MBL

Frequently Asked Questions

• Why is MBL the partner of choice for companies seeking entry of their products and candidates into the Japanese healthcare market?

  We share the same mission as our partners: accelerating a quality product to market that can benefit patients. We consider it an honor to be entrusted with our partners projects, and we are committed to bringing our unique strengths to these projects:

  • Intimate knowledge of Japanese regulatory and NHI reimbursement processes, and a well-established workflow that navigates the intricacies of the Japanese healthcare system

  • Access to relationships with government organizations, KOLs, academic and research institutions, and other Japanese constituents necessary to bring medical products to market in Japan

  • A successful track record: In the IVD market alone, between February 2013 and September 2020, MBL launched more E3 IVDs (the most complex) in Japan than any other company

• How long does it take MBL to bring an IVD through the Japanese system?

  From product development to market, the entire process is usually takes 2 ½ – 3 years. MBL has been able to accelerate these timelines in certain circumstances, like with our MEBGEN™ RASKET Kit. In that case, a therapeutic drug already existed, and testing/diagnosis became necessary in order to optimize its use. We accomplished this in under 2 years.

• What kind of experience do you have with regulators and pricing authorities in the U.S., EU, UK and China? How does that global experience inform the way your work with partners seeking to launch an IVD in Japan?

  For any company today, meeting the needs of the global market is both an opportunity and a challenge. MBL is already familiar with the regulatory landscapes of the US and Europe, where they meet regulatory requirements. Through our collaborations with our parent company, JSR Life Sciences LLC, we will continue to build regulatory experience in those regions, as well as in China.

  Therefore, in working with partners who come to Japan, we understand that they must navigate multiple regulatory pathways. We know the range of data, requirements and other factors that our partners must consider when aiming at the global marketplace. Our goal is to streamline the partner’s processes in Japan, and our experience with global regulatory authorities ensures we can do that without placing undue burdens on the partner.

• At what stage of development should a company outside of Japan consider partnering with MBL?

  MBL can help at any point in the process, from identifying molecules and biomarkers in the lab, through the endstage reimbursement and commercialization processes within the Japanese health system. The earlier the partner brings MBL in, the more benefits we can provide to the process, making it more likely to achieve the desired outcome: speedy development and regulatory approval, along with commercial reimbursement.

• Can a company seeking to launch an IVD in Japan use clinical data gathered outside of Japan to support regulatory approval and NHI pricing? Or must the company gather that data in the Japanese population?

  Companies can use clinical performance data which were collected outside of Japan unless there were no differences in the test results among races. Clinical performance study is necessary if different test results are expected in Japanese. MBL can help partners conducting clinical performance study in Japan.

• Are there more needs for using test reagents other than in making disease diagnoses?

  The needs for test reagents are related closely to the medical advances and social trends as seen in the developments in genetic technology and other aspects of health and medical care. This means diagnosing a disease is just the beginning. MBL has the resources in place to help keep pace with the most advanced genetics insights informing diagnostics and treatment, which is one of the reasons we have been able to successfully launch more E3 IVDs in Japan than any other company.

• How does a company outside of Japan connect with MBL to discuss partnering opportunities with you?

  Please fill out the form below and we will follow up within 3 business days.