Drug device combinations (DDCs), antibody drug conjugates (ADCs), and the use of statistics in comparability assessments are among the current focal points of the European Biopharmaceutical Enterprises (EBE) in its efforts to identify and build consensus around the most pressing issues on the global regulatory agenda for biotech manufacturing and control.
A specialized group within the European Federation of Pharmaceutical Industries and Associations (EFPIA), EBE plays an important role in the biopharmaceutical regulatory discussions in Europe and in interfacing with EMA’s Committee for Human Medicinal Products (CHMP) Biologics Working Party (BWP) on industry’s priorities and concerns.
In the wake of EMA’s February 2017 proposal for a DDC quality guideline, EBE released a broad-based “reflection paper” in January 2018 providing “an industry perspective on the EU marketing application technical requirements, regulatory review process and post-approval device-related change assessment” for medicinal products incorporating a drug delivery device component. [See IPQ May 10, 2018 for more on the DDC regulatory developments in Europe.]
EBE is currently finalizing a “position paper” focused more specifically on the impact of Article 117, which is amending the Medicinal Products Directive to require a notified body (NB) opinion on these combination products. The group is also leading a cross-industry letter to European Commission (EC) outlining its concerns about how Article 117 is going to be implemented in practice.
Also under development is a position paper scheduled for release this year on developing an efficient lifecycle control strategy for DDCs to give flesh to the outline in the EBE reflection paper of the challenges involved.