Health Canada Issues Three Key Notices to Drug Sponsors

Health Canada has recently issued three notices for drug sponsors that relate to the Intellectual Property (“IP”) Hold letters, mandatory filing of some regulatory activities in Electronic Common Technical Document (eCTD) format and updates to the Guidance Document on data protection of “innovative drugs”, respectively. A summary of each of these notices are provided below:

IP Hold Letters:

On April 7, 2017, Health Canada issued a Notice regarding IP Hold Letters to subsequent entry manufacturers under the Patented Medicines (Notice of Compliance) Regulations and the data protection provisions of the Food and Drug Regulations. According to this notice, the Office of Submissions and Intellectual Property (OSIP) will no longer be sending out IP Hold letters for notifiable change submissions as of May 1, 2017. Instead, the status of the notifiable change submission will be updated to “IP Hold” in the Drug Submission Tracking System - Industry Access (DSTS-IA) to notify sponsors when the review of the submission is complete.

Mandatory Filing in eCTD Format:

On April 24, 2017, Health Canada issued a Notice to confirm that starting January 1^st, 2018, sponsors will be required to file the following regulatory activity types, as well as all additional information and subsequent regulatory activities/transactions (as per section 1.3 of the Guidance Document Preparation of Drug Regulatory Activities in eCTD Format) for human drugs, in eCTD format: New Drug Submission (NDS); Supplement to a New Drug Submission (SNDS); Abbreviated New Drug Submission (ANDS); and Supplement to an Abbreviated New Drug Submission (SANDS). However, exemption from the mandatory eCTD format requirement will be considered on a case by case basis. For more details, click here.

Updates to Guidance Document on Data Protection:

On May 17, 2017, Health Canada published an Update to the Guidance Document: Data Protection under C.08.004.1 of the Food and Drug Regulations, which clarifies the administration of the data protection provisions following recent judicial considerations of the data protection provisions with respect to the determination of “innovative drug”. For example, jurisprudence has confirmed that there are two requirements in the analysis of data protection eligibility for “innovative drugs”: 1) whether or not the medicinal ingredient under consideration is a new chemical entity; and 2) whether or not the generation of the data that supports the approval of the medicinal ingredient under consideration required considerable effort.

The Update also reflects current administrative practices regarding the maintenance of the Register of Innovative Drugs and the application of the six-month pediatric extension. It provides direction regarding how to submit information and correspondence relating to data protection in the current electronic environment.

Summary By: Sumaiya Sharmeen