Japanese Legislation for Accelerating Drug Development

Watch our free webinar to learn about the new legislations introduced by Japan’s Health Ministry, which aim to support fast-track opportunities for orphan and innovative drugs for UK companies in Japan’s pharmaceuticals market.

As one of the largest global pharmaceutical markets, Japan’s regulatory authority, Pharmaceuticals and Medical Devices Agency (PMDA) introduced several new legislations for accelerating drug development. Dr Gemba from Integrated Development Associates Co Ltd (IDA) will introduce the following three key legislations and how to utilise them for fast approval and access to Japan’s pharmaceutical market.

Sakigake (Forerunner) Initiative

In 2014 Japanese Ministry of Health, Labour and Welfare (MHLW) promulgated new regulations known as “SAKIGAKE” (or the “Forerunner Initiative”).  This initiative allows dramatically accelerated regulatory pathways for drugs designated as breakthrough therapies addressing high, unmet medical needs with the additional condition that companies initiate early development and seek initial product approval in Japan.

Expedited Approval for Regenerative Medicines

With the intent of maintaining Japan’s position as the world leader in the development of regenerative medicine, such as cell therapy and gene therapy products, MHLW and PMDA have issued policy guidance laying out a unique and accelerated regulatory pathway for regenerative therapies.

Orphan Drug Designation (ODD)

Japan’s commitment to promoting the development of and facilitating patient access to new therapies for rare diseases is one of the strongest in the world. IDA has extensive experience in assisting clients in gaining Orphan Drug Designation (ODD) from MHLW as well as in obtaining development subsidies from the National Institute for Biomedical Innovation (NIBIO).

Benefits of Attending the Webinar

UK biotech and pharmaceutical companies will learn about the assistance available to them for possible fast track entry into the Japanese market.

About the Speaker

Kaori Arai, Senior Trade Adviser for Life Sciences at UKTI Japan will host the webinar.

Dr Takefumi Gemba, Senior Vice President, Head of Product Development, Integrated Development Associates Co Ltd. will deliver the presentation and be available for a live Q and A session at the end of the webinar.

Dr Gemba has over 25 years of experience in all phases of drug development, from drug discovery to clinical trials and NDA submission, in a diverse range of therapeutic fields including neurology, cardiovascular, allergy, inflammatory, oncology and metabolic disease areas. After graduating from Osaka University in 1990 with M.S. in Neurochemistry, Dr Gemba entered Shionogi Co Ltd as a research scientist in the field of cardiovascular pharmacology. In 1995, he completed his PhD in the fields of Neurochemistry and Cardiovascular Pharmacology and continued his work at Shionogi, where he led several projects as Group Leader in the Immunology, Inflammatory, and Bone and Joint Group.

Dr Gemba joined IDA in 2013 and is responsible for overseeing all regulatory and scientific interactions with PMDA and MHLW, as well as IDA’s Clinical Trial In-Country Caretaker and Marketing Authorization Holder activities.

About the IDA

Integrated Development Associates Co Ltd (IDA), founded in 2004 and a member of the M3 Group since March 2015, is a Japanese company that provides consulting, CRO and IT driven solutions that enable the optimal development and commercialisation of novel biopharmaceutical products for Japan and Asia. IDA’s unique business model enables companies to increase the value of their products through intelligent product development planning, accelerated clinical trial implementation and effective marketing strategies.

The IDA’s main areas of focus are:

  • Market, medical and regulatory strategy
  • Comprehensive management of clinical development
  • Commercialisation support and partnering

For more information, please see the IDA’s webite: https://www.i-d-a.com/

The webinar slides will be available for download shortly.


Contact Kaori and her expert team to learn more about the life sciences market in Japan.

This webinar was recorded on 18 November 2015.

Japanese Legislation for Accelerating Drug Development Webinar Slides