Companies looking to obtain authorization to market a new pharmaceutical must either file a New Drug Submission (NDS) to Health Canada or a New Drug Application (NDA) to the United States Food and Drug Administration (U.S. FDA), depending on their market-of-interest.
The regulatory dossier must include data around the following:
- Pre-clinical (in vitro and in vivo) studies
- Clinical (human) studies
- Details on the manufacturing, packaging, and labelling of the drug substance and drug product
- Therapeutic claims and side-effects
In summary, what this means is that the regulatory dossier must provide enough information to ensure the safety, efficacy, and quality of the drug product, showing that the benefits of the drug outweigh the risks.
Common Technical Document (CTD)
The information to be presented to the Agency is organized into five (5) modules, using the CTD format, as follows:
- Module 1: Regional Administrative Information
- Module 2: Quality Overall Summaries
- Module 3: Quality, including Chemical, Manufacture and Controls (CMC) sections
- Module 4: Non-clinical Study Reports
- Module 5: Clinical Study Reports
Process and Timeline
As seen in this flowchart, the entire regulatory journey from the initial drug application to its approval takes approximately 6 months for drugs that qualify for accelerated approval and up to 2 years for drugs that follow regular processing timelines, avoiding any delays.
Here are some key points of what happens at each stage:
- Pre-Submission Meeting: An option to get questions or concerns addressed by the regulatory Agency prior to filing the submission.
- Submission Filing: The application must contain all the necessary information to satisfy the regulatory requirements of the appropriate division or directorate within the Agency.
- Review of the Submission: The Agency assigns a review team to evaluate the safety, efficacy, and quality of the product. Additionally, the Agency reviews the labeling of the drug product and inspects the facilities where the drug will be manufactured.
- Decision: If the information provided is deemed adequate, a positive decision is made, and the drug is approved to be released to the market.
- Post-Marketing Activities: Post-market management of the product is critical and includes activities like monitoring of adverse events, Phase 4 clinical trials, reporting of post- approval changes (e.g., manufacturing, labeling, stability, etc.), and risk management plans.
SGS Nutrasource offers full-service consulting in this to make sure the new drug submission process is smooth. The team of regulatory experts extensively researches, compiles, and reviews drug submissions for compliance in Canada and/or the U.S. and files the application to the appropriate Agency, helping clients to achieve regulatory confidence and market access.
Speak to a member of our team on how we help you successfully bring your pharmaceutical to market.