NDS (New Drug Submission) 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 NDS pursuant to section C.08.002 of the Food and Drugs Regulations.
NDS application, along with all the information required as per the Canadian Food and Drugs Act and Regulations, must be submitted to the Health Canada for necessary review and approval. Upon satisfactory confirmation on quality, safety and efficacy aspects of the new drug, the agency will issue a Notice of Compliance (NOC), which will further enable sponsor to move towards next steps for market entry.
Supplement to a New Drug Submission (SNDS) is a supplement application submitted to the 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 NDS process, starting from pre-NDS meetings to submission of Market Notification and further Life Cycle Management (LCM) activities like change submissions - Notifiable Changes (NC)/supplements (SNDS), etc.
- Strategic expertise in performing suitability assessment and necessary guidance on requests for Priority Review status of NDS (New Drug Submission) or Notice of Compliance with conditions (NOC/c) or Extraordinary Use New Drug Submission (EUNDS)
- Gap analysis of source data against the NDS submission requirements for various types of medicinal products (small molecules, biologics, radiopharmaceuticals components, etc) and mitigation strategy for identified Regulatory gaps
- Compilation, technical review and submission of NDS package as per the current Food and Drugs Regulations and submission of NDS in the eCTD format
- Regulatory support for pre-submission or pre-application meetings by interacting with appropriate directorate of Health Canada and preparation of meeting requests, meeting packages and other post meeting requirements
- Scientific advice/expert advice on risk mitigation plan for product development issues and NDS submission strategy
- 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
- 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 response to Notice of Non-compliance (NON) or Notice of Deficiency (NOD), request for reconsideration letters, etc.