NOTICE

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
Health Canada
Holland Cross, Tower B, 2nd Floor, A.L. 3102C2
1600 Scott Street
Ottawa, Ontario
K1A 1B6

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

Date Adopted
1992/06/05

Revision Date
2005/01/31

Health Products and Food Branch

Our mission is to help the people of Canada maintain and improve their health.

Health Canada

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
Tunney's Pasture
Ottawa, Ontario
K1A 0K9

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

Foreward

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
Tel:(613) 941-1049
Fax:(613) 941-1668

RPM servicing Central Nervous System Division (psychiatry, antiemetics and anorexiants)
Tel:(613) 941-0572

RPM servicing Central Nervous System Division (neurology, anaesthesiology, and pain management)
Tel:(613) 952-2006

RPM servicing Allergy and Respiratory Drugs Division
Tel:(613) 941-1382

RPM servicing Cardio-Renal Division Tel:(613) 941-0937

Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)

SRPM servicing BGIVD
Tel:(613) 941-6071
Fax:(613) 941-1183

RPM servicing Division of Anti-Infective Drugs
tel:(613) 946-7004

RPM servicing Gastroenterology Division
Tel:(613) 952-8172

RPM servicing Disinfectants Unit
Tel:(613) 941-0775

Bureau of Metabolism, Oncology and Reproductive Sciences (BMORS)

SRPM servicing BMORS
Tel:(613) 954-6734
Fax:(613) 941-1365

RPM servicing Division of Anti-neoplastic Drugs
Tel:(613) 954-6503

RPM servicing Metabolic and Musculoskeletal Drugs Division
Tel:(613) 941-4814

RPM servicing Reproduction and Urology Division
Tel:(613) 941-0900

Bureau of Pharmaceutical Sciences (BPS)

SRPM servicing BPS
Tel:(613) 941-1666
Fax:(613) 957-3989

RPMs servicing BPS
(613) 948-9237
(613) 948-9238
(613) 941-0680
(613) 948-9236

Senior Medical Advisory Bureau

SRPM servicing Non-Prescription Drug Evaluation Division
Tel:(613) 941-2510
Fax:(613) 954-4474