Cobridge as Your DMAH
There are, of course, a multitude of DMAH outfits in Japan that have arisen in the wake of the PAL amendments to exploit the opportunities that the amendments have made available. Cobridge is no new-comer to the field, having been an in-country agent for foreign manufacturing approval holders long before the PAL amendments. Cobridge’s other qualities set it apart from the multitude, as well.
As mentioned above, Cobridge has comprehensive coverage of DMAH licenses for the full spectrum of medical products. But more than that, Cobridge couples DMAH capabilities with expert, professional in-house staff to prepare approval applications for all types of medical products, from medical devices through drug master files (DMFs) and full approval dossiers for new IVDs. Moreover, Cobridge prepares reimbursement applications for submission to the division of the Ministry of Health, Labour and Welfare (MHLW) that handles approval of medical product reimbursement applications under Japan’s national health insurance (NHI).
Cobridge has the highest-level DMAH licenses (satisfying the highest qualification and requirement for professional staffing) for both pharmaceuticals and medical devices, allowing for the greatest scope of DMAH services. This comprehensiveness in the DMAH licensing is a showcase of the rigor of the company, an illustration of how well qualified it and its full-time staff are—all capabilities, all of the required staffing, for instance, is in-house.
For medical devices, Cobridge has a comprehensive Type 1 DMAH license, allowing it to act as DMAH for all medical devices, Class II through Class IV. (Class I medical devices as elsewhere do not require review and approval by the health authorities and therefore do not invoke the need for a DMAH.)
In vitro diagnostic products (IVDs) previously were handled as pharmaceuticals in Japan. Since implementation of the PMD Act in November of 2014, IVDs have been handled in a manner similar to that of medical devices, and Cobridge has obtained a DMAH license for IVDs.
Finally, Cobridge also has a DMAH license for those OTC products that are regulated in Japan as so-called quasi-drugs. With this DMAH license, Cobridge has filled the final gap, and can handle quasi-drugs and devices.
The use of a DMAH frees the foreign manufacturer from having to accept bundling of regulatory services in distribution agreements, and the attendant inability to track costs that are buried in the transfer pricing. This allows the foreign manufacturer to seek business opportunities with Japanese distributors unencumbered by regulatory concerns. Many Japanese distributors focus on domestic distribution without having given consideration for the requirements to distribute products from international sources. Should a client identify a Japanese distributor that is otherwise favorable, but not in a position of importing, warehousing and releasing product in Japan, then Cobridge can also arrange for an importation, storage, re-packaging and relabeling manufacturer, and for release to domestic distributors of the aforementioned products, from pharmaceuticals, through the entire range of medical devices.
Cobridge as Your Most Cost-effective Option
To appreciate the comprehensiveness and advantage of Cobridge compared to the multitude of DMAH-specializing firms, a time course of the involvement of the DMAH in the regulatory pathway to market is illustrative. The approval application must be submitted by a DMAH to the Pharmaceuticals and Medical Devices Agency (PMDA) for review and approval. Cobridge thus represents the applicant from the time of application and takes care of the application until approval, including acting as the PMDA correspondent. Toward the end of the review cycle, the applicant will need to prepare an application for NHI reimbursement. Cobridge is well positioned from its experience and capabilities to prepare such applications, and has done so for many clients. Thus Cobridge can cover all of the required activities associated with obtaining marketing approval for a medical product, from gap-analysis and preparation of the approval dossier (see the associated pages on this website), through shepherding the application through the review and approval process by the PMDA and obtaining NHI reimbursement, to performing the regulatory-compliance maintenance activities as the ongoing DMAH for the approved product.
During review and approval for those medical products, especially for medical devices where foreign clinical investigations may often be used in support of an approval application, but also for pharmaceuticals where foreign clinical studies are considered pivotal when buttressed by bridging studies, Cobridge can also perform an essential task associated with acceptance of foreign clinical studies by the PMDA. Cobridge prepares and submits documentation in support of the overseas clinical study’s GCP compliance to the PMDA for a Compliance Review. This involves collecting information regarding the study in general, as well as detailed information for each of the participating clinical sites. Much of this information is not present in the typical package of registration materials supplied for foreign registrations. Gathering the information from diverse sources often involves some communications effort with the foreign firm. Beyond the application preparation and submission, there is also a need to conduct verification of data contained in the clinical database against case report forms, and confirmation of information in the study report against data in the clinical database (this latter goes beyond compliance matters to those involved in review of safety and effectiveness by the PMDA). The PMDA’s focus with regard to compliance is somewhat different from that of the U.S. FDA’s, and even clinical studies that have passed muster with FDA’s Biometrics inspectors have not infrequently had certain inconsistencies that need to be rectified or risk-managed lest they become a show-stopper during the PMDA Compliance Review. Our experience encompasses PMDA Compliance Review of clinical studies submitted by major foreign medical device manufacturers in support of Japanese approval applications.