Introduction: Abbreviated New Drug Submission (ANDS) in Canada
In Canada, the Abbreviated New Drug Submission (ANDS) application process for pharmaceutical products shares technical requirements with the US FDA and EMA. This simplifies the registration process for products already registered with those authorities. However, Health Canada has unique procedural and technical requirements that require the expertise of a regulatory expert.
Consulting a Regulatory Expert for Health Canada’s Unique Requirements
To ensure a quicker registration and approval process, it’s crucial to consult a regulatory expert familiar with Health Canada’s unique procedural and technical requirements. This includes understanding Drug Establishment License (DEL) requirements, which are mandatory for companies that sell, import, or distribute drugs in Canada.
Templarpharma’s Experience in Handling ANDS Submissions
Templarpharma has prior experience and expertise in handling ANDS submissions for all dosage forms of pharmaceutical products in Canada. Their regulatory experts play a key role in streamlining the registration and approval procedures, ensuring compliance with Health Canada’s unique requirements.
Preparation and Submission of ANDS Applications
Templarpharma assists clients with the preparation and submission of ANDS applications, including review and approval of the Quality Overall Summary (QOS) and the Drug Master File (DMF). They also provide support for post-approval activities, such as label updates, change management, and post-market surveillance.
Navigating Regulatory Challenges and Ensuring Compliance
Navigating regulatory challenges is a key aspect of the ANDS application process. Templarpharma’s regulatory experts have a deep understanding of Health Canada’s requirements and can guide clients through the process, ensuring compliance with all regulations and guidelines.
Benefits of Working with Templarpharma for ANDS Submissions
Working with Templarpharma for ANDS submissions offers several benefits, including faster approval times, a streamlined process, and reduced risk of non-compliance. Their regulatory experts provide end-to-end support, from application preparation to post-approval activities.
Simplifying the ANDS Application Process with Templarpharma
In conclusion, the ANDS application process in Canada requires a thorough understanding of Health Canada’s unique procedural and technical requirements. Working with regulatory experts can simplify the process, ensure compliance, and expedite approvals for pharmaceutical products.
- Regulatory submission road map/filing procedure for ANDS and supporting document generation.
- Regulatory consultation during product development & manufacturing phase for selection of RLD/Reference Standard, review of specifications for finished product/in-process controls/API, Product Development Report, process validation protocol/report, stability study, and guidance on batch size requirements.
- Preparation/review of the ANDS Health Canada submission strategy and guidance on risk mitigation plans.
- Handling pre-submission meetings with Health Canada.
- Support for DEL application submission.
- Providing ANDS documents checklist.
- Gap-analysis/Regulatory assessment of generated source data for Regulatory adequacy.
- Guidance on the generation of additional/missing documents.
- Preparing Abbreviated New Drug Submission package in line with the current Health Canada requirements.
- Publishing and submission of the ANDS in the eCTD format.
- Interaction/follow-ups with Health Canada for the ANDS approval.
- Regulatory strategy and response preparation for HC queries for quicker approvals.