Japan’s PMDA

Medical Device/IVD

Pharmaceuticals

Cosmetics & Quasi-Drugs

Food Supplements

Market Accelerated Access for Health Products

Japan’s regulatory framework restricts market access for foreign companies that do not have an established corporate entity within the country. To sell pharmaceutical products in Japan, a foreign company must designate a local Marketing Authorization Holder (MAH) accredited by the Pharmaceuticals and Medical Devices Agency (PMDA). Approval to register and market products is contingent on assigning a qualified MAH.

Requirements for Foreign Manufacturers

Foreign manufacturers must designate a Marketing Authorization Holder (MAH) to legally market medical devices and IVDs in Japan. The designated MAH ensures compliance with Japan’s regulatory requirements and manages product registration, post-market activities, and communications with regulatory authorities.

For medical devices, Japan also allows for the appointment of a Designated Marketing Authorization Holder (DMAH). However, this designation does not apply to pharmaceuticals, which require an MAH exclusively.

GRP-Japan: Your Partner for Regulatory Compliance

Global Regulatory Partners Inc. (GRP) is a licensed Marketing Authorization Holder (MAH) in Japan. With a dedicated team of local regulatory experts based in Tokyo, we provide comprehensive support to foreign manufacturers, helping them navigate Japan’s complex regulatory environment.

Regulatory & Market Access Services

Navigating Japan’s Regulatory System for Pharmaceutical Products

Navigating the regulatory system in Japan can be challenging, as the country has its own unique set of regulations, procedures, and customary business practices. To successfully gain approval for your pharmaceutical product, defining an effective and efficient regulatory strategy is essential.

Global Regulatory Partner GK’s Regulatory Team in Japan has extensive experience working with the Pharmaceuticals and Medical Devices Agency (PMDA) and within Japan’s regulatory framework. Our team is well-equipped to help you develop a tailored strategy that ensures compliance while minimizing delays and costs.


How We Help You Succeed:

  1. Identify the Latest Regulatory Requirements

    • We continuously monitor and assess updates to Japan’s pharmaceutical regulations to ensure your product meets the most current requirements.
  2. Proactively Address Potential Challenges

    • Our team identifies potential obstacles that could delay the approval process, providing solutions before they escalate into major issues.
  3. Assess and Mitigate Risks

    • We conduct a thorough risk assessment to pinpoint regulatory risks and unexpected roadblocks that could arise during the registration process, helping you avoid costly delays.
  4. Propose Innovative Solutions

    • We develop creative, proactive strategies to address challenges, ensuring your product progresses smoothly through Japan’s regulatory system.
  5. Identify Cost-Effective Registration Pathways

    • Our team evaluates all available registration options and selects the most efficient and cost-effective strategy to bring your pharmaceutical product to market quickly ahead of time.
    • Identify the most cost-effective way to get your drug registered in Japan.

The Importance of Pre-Consultation Meetings with PMDA and MHLW

When developing new pharmaceutical or biologic products, it is highly recommended to schedule a pre-consultation meeting with Japan’s health authorities, including the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW).

These consultation meetings are a valuable tool for sponsors to:

  • Discuss product-specific challenges and development needs
  • Review the design and scope of proposed nonclinical studies
  • Present and refine the Chemistry, Manufacturing, and Controls (CMC) development plan
  • Align on the overall development strategy to ensure a smoother regulatory process

GRP’s Regulatory Affairs Team Support Services

Our team provides comprehensive support to help you prepare, execute, and follow up on these critical meetings:

  1. Writing and Preparing the Meeting Package:

    • Develop a complete meeting package tailored to the development stage and regulatory requirements of your product.
  2. Submission of the Meeting Package to Health Authorities:

    • Handle the timely submission of all meeting-related documentation to the PMDA or MHLW.
  3. Preparing Key Questions:

    • Formulate relevant questions for the health authorities based on the current status and future plans of your product’s development.
  4. Providing Meeting Support:

    • Assist you during the consultation meeting by addressing key topics and ensuring productive discussions.
  5. Writing Meeting Minutes and Action Plan:

    • Document key takeaways and outcomes, then develop an actionable plan to implement feedback and next steps.

Accredited Foreign Manufacturer (FMA) Certification for Drug Importation in Japan

Foreign pharmaceutical companies seeking to import their drugs into Japan must obtain certification from the Ministry of Health, Labour and Welfare (MHLW) as an Accredited Foreign Manufacturer (AFM). Previously known as Foreign Manufacturer Accreditation (FMA), this certification is a critical requirement for entering the Japanese market.

An FMA number is a necessary component of the Product Dossier Submission and is required for each manufacturing site involved in the production of the drug.


Preparation and Submission of the FMA Application

To become accredited, a foreign manufacturer must prepare and submit an AFM application to the Pharmaceuticals and Medical Devices Agency (PMDA) for review and approval. An application is required for each manufacturing site.

Key Components of the FMA Application:

  1. Business Number and Serial Code (Gyosha):

    • A unique identifier assigned to each manufacturing establishment.
  2. Self-Declaration of Medical Condition (Someisho):

    • Declaration of the health status of the senior manager representing the manufacturer.
  3. Personal History of the Responsible Person:

    • The background and qualifications of the individual responsible for the manufacturing facility being registered.
  4. Visual Documentation of the Manufacturing Site:

    • Detailed pictures, drawings, floor plans, and other documentation showing the building(s) within the scope of registration.

NDA Dossier Preparation and Submission in Japan

Bringing a new drug to Japan requires meticulous planning and compliance with the stringent regulations of the Pharmaceuticals and Medical Devices Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). With years of expertise, Global Regulatory Partners (GRP-Japan) offers comprehensive services to ensure the smooth preparation and successful submission of your New Drug Application (NDA) dossier in Japan.


Our End-to-End NDA Dossier Services Include:

  1. Regulatory Strategy Development:

    • We analyze the specific regulatory requirements for your product and develop an optimal strategy to minimize risks and delays.
    • Assess the need for bridging studies or expedited approval pathways (e.g., Priority Review, Sakigake).
  2. Dossier Preparation Using the ICH CTD Format:

    • Our experts compile and organize the necessary documentation following the Common Technical Document (CTD) structure:

    • Module 1: Regional Administrative Information

    • Module 2: Summaries of nonclinical, clinical, and quality data

    • Module 3: Quality documentation (CMC data, manufacturing processes, GMP compliance)

    • Module 4: Nonclinical study reports

    • Module 5: Clinical study reports and results, including bridging studies (if required)

  3. Drug Master File (DMF) Submission:

    • We help prepare and submit the DMF for Active Pharmaceutical Ingredients (APIs), ensuring compliance with PMDA requirements.
  4. CMC Documentation:

    • Ensure that all Chemistry, Manufacturing, and Controls (CMC) data meet Japan’s regulatory expectations.
    • Collaborate with manufacturing sites to provide accurate process descriptions and quality control details.
  5. Translation of Submission Materials into Japanese:

    • Translate key documents (technical files, safety reports, CMC sections) to meet the PMDA’s requirements for Japanese-language submissions.
  6. GMP Compliance Support:

    • Coordinate GMP inspections and help manufacturing sites address any findings before dossier submission.
  7. Pre-NDA Consultation Support:

    • Assist with meetings with the PMDA to clarify expectations, regulatory pathways, and requirements for the NDA.
    • Prepare meeting packages, key questions, and post-meeting action plans.
  8. Dossier Submission to PMDA:

    • Handle the electronic and physical submission of the complete dossier, ensuring it meets all formatting, content, and technical requirements.
  9. Responding to PMDA Inquiries:

    • Provide timely responses to questions or data requests from the PMDA during the review process.
    • Address additional documentation requirements to avoid delays.
  10. Post-Approval Planning:

  • Develop plans for post-marketing surveillance (PMS), including adverse event monitoring and risk management programs.

Benefits of Partnering with GRP-Japan:

  • Local Expertise: Our regulatory team in Tokyo has an in-depth understanding of PMDA processes and requirements.
  • End-to-End Solutions: From regulatory strategy to post-approval compliance, we handle all aspects of the NDA process.
  • Minimized Delays: By proactively addressing potential risks and challenges, we help expedite your product’s approval timeline.

Typical NDA Timeline with GRP Support:

  • Pre-NDA Consultation & Planning: 6 months
  • Dossier Preparation & Submission: 12–18 months
  • PMDA Review & Approval: Varies based on product complexity and regulatory pathway

Market Access for Foreign Companies in Japan

GRP-Japan’s Regulatory Strategy Services

We provide a comprehensive suite of services designed to help you stay ahead of regulatory challenges:

  • Identifying the Latest Regulatory Requirements: We ensure you stay informed of Japan’s constantly changing regulations related to your medical device or IVD.
  • Proactively Addressing Potential Challenges: Our team identifies possible issues that could delay product approval and helps resolve them early.
  • Risk Assessment and Mitigation: We assess potential risks and obstacles during the registration process, helping you avoid unexpected setbacks.
  • Innovative Solutions for Regulatory Challenges: GRP develops creative, proactive strategies to overcome regulatory roadblocks before they impact your timeline.
  • Cost-Effective Registration Pathways: We propose efficient, budget-friendly strategies to streamline product registration and reduce costs wherever possible.

With GRP-Japan as your partner, you gain access to in-depth regulatory knowledge and practical expertise, ensuring a smooth and efficient pathway to market entry. Let us help you navigate Japan’s regulatory landscape and achieve success with minimal risk and optimal results.

Pre-Market Requirements for Medical Devices and IVDs in Japan

Before legally selling a medical device or in vitro diagnostic (IVD) product in Japan, companies must ensure compliance with the regulatory requirements established by the Pharmaceutical and Medical Device Agency (PMDA) and the Ministry of Health, Labour and Welfare (MHLW). A critical step in this process involves correctly determining the device’s classification and product code.

Importance of Proper Classification

The classification of a medical device dictates the regulatory pathway it must follow for registration. Proper classification ensures that the correct submission process is initiated and reduces the risk of delays due to regulatory missteps. Japan uses its own Japan Medical Device Nomenclature (JMDN) system to assign classification and product codes to devices, making it essential to identify these accurately from the outset.

PMDA Consultation Meetings: A Key Step in Product Development

Consultation meetings with the Ministry of Health, Labour and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) are invaluable for medical device sponsors. These meetings provide an opportunity to discuss product-specific development needs and challenges, including the design of nonclinical studies, Chemistry, Manufacturing, and Controls (CMC) plans, and overall development strategy.

The Global Regulatory Partners Inc. (GRP) regulatory affairs team in Tokyo has extensive experience organizing and supporting PMDA consultation meetings, ensuring sponsors are fully prepared to address key topics and milestones during product development.

GRP-Japan’s Regulatory Support for PMDA Consultation Meetings

We provide end-to-end support for organizing and executing productive consultations, helping sponsors navigate the regulatory process smoothly and efficiently. Our services include:

  • Writing and Preparing the Meeting Package:
    • Compile and submit a comprehensive meeting package tailored to the development status of your product.
  • Drafting Key Questions:
    • Formulate targeted questions for PMDA based on your product’s current development stage and future milestones.
  • Pre-Meeting Preparation:
    • Ensure sponsors are well-prepared to present their development plan, nonclinical study design, and CMC details effectively.
  • Providing On-Site or Virtual Meeting Support:
    • Offer guidance and support during the meeting to address any concerns raised by PMDA and facilitate smooth discussions.
  • Documenting Meeting Minutes:
    • Prepare detailed meeting minutes, capturing key decisions and discussions for future reference.

Clinical Trial Management and Patient Recruitment in Japan

In today’s challenging regulatory and operational environment, conducting successful clinical trials requires a combination of therapeutic expertise, regulatory knowledge, and operational efficiency. At Global Regulatory Partners Japan (GRP-Japan), our professionals ensure that clinical studies for medical devices and in vitro diagnostics (IVDs) comply with ICH guidelines and the regulatory requirements of PMDA and MHLW.

We have developed proven strategies to address key challenges, including patient recruitment and retention, site identification, and risk mitigation. Our experience allows us to provide access to the most suitable clinical sites and patient populations, ensuring trials are conducted smoothly and efficiently.

Why Choose GRP-Japan for Your Clinical Trials?

Our team has helped numerous companies conduct successful clinical trials by delivering tailored solutions that optimize trial performance and minimize delays.


Comprehensive Clinical Trial Services:

  • Protocol Development: Design and develop trial protocols that comply with regulatory guidelines and clinical objectives.
  • Site and Investigator Identification and Qualification: Identify and qualify suitable clinical sites and investigators with access to target patient populations.
  • Site Initiation and Training: Ensure that trial sites are properly trained and equipped to meet study requirements.
  • Clinical Monitoring: Conduct regular site monitoring visits to ensure protocol adherence and data quality.
  • Medical Monitoring: Provide ongoing medical oversight to address safety concerns and ensure patient well-being.
  • Data Safety Monitoring Board (DSMB) Coordination: Manage and coordinate DSMB activities to monitor data safety and efficacy.
  • Statistical Analysis: Perform comprehensive statistical analysis to support clinical outcomes.
  • Electronic Data Capture (EDC): Implement EDC systems to collect, track, and manage clinical trial data efficiently.
  • Electronic Trial Master File (eTMF): Maintain an organized and compliant eTMF for regulatory submissions and audits.
  • Full-Service Data Management: Provide data collection, cleaning, and database lock services.
  • ClinicalTrials.gov Registration and Management: Ensure accurate trial registration and ongoing updates.
  • Central Lab Oversight and Coordination: Oversee lab activities and ensure sample handling and processing comply with trial protocols.
  • Site Quality Assurance Audits: Conduct site audits to ensure compliance with GCP and trial protocols.
  • Integrated Final Clinical Study Report: Prepare a comprehensive final report summarizing clinical data, safety outcomes, and key conclusions.

 

Key Steps in the Registration Pathway

  1. Assign an MAH or DMAH: The first requirement for foreign manufacturers is to designate a local Marketing Authorization Holder (MAH) for pharmaceuticals or Designated Marketing Authorization Holder (DMAH) for medical devices. The appointed entity will act on your behalf to manage compliance and regulatory submissions.

  2. Determine Device Classification and JMDN Code: The classification of your medical device or IVD will determine the complexity of the registration process. Japan classifies devices into categories based on risk levels, with varying documentation and regulatory approval processes for each.

  3. Choose the Appropriate Registration Path: The device’s classification will determine whether it requires a Pre-Market Submission (Todokede), Pre-Market Certification (Ninsho), or Pre-Market Approval (Shonin). Understanding this pathway is crucial to avoid delays and optimize the approval timeline.

  4. Comply with PMDA and MHLW Requirements: Prepare and submit the necessary regulatory documents, including test results, safety data, and manufacturing details. An effective regulatory strategy ensures that these submissions meet the requirements of both the PMDA and MHLW.

  • Act as your Market Authorization Holder (MAH)
  • Determine classification of your device
  • Help you determine the proper regulatory pathway for your device
  • Inform you of the documentation required within the applicable registration route.
  • Help you determine a grouping strategy for your registration
  • Prepare and submit registration application documents to PMDA
  • Coordinate translation of submission materials into Japanese
  • Work to answer questions from PMDA during the submission process
GRP Japan has helped many companies register successfully their medical devices and IVDs products in Japan.

Market Access for Cosmetics in Japan

Comprehensive Regulatory and Market Authorization Services in Japan

Global Regulatory Partners Inc. (GRP) offers end-to-end regulatory solutions to help companies navigate Japan’s complex regulatory landscape and successfully bring their products—including medical devices, IVDs, and cosmetics—to the market. As a licensed Marketing Authorization Holder (MAH), GRP ensures regulatory compliance, product registration, and post-market management, allowing you to focus on expanding your market presence.


Our Core Services in Japan:

1. Market Authorization Holder (MAH) Services:

  • Act as your official MAH in Japan, managing product registration, compliance, and post-market surveillance in accordance with the Pharmaceuticals and Medical Devices Act (PMD Act).
  • Provide ongoing support for regulatory updates and market entry.

2. Regulatory Intelligence:

  • Monitor and analyze evolving regulatory requirements from PMDA, MHLW, and other relevant authorities to ensure timely compliance.
  • Provide insights into Japan-specific requirements for cosmetics.

3. Regulatory Strategy:

  • Develop tailored regulatory strategies based on product classification, intended use, and risk level.
  • Identify the most efficient pathways for registration to minimize time and cost.

4. Regulatory Affairs Management:

  • Prepare and submit regulatory documentation to authorities.
  • Assist with consultations, inspections, and audits to ensure smooth approval processes.

5. Product Registration:

  • Manage the complete registration process for cosmetics in compliance with Japanese regulations.
  • Provide classification and formulation reviews to ensure accurate and efficient registration.

6. Cosmetic Packaging and Labeling Review:

  • Ensure packaging and labeling meet MHLW requirements for cosmetics sold in Japan.
  • Verify claims, warnings, and ingredient disclosures are compliant with Japanese standards.

7. Product Classification and Formulation Review:

  • Accurately classify your product according to Japanese regulatory categories, such as cosmetics, medical devices, or IVDs.
  • Review formulations to ensure compliance with approved ingredients and concentrations.

8. Importation and Warehousing:

  • Manage the importation process, ensuring products meet customs and regulatory requirements.
  • Provide warehousing solutions in licensed facilities, ensuring proper handling and storage.
  • Product Release and Traceability in Japan’s territory.