NHPD Provides Update on Transition of Assessment of NHP Clinical Trial Applications for Primary Indications Inappropriate for Self-Care

February 19, 2013 By

The NHPD has Transitioned the Assessment of NHP Clinical Trial Applications (for primary indications inappropriate for self-care) and Adverse Reaction Reporting to the TPD.

Health Canada informed the industry through two notices, sent August 2012 and October 2012 of the two phases of a pilot program to streamline the review of NHP Clinical Trial Applications. The first phase of this program involved the transitioning of the assessment of Clinical Trial Applications for certain claims – i.e. those that are inappropriate for self-care, to the Therapeutics Products Directorate (TPD) or Biologics and Genetic Therapies Directorate (BGTD), as appropriate for review1. Amendments to NHP Clinical Trial Applications that are not appropriate for self care, will also be transitioned to the TPD. The second phase of this pilot program involved transitioning all adverse reaction reporting from NHP Clinical Trials to the TPD or BGTD, as appropriate. As of November 27, 2012, the NHPD officially started the transition to move NHP adverse reaction report files to the TPD and/or BGTD. It is important to note that all adverse reaction reporting for Clinical Trials of NHPs has been outsourced to the TPD and BGTD, not just for trials for claims that are inappropriate for self-care.

To help ease the transition the NHPD informed affected stakeholders (i.e. those identified as a contact on a NHP Clinical Trial Application) through notices that were sent out on August 1, October 5 and November 27, 2012 to expect a change in the reporting structure of clinical trials2. The NHPD has indicated that although assessment of NHP Clinical Trial Applications and Amendments to applications for products with indications inappropriate for self care is being transitioned to TPD a similar assessment approach will be maintained, and the same NHPD application forms are to be used. The only major change that you should be aware of is that there has been a significant reduction in the time provided by the NHPD to respond to Information Request Notices (IRNs) from 30 days to 2 days.

Currently, the NHPD is working to develop tools to ensure the transition of information is as seamless as possible, while allowing assessment officers at the TPD or BGTD access to the NHP Clinical Trial Application files. dicentra will be sure to inform you as soon as any new information on the NHP Clinical Trial Application transition is provided by Health Canada.

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1. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/activit/bilat/rod-cr_12-03-12-eng.php

2. http://www.hc-sc.gc.ca/dhp-mps/prodnatur/applications/clini/nhp-psn-eng.php