Currently the US Food and Drug Administration’s (FDA) guidance covers cGMP requirements for the constituent parts of combination products, such as drugs, biologics and devices, but the agency believes clarification is needed.
The FDA proposed draft guidance on combination products in 2004 and received 15 comments which it reviewed before deciding there is a need to develop a clear regulatory framework. Respondents added that this should avoid unnecessary redundancy in cGMP operating systems.
Having formulated its proposed rule the FDA believes it has achieved this and estimates that it will have limited negative impact on the 300 manufacturers of combination products, although some may incur one-time incremental costs and 25 hours per product will needed for compliance.
In part this has been achieved by implementing a streamlined approach that would, under certain conditions, allow a manufacturer to demonstrate compliance of a combination product with either the drug cGMP or device quality system (QS) regulation.
By taking this approach the FDA believes the proposed rule minimises the burden on manufacturers, increases clarity and helps ensure there is no duplication in requirements for combination products.
Furthermore, the agency notes the importance of “timely, comprehensive guidance and training”. Consequently it is seeking comments on particular areas of the rule that would be most helpful in designing and implementing a cGMP operating system that complies with the guidance.
The entry in the Federal Register can be viewed here .