Cobridge has the most comprehensive set of DMAH licenses available, and is therefore able to act as DMAH for any medical product that can be marketed in Japan.
The company’s DMAH licenses allow it to handle medical devices (Class II though Class IV), including in vitro diagnostics (IVDs), Companion Diagnostics (CDx), biologics, and combination products. Cobridge’s DMAH licenses cover products known in Japan as “quasi drugs”.
The DMAH System in Japan
For those overseas medical product companies that are unfamiliar with the Japanese DMAH system, a brief overview is presented here, and this is followed by an introduction to the competitive advantages of using an independent DMAH such as Cobridge for an overseas medical products firm when marketing its products in Japan.
The Japanese Pharmaceutical Affairs Law (PAL) was amended in the early years of the new millennium. Prior to the amendment, there was no DMAH system, and a foreign medical products firm had two options for marketing its products in Japan. On the one hand, the firm could license its product to a domestic manufacturer and allow the domestic manufacturer to obtain either manufacturing approval or import approval for it. On the other hand, the firm—if it was the product’s manufacturer—could obtain a foreign manufacturing approval, and then a Japanese importer-distributor, based upon information about the approval supplied by the foreign manufacturer, could obtain “import permission” from the health ministry. The foreign manufacturer would use an in-country caretaker to handle correspondence with the health ministry. (Domestic medical products firms, likewise, had to obtain manufacturing approval in order to market their own medical products in Japan.) In other words, the legal framework was based upon the assumption that the products’ physical manufacturer (or importer, in the case of import approval) would be making applications for marketing authorization, and marketing authorization approvals for medical products were manufacturing-based approvals, not product approvals per se. Under this previous system, if a foreign (or domestic) firm relied upon contract manufacturing—for example, a medical device firm that essentially is a specification developer or a venture capital biopharmaceutical firm—it could not obtain marketing authorization, itself, for its products in Japan.
With the PAL amendments, which came into full force in 2005, foreign medical product companies could freely choose an MAH—a Designated MAH or DMAH—to perform the necessary regulatory-compliance obligations for the imported product. Most important, the DMAH need not be the Japanese distributor, thus breaking the previous entanglement of business matters relating to distributor arrangements from the regulatory-compliance obligations for the medical product.
This has important implications for overseas medical products producers wishing to export to the Japanese market.
Multifaceted Roles of the DMAH
Post-approval activities of the DMAH fall into two categories, Good Quality Practice (GQP) for drugs and quasi-drugs, Quality Management System (QMS) for medical devices and IVDs and Good Vigilance Practice (GVP), both of which are defined in the PAL and associated regulations (ministerial ordinances). GQP and QMS relates to the monitoring of product quality, including batch release in Japan and any product complaints from the field. GVP relates to pharmacovigilance activities. Thus, the gamut of post-approval activities performed by Cobridge in its role as DMAH include (a) serving quality assurance duties for product release in Japan upon execution of a GQP or QMS agreement with the Japanese importer licensed as a labeling, packaging and storage manufacturer, (b) performing post-marketing safety surveillance duties for the product in Japan upon execution of GVP agreements with the Japanese importer-distributor, (c) serving as the PMDA contact concerning the product, (d) monitoring gazetted notifications and pronouncements from the MHLW that relate to the product, (e) collecting and relaying legally required information regarding the overseas medical products firm (changes in executive management, changes in particulars regarding the manufacturing plant, etc.) to the PMDA, (f) coordinating the reporting of foreign safety reports to the PMDA and MHLW, and (g) preparing and filing initial and follow-up safety reports, and annual reports to the MHLW for adverse events that occur in Japan.