The Improving Japanese Pharmaceutical Regulatory Environment

There are new concerns arising in Japan around drug pricing. Last April, the Japanese government introduced a re-pricing rule for “huge seller drugs” and proceeded to slash the reimbursement price for Gilead’s Solvaldi by a hefty 30%. The concern now among industry executives is that the government may continue to introduce these ad-hoc re-pricing rules on other strong selling drugs, in essence penalizing manufacturers for success.

Although they are facing headwinds over NHI pricing, multinational and Japanese companies must acknowledge the improving regulatory environment evidenced by changes made by the Pharmaceuticals and Medical Devices Agency (PMDA) over the past 10 years resulting in greatly improving the speed of new drug reviews and approvals. According to recent statistics, the average number of days between NDA filing and approval of a standard drug in Japan is now at 306 days, compared to 322 days in the US (FDA) and 366 days in the UK (MHRA). For orphan drugs, the PMDA is reviewing and approving such agents in approximately 6 months from the time of filing. In addition, as one of the signees of the International Council on Harmonization (ICH), Japan and specifically the PMDA are supportive of efforts to harmonize preclinical and clinical studies to reduce the redundancy of studies already completed in other areas of the world. This is evident by the increasing number of global studies which include sites in Japan.

A big reason for the improvements seen at the PMDA are a result of the various types of consultations available to pharmaceutical sponsors throughout the drug development process. The PMDA has vastly increased the number of reviewers over the past years, the cost of which paid mostly by the pharmaceutical industry through “user fees”. Compared to the 1990’s when the Japanese agency (then known as “KIKO”) was understaffed and much more conservative when it came to optimizing Japanese timelines, the situation today is greatly improved for pharmaceutical manufacturers operating in Japan.
However, even western biopharma companies who do not have a presence in Japan can take advantage of this system. In the past, sponsors wanting to hold a meeting with the regulatory agency had to have a physical presence in the country. Today, a US or EU company can engage a local regulatory advisor to act as “In-Country Caretaker” who will represent the sponsor in all types of consultations available through the PMDA.

Western biopharmas will want to consider the following when thinking about approaching the PMDA regarding a consultation meeting:

  •  Is your drug considered a regenerative medicine product? Under new regulations established in November 2014, consultations for regenerative medicine products (e.g. cell-based products, gene therapy) now go through a different process than standard molecules. The PMDA will want to first hold consultations to discuss the manufacturing (CMC) and non-clinical/safety aspects of the drug. Only once these meetings have been held, and a successful result obtained, can companies then hold a consultation to determine the clinical pathway in Japan for the regenerative medicine product.
  • Companies should also keep in mind that the PMDA will want to first hold an informal meeting with the sponsorprior to holding the official, formal consultation. The informal meetings are typically 30-40 minutes, and there are no user fees owed to the agency. There are also no formal minutes of the informal meetings issued by the PMDA. The primary objective of the informal meeting to to obtain guidance from the agency on the consultation topics which are to be discussed at the formal meeting. The formal meetings last approximately 2 hours, and offer opportunity for the regulatory and development people of the western sponsor to have a direct discussion with the agency about the key points that will impact the development and ultimate approval of their product in Japan. The formal meetings also allow the opportunity to have simultaneous translation (a booth for interpreters is available at the formal meetings). The PMDA will charge user fees for the formal meeting, and will also issue minutes within 1 month of the meeting.

Western biopharmas who are interested in gaining insight on the Japan regulatory pathway for their drugs have many opportunities to do so through the continually-improving PMDA. At Locust Walk, we assist numerous clients with preparing for and executing successful consultations at the PMDA. Please contact us for more information at

SEngen_website Written by Steve Engen