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Common Technical Document - ICHFootnote 1 Topic M4

2003-06-25

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Notice

Our file number: 03-112019-317

This Notice is to formally advise of Health Canada's endorsement of the ICH guidances on the preparation of Common Technical Document (CTD - ICH topic M4) as published on the ICH website (see below for direct link). This also includes the harmonized companion CTD Questions and Answers documents which have been developed during the CTD implementation process. The M4 guidances are divided into four component documents:

M4 - Organisation:
Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use
M4Q - Quality
Quality Overall Summary of Module 2; Module 3: Quality
M4S - Safety
Nonclinical Overview and Nonclinical Summaries of Module 2; Organisation of Module 4
M4E - Efficacy
Clinical Overview and Clinical Summary of Module 2; Module 5: Clinical Study Reports

The above mentioned guidance documents have been developed by the appropriate ICH Working Groups and have been subject to consultation by the regulatory parties, in accordance with the ICH Process. The ICH Steering Committee has endorsed the final version and recommended its adoption by the regulatory bodies of the European Union, Japan and USA.

In adopting these ICH guidances, Health Canada endorses the principles and practices described therein. These documents should be read in conjunction with this notice and with the relevant sections of other applicable Health Canada guidances.

Guidance documents are meant to provide assistance to industry and health care professionals on how to comply with the policies and governing statutes and regulations. They also serve to provide review and compliance guidance to staff, thereby ensuring that mandates are implemented in a fair, consistent and effective manner.

Guidance documents are administrative instruments not having force of law and, as such, allow for flexibility in approach. Alternate approaches to the principles and practices described in this document may be acceptable provided they are supported by adequate scientific justification. Alternate approaches should be discussed in advance with the relevant program area to avoid the possible finding that applicable statutory or regulatory requirements have not been met.

As a corollary to the above, it is equally important to note that Health Canada reserves the right to request information or material, or define conditions not specifically described in these guidances, in order to allow the Department to adequately assess the safety, efficacy or quality of a therapeutic product. Health Canada is committed to ensuring that such requests are justifiable and that decisions are clearly documented.

In view of the complexity and highly formatted nature of the M4 guidances, Health Canada has decided, on an exceptional basis, to not translate these documents into French. Submission applicants nonetheless have the choice of filing drug submissions in the CTD format in French or English.

Related Health Canada guidance documents are available on the Therapeutic Products Directorate / Biologics and Genetic Therapies Directorate Websites. The availability of printed copies of guidance documents may be confirmed by consulting the Guidelines and Publications Order Forms (available on the TPD Website) or by contacting the Publications CoordinatorFootnote 2.

Should you have any questions regarding the content of the M4 guidances or filing requirements for drug submissions, please contact :

For BGTD submissions:

Submission Management Division
Centre for Policy and Regulatory Affairs
Biologics and Genetic Therapies Directorate
Fax: (613) 957-0364
SMD_Submissions@hc-sc.gc.ca

For TPD Submissions:

Regulatory Project Management Division
Office of Business Transformation
Therapeutic Products Directorate
Fax: (613) 957-1483
RPM_Division-GPR_Division@hc-sc.gc.ca

Comments on the ICH CTD guidances may also be directed to the official ICH website at
http://www.ich.org/ich5c.html

Footnotes

Footnote 1

International Conference on Harmonisation of Technical Requirements for the Registration of Pharmaceuticals for Human Use

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Footnote 2

Tel: (613) 954-6466; E-mail: publications_coordinator@hc-sc.gc.ca

Return to footnote 2 referrer