Clearer, more review/inspection coherent, more risk-based, and more harmonized regulatory expectations across the expanding universe of drug/device combination products will continue to be a high-priority focus for the pharmaceutical industry during 2017.
The stresses pharma has been feeling from the disconnects in the drug and device regulations, structures and processes are becoming more acute as the complexity, diversity and importance of the device components of medicinal products increase.
These increasing pressures, in turn, are driving industry to work cooperatively to more clearly define where the regulatory stumbling blocks are and to work more intensely with regulators to address them. The Combination Products Coalition (CPC), the European Biopharmaceutical Enterprises (EBE), The Organization for Professionals in Regulatory Affairs (TOPRA), and the International Pharmaceutical Aerosol Consortium on Regulation & Science (IPAC-RS) are among the groups spearheading initiatives in the combination product arena.
A primary objective for industry is that the regulatory processes be flexible enough to adjust the development, filing, post-approval change and GMP expectations to the actual risks that the combination entails.
Industry’s concern is that, in the absence of more clear and scalable processes and guidance, a “one size fits all” default approach results – for example, a measuring cup carries the same requirements as an implantable disk for brain cancer treatment or other cases where a complex interactive delivery system and/or software are involved.
Missing, the industry groups point out, is the needed clarity, consistency, and harmonization around what information regarding the device components needs to be submitted in drug dossiers, in what detail, and where – with consequences in the sponsor/regulator relationship that stretch across the product lifecycle continuum.
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