New Drug Submission

 

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.
New Drug Submission

Celebrating Customers Success

 

Medicinal Products

Regulatory Affairs

India

Thank you for the timely support over the weekend, which allowed us to resubmit quickly after being notified. This continuously demonstrates Freyr's commitment towards our company’s milestones.

Director - Global Regulatory Affairs – Operations

India-based, Global Top Generic Pharma Company

 

Medicinal Products

Publishing

UK

I am sure you have heard by now that we have received our first-ever approval from the FDA for our Brands division. This is a major milestone for us as well as for my team here in Reg Ops. I would be remiss if I didn’t point out that we would not have been able to do this without the help of your dedicated team. From the original filing, then the following year of responses, all helped get us to final approval.

Thank you Freyr team for a job well done!

Sr. Director, Head of Regulatory Operations

Ireland-based, Global Specialty Pharmaceutical Company

 

Medicinal Products

Regulatory Affairs

USA

Please relate to the team the excellent job they have done on the IND reactivation. Specifically, the high-quality module 3, written by Freyr. It was very comprehensive, very few revisions were required, and we had no questions from Health Canada or FDA. No CMC questions: that was a first for me. So very responsive to my many requests, which I am sure can be frustrating but always helpful while producing excellent work.

Thank you for always being available and responding quickly and comprehensively to all my requests.

What a great team you have, Freyr.

Lynne McGrath

Regulatory Consultant

 

Medicinal Products

Regulatory Affairs

USA

Congratulations!!! ​

Thanks for your great support for a successful ANDA filing, especially to the publishing team. Heartfully appreciate their last hours of hard work.

Assistant Manager​

US-based, Leading, Complex Generic Pharmaceutical Products Company​

 

Medicinal Products

Regulatory Affairs

USA

Thank you all for the great support!​

CEO

US-based, Leading Innovative Pharmaceuticals Company​

 

Medicinal Products

Regulatory Affairs

USA

The ANDA receipt has been received! Thank you very much for your hard work, patience, and support for our work over the last couple of months. We are delighted that we were able to meet the timeline and hit an important corporate goal of our young company. ​

Thank you again, and we look forward to working with your team on the next project!

Senior Director of Business and Product Development​

US-based, Leading Innovator Pharmaceuticals Company​