This course on Regulatory Affairs (RA) for Natural Health Products (NHPs) will cover the essential aspects of the regulatory process for NHPs, including timelines and Quality Assurance (QA) requirements.
The course will start by introducing the regulatory landscape for NHPs in various regions, such as Canada and the US, and will cover the differences between the regulatory frameworks, and the agencies responsible for regulating NHPs in each region.
Next, the course will focus on the various stages of the regulatory process, starting from product development and pre-market assessment, to post-market monitoring and compliance. It will cover the requirements for clinical trials, safety and efficacy testing, and data submission.
The timelines for each stage of the regulatory process will also be discussed, as are the factors that can impact the timeline. The course will also highlight the importance of proper documentation and record-keeping to meet regulatory requirements.
In addition, the course will cover the QA requirements for NHPs, including Good Manufacturing Practices (GMPs), product labeling, and advertising guidelines. It will also discuss the importance of conducting audits and quality checks to ensure compliance with regulations and to maintain product safety and efficacy.
Learning Points:
Throughout the course, case studies and examples will be used to illustrate key concepts and provide practical insights. By the end of the course, participants will have a comprehensive understanding of the regulatory process for NHPs, including the timelines and QA requirements, and will be equipped to navigate the regulatory landscape with confidence.
