Navigating regulatory pathways can often feel like a maze, leading to uncertainty and potential pitfalls in the submission process. This is even more so when it comes to combination products. Nothing is more disheartening than investing significant time and resources into developing your combination product, only to face rejection from regulatory authorities due to unclear expectations or insufficient data.
At Qbd Group, we offer comprehensive solutions to navigate the complex process of registering these innovative products in both the European Union (EU) and the United States (US).
Primary Mode of Action (PMOA)
Define whether your product is primarily a medical device or a medicinal product to follow the appropriate regulatory pathway.
Determine the appropriate pathway
If the medicinal product is ancillary, your combination product should be developed in compliance with Regulation (EU) 2017/745 (Medical device regulation). If the medicinal product is principle, it is regulated under the Medicinal Product Directive (Directive 2001/83/EC).
Regulatory pathway for medical device combination products.
The notified body must ask the EMA for a scientific opinion on the quality, safety and suitability of the excipient in three cases:
For other substances, the notified body may seek the opinion of the national competent authority or the EMA, e.g. in cases where the EMA has already assessed a medicine containing the same medicinal substance.
Regulatory pathway for medicinal combination products.
Different types of medicinal products.
Integrated/co-packaged medicinal products:
When a complex product is classified as a medicinal product, specific regulations must be followed depending on its type.
A guide to the regulatory process. The flowchart below outlines the necessary steps to obtain all required documents and quality certificates, based on the guidelines for quality documentation for medicinal products used with a medical device.
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EXCEPTIONAL RA SERVICES THAT MEET YOUR NEEDS
Choosing QbD Group means partnering with a trusted leader in Regulatory Affairs. With over a decade of expertise, we provide tailored support across the entire product lifecycle, ensuring seamless compliance and customer satisfaction on a global scale.
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Have questions about the regulatory pathways for your combination product?
We understand the complexities of navigating EU and US regulations. Whether you’re seeking clarity on the Primary Mode of Action (PMOA), determining the right regulatory pathway, or managing lifecycle requirements, our experts are here to help.
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