Combination Products
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, 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).
Europe
1. Primary Mode of Action (PMOA) Determination:
Define whether your product is primarily a medical device or a medicinal product to follow the appropriate regulatory pathway.
2. 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:
- if the excipient is derived from human blood or plasma;
- if it has been previously assessed by the EMA;
- if it falls within the mandatory scope of the centralized procedure.
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.
USA
1. Identify FDA center that will have primary jurisdiction for premarket review and regulation
- Depends on PMOA
- If needed assist with an RFD
2. Identify the type of investigational application (IND or IDE)
You should consider the regulatory requirements for when an investigational new drug application (IND) or an investigational device exemption application (IDE) is required in determining whether an investigational application is needed for a combination product, and take into account each constituent part as well as the combination product in making these determinations. Typically, an IND is submitted if the combination product has a drug or biologic PMOA and an IDE if the combination product has a device PMOA
3. Identify Marketing application
Combination products are typically marketed under a marketing authorization type associated with the constituent part that provides the primary mode of action (PMOA) for the combination product (i.e., a new drug application (NDA) or abbreviated new drug application (ANDA) if it has a drug PMOA, a biologic license application (BLA) if it has a biologic PMOA, or a premarket approval application (PMA) de novo certification, or premarket notification (“510(k)”) if it has a device PMOA). A single marketing application is generally sufficient for a combination product. In some cases, however, a sponsor may wish to submit separate marketing applications for different constituent parts of a combination product, and FDA may consider this permissible.
How we support you
- Choose the right procedure for your product
- Advise on a regulatory strategy
- Combination Product Lifecycle Management
- QBD has extensive regulatory knowledge, which ensures efficient pathways to market while meeting stringent regulatory requirements
- Our comprehensive support covers the development of combination products from concept to market launch.
Why QbD Group?
Benefit from our team of highly qualified consultants.
Full support from pre- to the post-marketing phase.
QbD Group operates on a global scale, with offices strategically located across Europe and South America. This extensive network allows us to efficiently execute projects in diverse locations worldwide.
Constant evaluation, transparency and clear objectives.
Contact us
Contact us for more information or to request a free, no-obligation proposal.
