New Drug Submission (NDS) for Canada

New Drug Submission (NDS) for Canada

Health Canada’s New Drug Submission (NDS) process ensures the approval and control of new drugs before entering the Canadian market. Templarpharma offers Regulatory support for the NDS process.

What is Health Canada’s New Drug Submission (NDS) Process?

The NDS process regulates new drugs under Part C, Division 8 of Food and Drugs Regulations. The applicant must submit the NDS application along with required information to Health Canada for review and approval. Appropriate Health Authority branch or directorate reviews the NDS based on product type and current regulatory requirements. After confirmation of quality, safety, and efficacy aspects, the Agency will issue a Notice of Compliance (NOC) for market entry.

What is a Supplement to a New Drug Submission (SNDS)?

A Supplement to a New Drug Submission (SNDS) is submitted to Health Canada to report changes that can potentially affect it. The drug identity, quality, strength, purity, or potency.

Templarpharma’s End-to-End Regulatory Support for NDS Process:

Templarpharma provides Regulatory support to sponsors throughout the NDS process, from pre-NDS meetings to Market Notification submission and Life Cycle Management (LCM) activities. Our services include change submissions, Notifiable Changes (NC), and supplement submissions (SNDS).

Pre-NDS Meetings:

Templarpharma assists sponsors in organizing pre-NDS meetings with Health Canada to address questions related to the NDS process, identify regulatory requirements, and clarify the scope of the NDS application.

NDS Application Preparation and Submission:

Templarpharma prepares the NDS application as per Canadian Food and Drugs Act and Regulations requirements and submits it to the appropriate Health Authority directorate or branch. We ensure that all the information include the submission is accurate and complete.

NDS Review and Approval:

Templarpharma works with the Health Authority to facilitate the NDS review process. Including answering any questions and providing additional information as needed. We also work to ensure the timely approval of the NDS by Health Canada.

Notifiable Changes and Supplement Submissions:

Templarpharma assists sponsors in preparing and submitting Notifiable Changes (NC) and Supplement Submissions (SNDS) to Health Canada. We ensure that all changes are accurately reported, and the submission is complete.

Market Notification:

After the NDS is in approval, Templarpharma assists in the submission of Market Notification to Health Canada for market entry. We ensure that all requirements are met and that the submission is accurate and complete.

In conclusion, Health Canada’s NDS process regulates the approval and control of new drugs before entering the Canadian market. Provides end-to-end Regulatory support for the NDS process, including pre-NDS meetings, NDS application preparation and submission, NDS review and approval, Notifiable Changes and Supplement Submissions, and Market Notification submission.

Expertise you should look for

  • Offers a wide range of regulatory services to support the approval of new drugs in Canada.  strategic expertise includes performing suitability assessments and providing necessary guidance on requests for priority review status of the New Drug Submission (NDS), Notice of Compliance with conditions (NOC/c), or Extraordinary Use New Drug Submission (EUNDS).  also provide scientific and expert advice on risk mitigation plans for product development issues and NDS submission strategy.
  • Team also handles compilation, technical review, and submission of the NDS package in compliance with the current Food and Drugs Regulations, as well as submission of NDS in the eCTD format.  also provide regulatory response strategies 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), Notice of Non-compliance (NON), Notice of Deficiency (NOD), request for reconsideration letters, etc.
  • Provides regulatory support to assess, classify, and submit post-Notice of Compliance (NOC) changes as per the Health Canada guidance.  also offer 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.
  • Team has extensive experience in navigating the complex regulatory landscape in Canada. Can provide guidance and support at every stage of the drug development process.  Work closely with  clients to ensure that their products meet all regulatory requirements and are approved in a timely and efficient manner.
  • Understand that the regulatory process can be challenging and time-consuming. And providing clients with the expertise and support they need to navigate it successfully. Regulatory services are meet the specific needs of each client. Delivering high-quality, reliable, and efficient services.