For drug companies planning development in Japan, consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) are a practical way to align your strategy with the Japanese health authority’s expectations before you commit to costly studies and other market entry issues in Japan. The PMDA consultation services provide guidance and advice on clinical trials for drugs, data needed for regulatory submissions, and other matters.

Overview of PMDA consultations

The PMDA is not only reviewing completed data – it is willing to engage while you are still developing the plan, which can reduce the risk of rework later (for example, redesigning a pivotal study after PMDA “flags” specific concerns).

The PMDA has expanded and improved its consultation menu over time to meet varying development and submission needs, including those involving state-of-the-art technology. During clinical trial consultations for new drugs, the PMDA evaluates whether the proposed clinical trial program complies with its regulatory submission requirements by considering ethical and scientific aspects, the safety of trial subjects, and the reliability of the study. In general, the PMDA provides advice to facilitate improvement of the upcoming clinical trials. For example, if your pivotal strategy relies on a specific primary endpoint, this is the time to ensure those choices are appropriate and feasible in Japan.

Because all communication during the consultation process is in Japanese, the PMDA strongly recommends appointing a local Japanese Marketing Authorization Holder (MAH). Consultation meetings should be requested and arranged through the MAH as an intermediary. However, if you are requesting only the free pre-consultation meeting, having an interpreter, instead of the MAH, attend the meeting with you may be sufficient.

Notably, Japanese health authorities have recently relaxed the Japanese language requirement to create a more friendly regulatory environment for foreign sponsors. On a pilot basis, in late 2024, the MHLW announced that foreign drug makers without a presence or agent in Japan may submit applications for innovative drugs in English. In addition, the MHLW planned to establish a new consultation group to support MRCTs that include Japan, allowing foreign companies to communicate in English via meetings, email, and phone. To help U.S companies seeking to enter Japan, the PMDA opened a Washington, D.C. office with PMDA officers who can give guidance to companies interested in the PMDA consultation process.

Please note that there are a lot of common topics that do not fall under the scope of the PMDA consultation. Examples of this include pricing and reimbursement, patents, distribution/import, marketing license, etc.

The importance of PMDA consultation meetings

The PMDA highlights consultations as a mechanism where reviewers evaluate data on quality, efficacy, and safety in the pre-submission stage. Most importantly, the PMDA states that the consultation process constitutes part of the review once the application is submitted. This means that consultations are not merely advisory – they are integrated into the subsequent PMDA review pathway. That makes the quality of your PMDA briefing materials, the clarity of your questions, and your documentation especially consequential.

Pre-consultation meeting and Regulatory Science (RS) strategy consultation

The PMDA makes the sequencing clear – you have to apply for a pre-consultation meeting first before applying for the RA strategy consultation. These consultations provide advice on tests needed in early development and necessary clinical trials, spanning from the final stage of candidate selection through early clinical development up to proof-of-concept (Phase IIa).

Pre-consultation meetings

The stated purpose of the RS pre-consultation meeting is to organize the scope and points of discussion for a future efficient RS Strategy consultation and to confirm the content of materials.

In addition to technical experts from the Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), review staff of the review office in charge may be present as needed. Pre-consultation meetings are offered at no cost. However, no meeting minutes are prepared for the pre-consultation meeting. This means that you should not expect any answers to your specific questions during the pre-consultation meeting. Your goal should be to confirm that your intended questions are appropriate and framed clearly.

The RS pre-consultation meeting can be conducted face-to-face, online, or hybrid. A pre-consultation meeting lasts approximately 30 minutes and only accommodates at most 5 attendees. To apply for a pre-consultation meeting, an application form and other supporting materials should be sent via email to the Division of Innovation Support and Pharmaceuticals Affairs Consultations (R&D), Review Management Office. The PMDA staff will respond and notify you of your meeting schedule after around five business days.

RS strategy consultation

After the pre-consultation meeting, you can proceed with the RS strategy consultation, where the review team carefully checks documents submitted by the applicant and provides the PMDA’s official opinion with specific guidance and advice.

The RS strategy consultation is intended to help drug sponsors shape a development approach that is workable within Japan’s regulatory framework. In addition to product-specific strategy consultations, the PMDA provides guidance on general concepts for clinical study plans.

RS strategy consultation is generally intended for programs that have progressed beyond early discovery but are not yet fully mature. In other words, purely conceptual or exploratory research proposals are unlikely to be suitable. The program should also show reasonable potential for practical development. The PMDA highlights several priority drug areas, including oncology, orphan and intractable diseases, pediatric indications, regenerative medicine, and products involving innovative technologies.

Similar to the pre-consultation meeting, the RS strategy consultation can be conducted in person, online, or hybrid. However, applications for this consultation must be made well in advance of the consultation (more than 2 months in advance). Currently, the PMDA fee for an RS strategy consultation for drugs is listed as 1,541,600 JPY (around 10,000 USD).

Conclusion

A practical way to use PMDA’s consultation framework for drug registration is to approach it in stages. The RS pre-consultation meeting helps clarify scope and materials before moving to the paid RS Strategy Consultation. Together, this stepwise approach reduces risk and supports a smoother path for drug approval in Japan.