed to be up to ± 10%. A single regulatory (shelf-life) specification is allowed.

3.2.P.7 Container Closure System: Name of manufacturer(s) required.

3.2.P.8 Stability: Storage requirement to be in accord with FDA requirements for wording.

Japan

3.2.P.1 Description and Composition: Colors to be on Japanese permitted list.

3.2.P.4 Excipients: To conform to monographs of the Japanese Pharmacopoeia or Japanese Pharmaceutical Excipients.

Canada

3.2.P.7 Container/Closure: Reference may be made to a DMF from the supplier.

3.2.P.8 Stability: Storage conditions to refer to Health Canada requirements (e.g., storage at controlled room temperature).

Australia

3.2.P.1 Description and Composition: Colors to be on Australian permitted list for colors in oral products.

3.2.P.8 Stability: Storage conditions to refer to TGA list of acceptable storage conditions (e.g., Store below 30◦C).

Module 4 Differences
There are usually no major differences in this module.

Module 5 Differences
Some of the key differences are summarized in Table 5.

Table 5: Summary of Some Key National or Regional Differences in Module 5: Clinical Studies

Nation/region

Key differences

Europe

Where required BE studies for generic products need to use a European batch of
reference product.

Clinical trials should normally comply with CHMP Efficacy guidances where these exist.

Clinical trials of new drug products versus European authorized “gold standard treatment” are important as well as placebo studies

United States

 Clinical trials should normally comply with FDA regulatory guidances where these
exist.

FDA Integrated Summaries of Safety and Efficacy (ISS/ISE) to be included in 5.3.5.3
Reports of Analyses from More than One Study (these are normally required in
addition to the Clinical Overview and Clinical Summary in 2.5 and 2.7)

Japan

“Bridging” pharmacokinetic and clinical studies may be needed to allow foreign data
to be extrapolated to the Japanese population if the clinical studies performed outside Japan

Other Non-ICH countries

“Bridging pharmacokinetic and clinical studies may be needed to allow foreign data
to be extrapolated to the national population if the clinical studies are performed outside these countries

Managing the Differences
If companies wish to file simultaneously in a number of the major developed world markets, the chemical, pharmaceutical, nonclinical, and clinical development program needs to be designed to meet all of the individual market regulatory needs. For example, additional “bridging” pharmacokinetic or clinical trials may be needed to support a foreign registration file in Japan. Most of the documentation in Modules 2 to 5 for a major new drug registration file can be identical, but where there are national differences in requirements (e.g., differences in 3.2.P.5.1 Drug Product Specification in terms of assay limits for the European Union and U.S. markets), it is usually more efficient to prepare the two versions of the document at the same time. The Module 2.3 Quality Overall Summary and the Module 2.5 Clinical Overview could be prepared as identical “core documents” but they should then be reviewed by in-country staff and customized as necessary to meet any different technical or regulatory requirements of the different agencies.

ADOPTION OF THE CTD FORMAT OUTSIDE THE ICH REGION
The CTD format is being adopted with local modifications as needed by other national regulatory agencies and regional groupings of agencies. The Association of Southeast Asian Nations (ASEAN) comprises Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam. These countries have a combined population of over 550 million. They have published the ASEAN CTD (10). The ICH format is allowed for NCE and Biological products, but compliance is needed with ASEAN technical requirements [e.g., the ASEAN guideline on Stability Study of Drug Product (10)] and the ASEAN CTD (ACTD) administrative requirements. The ACTD will be implemented across the whole region by January 1, 2009.

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