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 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).

Europe

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. 

Determine the appropriate pathway

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.

Example-of-different-types-of-dr

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.

Medical-device-combination-produ

USA

Identify FDA center that will have primary jurisdiction for premarket review and regulation.

Depends on PMOA
If needed assist with an RFD

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

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.

Why choose us for combination product lifecycle management?

QbD Group is your trusted partner in navigating the complex regulatory landscape of combination products. Our expertise ensures a streamlined pathway to market while maintaining compliance with all regulatory requirements.

Here's how we stand out:

Tailored regulatory strategy

We help you develop a custom regulatory roadmap to ensure your product meets all compliance and market entry requirements.

Expert guidance on procedures

Our team guides you in selecting the most suitable regulatory procedure for your product, saving time and minimizing hurdles.

End-to-end lifecycle management

From concept to market launch, we offer holistic support for every stage of your combination product’s journey.

In-depth regulatory knowledge

Leverage our extensive expertise to navigate stringent requirements confidently and accelerate your product’s market readiness.

Why partner with QbD Group?

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.

10+ years of experience: benefit from our team of highly qualified consultants.
Full life cycle support: full support from pre- to the post-marketing phase.
Global presence: QbD Group operates globally, at QbD Austria with a special focus on Europe (EU) and China.
Customer satisfaction: constant evaluation, transparency and clear objectives.

Get in touch

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.

Combination Products

Europe

USA

USA