New Drug Submission - Overview
Health Canada’s New Drug Submission (NDS) is the 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 by submitting the NDS pursuant to section C.08.002 of the Food and Drugs Regulations.
The NDS application, along with all the information required as per the Canadian Food and Drugs Act and Regulations, must be submitted to Health Canada for necessary review and approval. Based on the product type, the appropriate branch or directorate in the Canadian Health Authority will review the NDS against the current Regulatory requirements. Upon satisfactory confirmation of 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 towards 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 to have 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 NDS process, starting from the pre-NDS meetings to submission of Market Notification and further Life Cycle Management (LCM) activities like change submissions, Notifiable Changes (NC)/supplements (SNDS), etc.
New Drug Submission - Expertise
- Strategic expertise in performing suitability assessment and necessary guidance on requests for priority review status of the New Drug Submission (NDS), or Notice of Compliance with conditions (NOC/c), or Extraordinary Use New Drug Submission (EUNDS).
- Scientific advice/expert advice on risk mitigation plan for product development issues and NDS submission strategy.
- 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.
- Gap-analysis of source data against the NDS submission requirements for various types of medicinal products (small molecules, biologics, radiopharmaceutical components, etc).
- Mitigation strategy for the identified Regulatory gaps.
- Compilation, technical review, and submission of the NDS package as per the current Food and Drugs Regulations and submission of NDS in the eCTD format.
- Regulatory response strategy during the applications screening or scientific review process. Response support includes preparation and on-time response to clarification requests or response to Screening Deficiency Notices (SDN), or Notice of Non-compliance (NON), or Notice of Deficiency (NOD), request for reconsideration letters, etc.
- Regulatory support to assess, classify, and submit the post Notice of Compliance (NOC) changes as per the Health Canada guidance.
- Regulatory support for pre and post license submission interactions and follow-up activities with the Canadian Health Authority (Health Canada) throughout the NDS approval program.
