Proposed amendments to Food and Drug Regulations
Further Vanessa's Law amendments for Food and Drug Regulations and Medical Devices Regulations
Updated guidance on data protection
Proposal to release clinical data after regulatory review
Location change for summary basis of decision documents and regulatory decision summaries
Date for mandatory use of eCTD format confirmed
IP hold for notifiable change submissions
Proposed amendments to Food and Drug Regulations
Health Canada has proposed amendments to the Food and Drug Regulations to allow the import and use of drugs that have been authorised for sale in the United States, the European Union or Switzerland, but not yet authorised in Canada. The minister of health would maintain a List of Drugs for an Urgent Public Health Need. Drugs could be added to the list by the minister on notification of an urgent public health need by certain public health officials and withdrawn from the list one year after the most recent notification. As explained in a Health Canada news release, the motivation for the proposed regulations includes the current opioid crisis, as well as pandemic or other public health emergencies.
Further Vanessa's Law amendments for Food and Drug Regulations and Medical Devices Regulations
On April 22 2017 the government published proposed Regulations Amending the Food and Drug Regulations (Vanessa's Law). Some of the proposed regulations support the coming into force of certain provisions of Vanessa's Law, which received royal assent on November 6 2014 (reported here). In particular, the proposed regulations establish the rules needed to structure the exercise of the new powers to require assessments, tests and studies under Sections 21.31 and 21.32 of Vanessa's Law. The proposed regulations also support post-market drug safety by creating new foreign incident reporting rules (further to Section 30(1.2)(d) of the Food and Drugs Act), and repealing Paragraph C.08.005.1(1)(a), thus eliminating the requirement for the filing of clinical case reports in the filed submission or supplement. The proposed amendments can only come into force once Subsection 6(2) of Vanessa's Law comes into force. An order in council would bring into force this subsection and Sections 4, 10 and 11 of Vanessa's Law six months following the publication of the regulations in the Canada Gazette, Part II.
Updated guidance 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. As explained in the notice, this update clarifies the administration of the data protection regime in view of jurisprudence on what constitutes an 'innovative drug', reflects current administrative practices for maintenance of the Register of Innovative Drugs and the application of the six-month pediatric extension and provides direction regarding electronic submissions and correspondence.
Proposal to release clinical data after regulatory review
Health Canada has proposed to proactively make certain clinical information about the safety and efficacy of drugs and medical devices available to the public once the regulatory review process is complete. To that end, Health Canada released the white paper Public Release of Clinical Information in Drug Submissions and Medical Device Applications in March 2017. The white paper:
"sets out the policy objectives, rationale and considerations for future regulations that would specify that certain clinical information contained in drug submissions or medical device applications would not be treated or cease to be confidential business information following a final regulatory decision and that would authorize the public release of that information."
Interested parties have until May 26 2017 to provide feedback on the paper. Health Canada has also released the final guidance document Disclosure of Confidential Business Information under Paragraph 21.1(3)(c) of the Food and Drugs Act. Health Canada also maintains a list of completed requests for disclosure of confidential business information. The list was disclosed in response to two of the 12 completed requests in 2015 and 2016.
Location change for summary basis of decision documents and regulatory decision summaries
On March 29 2017 Health Canada announced that summary basis of decision documents and regulatory decision summaries for pharmaceuticals, biologics and medical devices are now only available on the Canada.ca website and can be located using the Drug and Health Product Register.
Date for mandatory use of eCTD format confirmed
Health Canada has confirmed January 1 2018 as the date for mandatory use of the Electronic Common Technical Document (eCTD) format for the filing of certain types of regulatory activities and transactions. Types of filing that must be submitted in the eCTD format or are recommended to be submitted in the eCTD format are listed here.
IP hold for notifiable change submissions
On April 7 2017 Health Canada announced that as of May 1 2017 its Office of Submissions and Intellectual Property will no longer notify sponsors by way of an IP hold letter that the review of a notifiable change submission is complete and has been placed on 'IP hold'. Instead, the status of the notifiable change submission will be updated to 'IP hold' in the Drug Submission Tracking System – Industry Access to notify sponsors once the review is complete.
For further information on this topic please contact Daphne Lainson at Smart & Biggar/Fetherstonhaugh's by telephone (+1 613 232 2486) or email ([email protected]). The Smart & Biggar/Fetherstonhaugh website can be accessed at www.smart-biggar.ca.