Further proposed Vanessa’s Law amendments coming to the Food and Drug Regulations and Medical Devices Regulations. On April 22, 2017, the Government of Canada 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 most recently 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. Interested parties may make representations concerning the proposed Regulations within 75 days of April 22, 2017.
Proposed amendments to Food and Drug Regulations and the Medical Devices Regulations to publicly release clinical data after completion of regulatory review process
Following release of a white paper in March, on December 9, 2017, Health Canada released proposed amendments to the Food and Drug Regulations under which “clinical summaries, reports and supporting data of clinical trials submitted in support of a drug submission” would cease to be treated as confidential and released to the public following a final regulatory decision. Analogous amendments are proposed to the Medical Devices Regulations for Class III or IV medical device applications. Release would not require notice to the affected party.
Exception would be made for:
- information that the manufacturer did not use in the drug submission or medical device application to support the proposed conditions of use or purpose for the drug or medical device; or
- information that describes tests, methods or assays that are used exclusively by the manufacturer.
For these exceptions only, the manufacturer would have the opportunity to propose redactions before publication, to be considered by Health Canada. The proposed amendments would apply to clinical information in drug submissions and medical device applications filed both before and after they come into force. Comments will be received until February 22, 2018.
Updated 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. 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.