Contact: RPM Division-GPR Division
February 17, 2005
Our file number: 05-104120-52
The revised version of this Health Canada guidance document Drug Submission Status Requests: Therapeutic Products Directorate is now available. The guidance document has been updated to provide current contact information for the Therapeutic Products Directorate's Regulatory Project Management Division. The intent of the document remains unchanged.
This and other Guidance documents are available on the Therapeutic Products Directorate Website.
Should you have any questions regarding the content of the guidance, please contact
Regulatory Project Management Division
Office of Business Transformation
Therapeutic Products Directorate
Holland Cross, Tower B, 2nd Floor, A.L. 3102C2
1600 Scott Street
E-mail: RPM Division GPR Division
Fax: (613) 957-1483
Guidance for Industry
Drug Submission Status Requests: Therapeutic Products Directorate
Published by authority of the Minister of Health
Health Products and Food Branch
Our mission is to help the people of Canada maintain and improve their health.
HPFB's Mandate is to take an integrated approach to the management of the risks and benefits to health related to health products and food by:
- Minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products and food; and,
- Promoting conditions that enable Canadians to make healthy choices and providing information so that they can make informed decisions about their health.
Health Products and Food Branch
© Minister of Public Works and Government Services Canada 2005
Available in Canada through
Health Canada - Publications
Brooke Claxton Building, A.L. #0913A
Tel: (613) 954-5995
Fax: (613) 941-5366
Également disponible en français sous le titre : Demandes de statut des présentations de drogue: Direction des produits thérapeutiques
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 this guidance, 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.
This document should be read in conjunction with the accompanying notice and the relevant sections of other applicable guidances.
The following outlines the process drug submission sponsors should follow when making inquiries to the Therapeutic Products Directorate (TPD) about the status or progress of their human drug submissions.
This guidance is part of TPD's ongoing activities to streamline administrative processes and expedite drug submission review. In particular, it will prevent reviewers' time from being eroded by repeated calls from submission sponsors.
Regulatory Project Managers have been assigned to each review bureau, and will serve as the primary points of contact between the review bureau and the submission sponsor. Sponsors with questions about the status or progress of their submission are requested to contact the Regulatory Project Manager (RPM) servicing the relevant review division, or the Senior Regulatory Project Manager (SRPM) servicing the relevant review bureau.
Bureau of Cardiology, Allergy and Neurological Sciences (BCANS)
SRPM servicing BCANS
RPM servicing Central Nervous System Division (psychiatry, antiemetics and anorexiants)
RPM servicing Central Nervous System Division (neurology, anaesthesiology, and pain management)
RPM servicing Allergy and Respiratory Drugs Division
RPM servicing Cardio-Renal Division Tel:(613) 941-0937
Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
SRPM servicing BGIVD
RPM servicing Division of Anti-Infective Drugs
RPM servicing Gastroenterology Division
RPM servicing Disinfectants Unit
Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)
SRPM servicing BMORS
RPM servicing Division of Anti-neoplastic Drugs
RPM servicing Metabolic and Musculoskeletal Drugs Division
RPM servicing Reproduction and Urology Division
Bureau of Pharmaceutical Sciences (BPS)
SRPM servicing BPS
RPMs servicing BPS
Senior Medical Advisory Bureau
SRPM servicing Non-Prescription Drug Evaluation Division
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