CRED 8 Presentations

03/07/2024

Combination Products

• The EMA has recently adopted a guideline on the quality information that manufacturers of combination products should submit in MAAs. The guideline took effect on 1 January 2022 • Guideline focusses on product-specific quality aspects of a medical device that may have an impact on the quality, safety and efficacy of a medicinal product, and outlines where this information should be placed in the CTD (eg Module 2.3 on manufacturing process developments and Module P.2.F on microbiological attributes). • The guideline should be read in conjunction with the Q&A on the implementation of the MDR.

• Guidance addresses “inconsistent” submissions for drug-device combination products

• Three types of combination products covered

Drug-device combination products:

1.

Medical devices co-packaged with medicinal products

2.

3. Medical devices that are obtained separately by the user for use with medicinal products.

• Examples include single-use pre-filled syringes; single-use pre-filled pens and single-use pre-filled injectors (including autoinjectors); pre assembled, non-reusable applicators for vaginal tablets; dry powder inhalers and pressurized metered dose inhalers that are preassembled with the medicinal product • Examples of medical devices co-packaged with medicinal products include oral administration devices such as spoons and syringes; injection needles; and refillable/reusable pens and injectors, including autoinjectors.

•

The Organisation for Professionals in Regulatory Affairs

37

Combination Products What is it?

Combination

EUROPE

1. A product comprised of two or more regulated components that are physically, chemically or otherwise combined/mixed and produced as one single entity.

Medicinal product (MP) (incl Co-ATMP) or Medical device (MD)

depending on the primary mode of action

Ex. Of MP: Insulin in prefilled syringe Ex. Of MD: steroid eluting stent

Product A/B

2.

Two or more separate products packaged together in a single package or as a unit.

Two or more separate statuses (One MD packed with one MP)

Ex: Graduated syringe with syrup

Product B

Product A

3.

A product packaged separately but intended for use only with a specific approved product, • both products required to achieve the intended use, indication, or effect. • requires change to approved product label

Two separate statuses

Ex.: Biological to be delivered with IV kit, sold separately Drug + CDx

ENOVAP case: - e-cigarette is a medical device - Nicotine either in vial or in cartridge is a medicinal product

Product B

Product A

The Organisation for Professionals in Regulatory Affairs

38

19