New Drug Submissions - Overview
New Drug Submission (NDS) is a process through which new drugs are approved and controlled by the Canadian Health Authority before entering the Canadian market. In Canada, new drugs are regulated under Part C, Division 8 of Food and Drugs Regulations. The applicant will receive authorization to sell new drugs in Canada via the NDS submission under Section C.08.002 of the Food and Drugs Regulations.
An NDS application, along with all the information required per the Canadian Food and Drugs Act and Regulations, must be submitted to Health Canada for necessary review and approval. Upon satisfactory NDS submission and confirmation on the quality, safety, and efficacy aspects of the new drug, the Agency will issue a Notice of Compliance (NOC), which will enable the sponsor to move toward the next steps for market entry.
Supplement to a New Drug Submission (SNDS) is a supplement application submitted to Health Canada to notify changes that have substantial potential for an adverse effect on the identity, strength, quality, purity, or potency of a drug product.
Freyr assists sponsors with end-to-end Regulatory support for the Health Canada NDS submission process, starting from pre-NDS meetings to submission of the Market Notification and Lifecycle Management (LCM) activities like change submissions like Notifiable Changes (NC)/supplements (SNDS), etc.
New Drug Submissions - Expertise
- Strategic expertise in performing suitability assessment and necessary guidance on requests for Priority Review status of NDS, Notice of Compliance with Conditions (NOC/c), or Extraordinary Use New Drug Submission (EUNDS).
- Gap analysis of source data against the New Drug Submission (NDS) requirements for various types of medicinal products (small molecules, biologics, radiopharmaceutical components, etc.) and mitigation strategy for identified Regulatory gaps.
- The compilation, technical review, and submission of the NDS package as per the current Food and Drugs Regulations and submission of the NDS in the eCTD format.
- Regulatory support for pre- and post-license submission interactions and follow-up activities with Health Canada throughout the NDS approval program.
- Scientific/expert advice on risk mitigation plans for product development issues and Health Canada NDS submission strategy.
- Regulatory support to assess, classify, and submit the post-Notice of Compliance (NOC) changes as per Health Canada guidance.
- Regulatory response strategy during the application screening or scientific review process. Response support includes preparation and on-time response to clarification requests, Screening Deficiency Notices (SDN), Notice of Non-compliance (NON), Notice of Deficiency (NOD), requests for reconsideration letters, etc.
- Regulatory support for pre-submission or pre-application meetings by interacting with the appropriate directorate of Health Canada, and preparation of meeting requests, meeting packages, and other post-meeting requirements.
