Anonymous, there is nothing that prohibits review of 'combination products' within the ACCESS scheme (noting that the term 'combination product' is not specifically defined in most/all of the jurisdictions that are associated with ACCESS, since it is mostly a US-specific term). However, there may be regulations in specific countries that could delay or prolong approval in that market, assuming all other aspects are aligned between the regulatory authorities.
For example, Swissmedic has incorporated the Medical Device Regulation within its national law, including Article 117 regarding medicinal products with a medical device part ('combination products'). Presuming that you have a 'single integral' combination product (pre-filled drug delivery device, e.g. pre-filled syringe or auto-injector), this would require a Notified Body Opinion, and if that is not provided at the time of application, then that could delay or prolong the review (whereas such a review is not required in any other jurisdiction that is part of ACCESS).
Given how new the ACCESS scheme is, I do not believe a combination product has been approved (in fact, very few drugs have been approved thus far), so there isn't great precedent, but, again, it shouldn't be prohibited. There are likely other regulatory strategy considerations involved as well (timing for the NBOp, timeline synchronization with other non-ACCESS jurisdictions like the EU and US, etc.) - feel free to send me a direct message if you're interested in further discussion.
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Jonathan Amaya-Hodges
Sr. Principal Consultant
jamaya-hodges@suttonscreek.comSuttons Creek, Inc.
United States
https://suttonscreek.com/------------------------------
Original Message:
Sent: 12-Jul-2022 05:28
From: Anonymous Member
Subject: ACCESS Pathway for Combination Products
This message was posted by a user wishing to remain anonymous
Hi all,
I am currently working on a Combination Product (PMOA: Drug). Since we want to launch in several countries I came across the ACCESS pathway approach but couldn't find anything helpful on using the ACCESS pathway for a Combination Product.
Does anyone has experiences with the ACCESS pathway and Combination Products?
Thanks