Blogs

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ revealed some of our customers’ biggest challenges. This is the final of our three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.

Part 1 of this two part blog series, gave a high-level overview of the new ICH guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.  In part 2 of this blog series, some of the key takeaways will be discussed in more detail.  Q12 is intended to help companies demonstrate increased product and process knowledge, and understand which post-approval changes will require a regulatory submission, as well as the level of reporting for each category.

ICH (International Council for Harmonization) recently adopted (1 Nov 2019) the guideline Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. This guideline includes two annexes and aims to “promote innovation and continued improvement in the pharmaceutical sector”.

Combination products open up new vistas when it comes to delivering innovative therapies to patients in need, but teams bringing these products to the market face a number of significant hurdles. Recent surveys conducted by West at workshops held in PA and AZ have revealed some of our customers’ biggest challenges. This is the first of three blogs focused on these challenges — and how West can help Simplify the Journey™ when it comes to developing a combination product.

On March 26, the Delaware Valley Chapter of PDA and West Pharmaceutical Services, Inc. co-sponsored a workshop: Defining a Strategy for Combination Products, at West’s headquarters in Exton, PA. More than 150 people from 45 companies that provide drug products and combination products attended. In prior PDA events, combination product regulatory challenges have been cited often as an area both of interest and confusion. This workshop aimed to address them.

There are many benefits associated with the use of combination products (e.g., SmartDose® and SelfDose® Drug Delivery Platforms). Since combination products are often patient centered, they are designed to be convenient, assist in maintaining a drug therapy from home, and help to enable better compliance. To ensure these benefits, developers must formulate and execute a proper design verification study to minimize impacts by unknown risks.