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/pharmaceutical-solutions/strategic-and-regulatory-consulting/national-health-insurance-pricing
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
- 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.
- 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:
- Providing strategic Japan market access consulting for planning and execution for Japan Market Entry
- CMIC Group is the only company in Japan that can offer MAH partnering for orphan drugs as we have Orphan Pacific Inc., a pharmaceutical company with manufacturing and marketing authorization licenses, as a part of our group.
- In-Country Clinical Caretaker Services (ICCC)
- Marketing Authorization Holder (MAH)
CMIC provides comprehensive support for pharmaceutical‑related companies entering and expanding their business in the Japanese market from the early stages. Through market analysis (including competitive analysis, market research, and Target Product Profile (TPP) development), grant application support for public funding, and the planning and execution of exit strategies such as licensing‑out, we help maximize overall business value.
In this context, we support decision‑making that determines market entry viability (Go/No‑Go) and defines a winning strategy, ensuring a seamless transition to the subsequent execution phase through the following six key elements.
Six Key Elements Supporting Pre‑Entry Decision‑Making:
- Market Analysis
We assess the market landscape, competitive environment, and entry barriers to identify opportunities and refine winning hypotheses in the Japanese market. - Business Feasibility Assessment
We evaluate in‑licensing opportunities and overall business feasibility by visualizing key success conditions, major risks, and decision points. - Business Strategy Development
Leveraging our extensive experience in supporting public funding and grant applications, we design application strategies and clarify key discussion points. Where appropriate, we also structure investor‑focused considerations, and develop executable market entry and expansion strategies as well as exit strategies, including licensing‑out. - Development Strategy
We design an integrated development roadmap aligned with the Japanese market, including early‑stage development strategies, defining development steps and priorities. - TPP Development Support
We establish the TPP as a shared communication framework, accelerating decision‑making across development, business, and partnering activities. - Partnering Strategy
In line with the selected market entry options, we structure partnering approaches by clarifying partner profiles, optimal timing, and key discussion points.
- Japan Business Strategy Consulting
- Market Value Estimation
- Clinical Development Strategy Consulting / Regulatory Affairs Consulting
- Consulting for Pharmaceutical Business License in Japan
- In-Country Clinical Caretaker (ICCC) Services
- Marketing Authorization Holder (MAH)
- Investigational Product Manufacturing
- Clinical Operations
- Clinical Site Network Services / Med Concierge service
- Pharmacovigilance
- Sales & Marketing
- Medical Affairs
- Medical Device Development
- Orphan Drug Development
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!
Podcast | Executive Insights on Accelerating Drug Development and Market Access in Japan & Asia-Pacific
Featuring: Keiko Oishi, President, CMIC Group
As Japan continues to address long-standing challenges such as drug lag and drug loss, global pharma and biotech leaders are re-evaluating how—and when—to include Japan and APAC in their development strategies. In this timely conversation, Mrs. Oishi explains how policy shifts, regulatory flexibility, and regional convergence are reshaping global development timelines.
- How Japan’s regulatory environment is evolving through 2026
- Why Japan and South Korea are becoming strategic extensions of Western development programs
- The value of a fully integrated service model
- Key cultural, regulatory, and operational considerations
- Long-term opportunities and challenges in Asia-Pacific
“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.
