Communication with Reviewing Authorities Key to Combination Product Success in Europe and Japan

Communication with reviewing authorities is critical in navigating the combination product regulatory shoals in Europe and Japan as it is in the US. However, the communication channels are not always well-marked, and they differ in each of the three ICH regions.

In Europe, communication with independent assessment organizations known as Notified Bodies is required as part of the drug/device combination registration process for some types of products and not for others. Some types of combination products are classified by the regulators as devices and others as drugs, with different associated approval pathways.

The Japanese regulations classify drug and device combination products based on mode of action, and look similar to the US requirements. However, in practice, successful managing of the nuances of Japan’s combination product registration system requires close communication with its regulatory agency, the Pharmaceutical and Medical Device Authority (PMDA).

The similarities and differences in the registration processes for combination products in Europe and Japan were explored at a session of a DIA/AAPS CMC Workshop held in February in Washington, DC.

[More on the workshop discussions is provided for subscribers here. See also the IPQ “In the News” companion stories on combination product regulatory developments in the US and an industry proposal for shifting toward a more risk-based approach. Nonsubscribers may purchase the full stories for $195 each by contacting Jonathan Trethowan ( For subscription/license information, click here.]