Health Canada Module 1 Updates and Progess Towards ... - TOPRA

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A Multidisciplinary Tabular Summary section (1.4.3) has been added 1 . The title of Module 1.6 has been changed from Electronic Review Documents to Regional Clinical Information and now contains comparative bioavailability information for pivotal comparative bioavailability (bioequivalence) studies (1.6.1). Module 1.7 Clinical Trial Application and Clinical Trial Application Amendment (CTA-A) Specific Requirements has been added. 7 The section includes; submission rationale / brief (1.7.1), study protocol (1.7.2), informed consent forms (1.7.3), Canadian research ethics board (REB) refusals (1.7.4) and information on prior-related applications (1.7.5). A section for appendices has been added (1.A). The electronic review package (1.A.1) is the only item listed in this section. All electronic media submitted to support the drug submission or application should be placed in this section. Health Canada also made major changes in its Module 1 metadata, including adding elements applicant, product-name, dossier-identifier, dossier-type, regulatory-activity-type, regulatory-activity-lead and removing elements submission-identifier, and submission-date. The eCTD Regulatory Transaction Information section allows information about the submission and sequence to be included in a form which is easily processed. 7 This information, broadly categorized as metadata, allows Health Canada to more effectively manage incoming electronic submissions and lowers the possibility of errors introduced by manually re-entering this key data. On the technical front, the revised eCTD guidance calls for a technical change to the use of a Schema instead of DTD. 9 The current implementation timeline to accept regulatory activities built with the revised Canadian Module 1 Schema is late September 2012 9 . As of March 21, 2013, Health Canada will no longer be accepting regulatory activities built with the old Canadian Module 1 DTD 9 . Periodic Safety Update Reports (PSURs) requested during the pre-market review process by Therapeutic Products Directorate (TPD) and Biologics and Genetic Therapies Directorate (BGTD) may be filed in eCTD format. 15 PSURs submitted to the Marketed Health Products Directorate (MHPD) may not be filed in eCTD format. SNDS and SANDS are not longer limited to being filed when the original NDS or ANDS was in eCTD format. 15 Health Canada will now allow a sponsor to switch to eCTD format for any major submission (like the FDA and EMEA). 10 Next Steps At this time, the plan and timeline for implementation includes; publication of the final version of this guidance and the final Canadian Module 1 Schema by end of March 2012, regulatory activities built with the revised Canadian Module 1 Schema to be accepted by end of September 2012, transition of eCTD Page 6 of 11
submissions to the proposed Module 1 format by March 21, 2013 at which time Health Canada will no longer be accepting regulatory activities built with the Canadian Module 1 format. 4 HC-FDA Regulatory Cooperation Council (RCC) Initiatives The Health Canada -FDA Regulatory Cooperation Council (RCC) released the Joint Action Plan on Regulatory Cooperation on December 7, 2011. 16 The Joint Action Plan is a practical first step to increased regulatory cooperation between the United States and Canada. Implementation of a common electronic submission gateway, common monographs for over-the-counter drug (OTC) and good manufacturing processes are the first three RCC initiatives. Action plans for each initiative were released in May 2012 and are expected to be completed within two years. 16 Implementation of a Common Electronic Submission Gateway, using the current US gateway that allows industry clients the ability to submit large size electronic documents seamlessly to Health Canada and US FDA with a view toward further catalyzing increased review collaboration between the two regulatory agencies, increased efficiency of sovereign decision making, and improved access to the introduction of medicines for patients in both countries. Current plans include a pilot of this the e-submission gateway process this summer with the intent of going live by the end of 2012. 16 The objectives of the RCC monograph alignment working group are to conduct a pilot program to develop aligned monograph elements for a selected over-the-counter (OTC) drug category (e.g. aligned directions, warnings, indications and conditions of use). Subsequently, the plan is to develop recommendations to determine the feasibility of an ongoing mechanism for alignment in review and adoption of these OTC drug monograph elements. 16 Finally, there is a plan to enhance collaboration on enforcement and compliance by increasing mutual reliance on each other’s routine surveillance good manufacturing practices (GMP) inspection reports of manufacturing facilities for drugs and personal products, rather than having to conduct unnecessarily duplicative inspections in the other country. 16 Conclusion Health Canada has made a great deal of progress towards the goal of moving to an eCTD only submission process however there is still work to do. At this time, Health Canada is still accepting regulatory submissions using the hybrid format. 17 Through the formation of the RCC, Health Canada and the FDA will be able to align to common international data standard requirements (e.g. Regulated Product Submissions) to support two-way communications and submission lifecycle management. The FDA is Page 7 of 11
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