Japan Market Entry

Work with CMIC’s Experts for Optimized Success for Japan Market Entry

Benefits of the Japan Pharmaceutical Market: Ensuring Japan Market Entry Success

CMIC Group provides comprehensive support for companies looking for Japan market entry, specifically in pharmaceuticals. Our services span across various stages of the drug development and commercialization process, ensuring a smooth and successful market entry. By leveraging our extensive experience and network in Japan, companies can effectively navigate the complexities of the Japanese pharmaceutical market, ensuring compliance, minimizing risks, and maximizing their chances of success.

If you wish to conduct a clinical study in Japan, we can serve as the required In-Country Clinical Caretaker (ICCC). If you want to commercialize a new product, we can act as the Marketing Authorization Holder (MAH) or connect you with a strategic licensing partner. Our experienced consultants can help you determine the best strategy in accordance with Japan-specific changing regulations and unique environment, with options for entry at any stage in drug development: before clinical trials have started abroad, after approval abroad or after commercialization in a different country.

Values and Potential of the Japanese Pharmaceutical Market

  • The world’s third largest pharmaceutical market after the U.S. and China.
  • New modality is well accepted compared to other regions with good relationship and communication between investigators and patients.

Universal Health Insurance System: Due to the unique system, every citizen has equal access to the necessary and high quality medical treatment by paying only a certain percentage of the medical cost from his/her own pocket.

Price Listing of New Drugs: The timing of price listing is four times per year (Feb, May, Aug, and Nov) for new drugs. New drugs are listed in the NHI price list within 60 days after marketing approval in principle, within 90 days at the latest. For more info on NHI price listing, please visit: https://en.cmicgroup.com/solutions/national-health-insurance-pricing

Japan Market Entry Access

Navigating the Regulatory Landscape in Japan and it’s Advantages

Rapid Approval

  • Faster approval time than FDA – Approvals are in many cases faster than in other regulatory authorities. A recent study showed that the PMDA had the shortest median approval time and the shortest interquartile range for the approval of new active substances between 2013 and 2022, ahead of the U.S. FDA.
  • Comparable approval time with FDA in both expedited and standard reviews with the smallest difference in between review types

Rapid Approval Evidence: “New active substance (NAS) median approval time for six regulatory authorities in 2013-2022

Regulatory Systems in Japan: Discussions with PMDA will become smoother by incorporating Japan into global trials.

High Quality Data: Consistent and high quality clinical data derived from scientific knowledge and highly compliant characteristics of investigators and patients

Step by Step Guidance for Japan Market Entry

CMIC’s comprehensive support with an option of Marketing Authorization Holder (MAH), is a unique service that no other company can offer

  1. Establish a subsidiary in Japan: Establish a Japan office with Pharma Business Licenses in Japan and submit NDA, negotiate drug price, sales/marketing, distribution, pharmacovigilance/safety responsibilities as a local pharma company.
  2. License out to other pharma: License Japan business right to a Japanese company to be MAH and submit JNDA, negotiate drug price, distribute and sell product under license agreement.
  3. Assign Marketing Authorization Holder (MAH): Assign Japanese pharma company as MAH which submits NDA and negotiates drug price. Assigned company provides service as designated MAH role such as sales, distribution, pharmacovigilance/safety responsibilities.

How CMIC Group will Support Your Japan Market Journey:

OrphanPacific, Inc. is a pharmaceutical company within CMIC Group, with manufacturing and marketing authorization licenses which can be MAH of your orphan drugs in Japan.

Talk to our expert about MAH partnering!

PMDA Opens the Door to Innovative Products in Japan”

Learn what the PMDA (Pharmaceuticals and Medical Devices Agency) of Japan has to say about the unique benefits of the Japan Pharmaceutical Market and the countless opportunities to sponsors developing innovative therapeutic products in Japan.  Read the full article on DIA’s website by clicking the button below.

Resources

  • C-CAST: In-Country Clinical Caretaker (ICCC) for Clinical Trials in Japan

Oncology Drug Development
Oncology Drug Development

Have inquiries about our services or are you interested in outsourcing your operations to us?

Commercial

Comprehensive Sales and Marketing Support
Human Resources Solutions for MR
Remote Communication Support
Training/Assessment

Medical Affairs

MA Consulting
Operational Support
Human Resources Solutions for MA/MSL
MA/MSL Training

Patient Solutions

Patient Support Programs
Nurse Educator