Japan

Medical Devices

Due to the rise of complex technologies and constant changing of regulatory environment regulatory professionals in the Medical Device Industry are facing more challenges. In addition to keeping up with these changes, regulators must also define the correct pathway for incoming registered products. Global Regulatory Partners Inc. (GRP) has a global presence with teams of local experts in Tokyo who can develop the appropriate regularly intelligence, strategy and pathway for the registration of your device in Japan’s market.

Authorized local agent

Authorized Local Agent in Japan (MAH)

Pharmaceuticals and Medical Devices Agency (PMDA) require all foreign Pharmaceutical and Biologic companies to assign a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) before registering and selling their products in Japan. In Japan, GRP Japan office is licensed by PMDA as a Category I MAH and can act as your MAH in Japan.

GRP-Japan MAH Services:

  • Communication with the PMDA
  • Assistance with PMDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support PMDA consultation meetings
  • Product registration
  • Product storage in an establishment with MAH licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization. Due to the continuously evolving nature of the Regulatory environment, it is becoming more challenging for regulatory professionals to stay up-to-date and collect the appropriate RI related to their product in a timely manner.

At Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence  for Japan that includes the latest  PMDA regulatory information and our recommendations for the most appropriate and effective strategy to address your particular- needs.

Regulatory Strategy

Defining the correct regulatory strategy is becoming very challenging as the regulatory landscape keeps changing constantly changing and new technologies are being introduced all the time. Following the correct regulatory strategy is crucial for Medical device companies during their product development through commercialization, as it helps them register their products successfully with MHLW and PMDA health authorities and bring them to the market with minimum risk. Global Regulatory Partners Inc. (GRP) team in Japan has helped many companies explore various regulatory options and develop optimal and efficient regulatory strategies for their medical devices and IVDs for Japan’s market.

GRP – Japan regulatory strategy services :

  • Identify and the latest regulatory requirements related to your medical device or IVD.
  • Proactively identify challenges or issues that may delay the approval of your medical device in Japan.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your medical product registered in Japan.

Regulatory Affairs

Global regulatory Partner, Inc. (GRP), provides a full regulatory affairs service in Japan from product concept product development and product registration.

Our regulatory affairs services in Japan include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with the PMDA and MHWL  authorities. Our Local Regulatory affairs team in Tokyo can  help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Product registration

Before legally selling a medical device on the Japanese market, it must comply with the regulatory requirements of the Pharmaceutical and Medical Device Agency (PMDA) and Ministry of Health, Labor and Welfare (MHLW). Classification dictates the regulatory procedure for the devices, so it is crucial to determine the correct classification and product code for the device before beginning its registration process.

In Japan, Medical devices are classified based on the risk to the human body. PMDA uses the following classification system for medical devices:

  • General-CLASS I (low risk)
  • Specified Controlled-CLASS II (low/medium risk)
  • Controlled-CLASS II (medium risk)
  • Highly Controlled-CLASS III (medium/high risk)
  • Highly Controlled-CLASS IV (high risk)

 Japan Medical Device Nomenclature (JMDN codes)

MHLW maintains a database of generic medical device descriptions with associated Japan Medical Device Nomenclature (JMDN) codes. This system is similar to the US FDA system of product codes or Global Medical Device Nomenclature (GMDN) system. Familiarity with the JMDN database and fluency in Japanese are essential to determine the device’s code.

If a code of a new device does not exist, the product must go through a new device pathway, and its classification is determined based on its risk according to the classification rules in Yakusyokuhatsu No. 0720022. However, the final determination of the device classification is made by the MHLW.

The registration pathway for medical devices or IVDs is determined by their classification and associated Japan Medical Device Nomenclature (JMDN) as explained here below:

Pre-market submission (Todokede)

General Medical Devices (Class I) are subject to a pre-market submission that need to be file to the PMDA. This is a notification and no review assessment by the PMDA will be conducted.

Pre-market certification (Ninsho)

Class II (and a limited number of Class III) devices which have an associated certification standard (JIS), are subject to pre-market certification. Many, but not all, Japan Industrial Standards are based on existing ISO/IEC standards. The MAH/DMAH files the application with a Registered Certification Body (RCB). The process is similar to the European CE Marking process where reviews are outsourced to authorized third parties such as Notified Bodies.

Pre-market approval (Shonin)

Class II and III medical devices without a specific certification standard, are subject to the pre-market approval process. This also applies to all Class IV devices. In this case the MAH/DMAH will file a pre-market approval application with the PMDA and ultimately obtain approval from the MHLW.

Global Regulatory Partners Japan has helped many companies register successfully their medical devices and IVDs products in Japan.

Medical writing

Medical Writing is an important function of regulatory affairs. It plays a critical role in the development and preparation of regulatory documents and defines the success or failure of new products in Japan. As Regulatory authorities (MWHL and PMDA) expect precise, clear and well-written documents, any bad writing can raise health authorities queries and consequently delay product approval. Global Regulatory Partners, Inc. (GRP), has a team of professional medical writers in Japan who can write regulatory and clinical documents in Electrical Common Technical Documents (eCTD) and CTD modules.

Health authority consultation

Consultation meetings with the MHWL and PMDA  can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team in Tokyo has the expertise in preparing consultation meeting with different heath authorities before starting key milestone of your product

 

GRP- Japan regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP-Japan regulatory affairs team has organized and supported over 100 consultation meeting with different health authorities in different markets.

Clinical

Our professionals apply their therapeutic, regulatory, and operational expertise to consistently make sure that your clinical studies are conducted with ICH guidelines and PMDA and MHWL regulatory requirements.

In an increasingly challenging environment, GRP- Japan has developed the experience and knowledge to find, recruit, and retain patients in clinical trials. We can successfully deliver access to the appropriate sites and patients, developing strategies that will minimize the risks inherent in-patient recruitment.

Global Regulatory Affairs clinical services:

  • Protocol development
  • Site and investigator identification and qualification
  • Site initiation and training
  • Clinical monitoring
  • Medical monitoring
  • DSMB coordination
  • Statistical analysis
  • Electronic data capture
  • Electronic Trial Master File
  • Full-service data management
  • gov registration and management
  • Central lab oversight and coordination
  • Site quality assurance audits
  • Integrated final Clinical Study Report

Global Regulatory Partners Japan has helped many companies conduct successfully their clinical trials for their medical devices or IVDs in Japan. 

Quality

According to the PMD Act, manufacturing facilities are subject to a Quality Management System (QMS) conformity assessment as part of the Japanese registration process. QMS conformity assessments are conducted by the Pharmaceuticals and Medical Devices Agency (PMDA) or a Registered Certification Body (RCB).

Foreign manufacturers that have chosen the Foreign Special Approval System route and hold pre-market approvals (Shonin) or certifications (Ninsho) will undergo QMS conformity assessments. Foreign manufacturers must appoint a Designated Marketing Authorization Holder (D-DMAH) to represent them in Japan.

QMS conformity assessment certification

Upon successful completion of a QMS conformity assessment, a MAH or manufacturer is issued a Certificate of QMS Conformance (Kijun Tekigoshou) by either the PMDA or RCB. Certificates of conformance are valid for five years and include the registered product name, product group (Seihingun), and manufacturing facility. Under the PMD Act, future conformity assessments focus on devices from the same product group registered with the PMDA or RCB, rather than the manufacturing facility.

Global Regulatory Partners quality team in Japan has the expertise implementing the Japanese Quality Management System in line with Ordinance 169 requirements. Our quality team can provide the following services:

  • Review your quality manual and prepare a gap analysis with references to the appropriate clauses of Ordinance #169.
  • Create and propose changes needed to comply with the Japan QMS regulation, including preparation of the Device Master File.
  • Prepare supplemental documents as an appendix of the quality manual.
  • Conduct a mock audit of your quality system prior to your PMDA conformity assessment.
  • Prepare and submit the QMS Conformity Assessment application on your behalf.

Global Regulatory Partners Japan has helped many medical devices and IVD companies implement and comply with QMS in Japan in line with Ordinance #169. 

Pharmaceuticals

Global Regulatory Partners, Inc. (GRP), provides end-to-end regulatory affairs services that allow our clients register their drug, biologic or generic products in Japan. Our regulatory services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, products’ registration and products’ life cycle management.

Through our local office in Tokyo, GRP-Japan can act as your local authorized agent in Japan and our regulatory team can support your company throughout the whole products’ lifecycle, ensuring compliance with local regulations and providing vital scientific and strategic advice from products’ development till commercialization.

Authorized local agent

Pharmaceuticals and Medical Devices Agency (PMDA) require all foreign Pharmaceutical and Biologic companies to assign a Marketing Authorization Holder (MAH) or Designated Marketing Authorization Holder (DMAH) before registering and selling their products in Japan.

 GRP Japan office is licensed by PMDA as a Category I MAH and can act as your MAH in Japan.

GRP local agent ( MAH )Services in Japan:

  • Communication with the PMDA
  • Assistance with PMDA inspections
  • Adverse Effect Reporting
  • Importation of products
  • Organize and support PMDA consultation meetings
  • Product registration
  • Product storage in an establishment with MAH licensing
  • Support importation process
  • Post-market vigilance
  • Manage Distributors

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

Global Regulatory Partners Inc. (GRP), our team of professionals can provide you with tailored Regulatory Intelligence  for Japan that includes the latest PMDA and MHWL regulatory information and recommendations for the commercialization of your Pharmaceutical or Biologic products in different markets.

Regulatory Strategy

Navigating the regulatory system in Japan is very challenging as Japan has its own set of regulations and customary manner of conducting business. Thus, determining the most effective and efficient regulatory strategy to obtain approval for your pharmaceutical product in Japan is key for your success in Japan.

Global Regulatory Partner GK Regulatory Team in Japan has many years of experience working within PMDA and within the Japanese regulatory environment and can help you define the appropriate regulatory strategy for your product in Japan. Our regulatory team will help you with the following:

GRP regulatory strategy services in Japan:

  • Identify the latest regulatory requirements related to your drug in Japan.
  • Proactively identify challenges or issues that may delay the approval of your drug in Japan.
  • Identify potential risks and obstacles so that you can avoid any unexpected roadblocks during the registration process.
  • Propose innovative solutions and approaches to circumvent these challenges ahead of time.
  • Identify the most cost-effective way to get your drug registered in Japan.

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs services to Pharmaceutical and Biologic companies globally, from their products’ development, registration,  commercialization in Japan. GRP- Japan regulatory affairs services include regulatory intelligence, regulatory strategy, regulatory operations and publishing, product’s registration, products’ life cycle management and maintenance.

Product registration

Global Regulatory Partners GK regulatory team in Japan can help you register your product in Japan by providing the following services:

  1. Prepare and Submit the registration dossier for your drug to the PMDA.
  2. Respond to PMDA queries while they are conducting the review of your application.

The submission dossier for your drug will include the following:

  • Origin or backgrounds leading up to discovery and development.
  • Product structure (physical, chemical, biological) nature
  • Stability test data
  • Toxicity data
  • Pharmacologic effects
  • Clinical data – New products must fulfill the requirements of the MFDS New Drug Application (NDA)
  • Uses in other countries (if applicable)
  • Comparison with similar domestic products (if applicable)

 ICC AND DMF REGISTRATION 

Global Regulatory Partners GK can act as your in-Country Caretaker (ICC) in Japan and provide the following services for your API:

  1. Preparation and submission of DMF for your API to PMDA.
  2. The Japanese DMF application will include the following information:
      • The name of the API, excipient or other drug substance
      • The manufacturing sites
      • The ingredients, including quantity, chemical structure, and general properties
      • Manufacturing method, process controls, process validation, process development and material controls
      • Quality control testing, analytical procedures, validation of analytical procedures, justification of specifications and excipients of human/animal origin information (if applicable)
      • Safety data
      • Non-clinical study data (primarily for new excipients)
      • Test methods, including impurities and description of methods for determining structure
      • Specifications, analytical procedures, validation of these procedures, batch analyses, justification of specifications and reference standards/materials
      • Storage method, stability testing data, post-approval stability protocol and expiration date
      • AFM or domestic manufacturing license category, number and/or date
      • ICC name and address

Regulatory Operations

Global Regulatory Partners Inc., (GRP) offers full electronic submission services from eCTD preparation, publishing and submission activities in Japan. GRP- Japan dedicated team of experts ensures the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

GRP- Japan Regulatory operation services include consulting services, planning and assembly of submissions, document creation and approval, e-Submission roadmap compliance, publishing, viewing and navigation, archiving, submission process optimization, tracking and lifecycle management.  GRP remains in compliance by implementation of Regulatory Information Management (RIM) with XEVMPD and IDMP requirements.  GRP will facilitate and coordinated management of all paper and electronic submissions, both eCTD and non-eCTD electronic submissions, and ensure timely submissions.

Health Authority Consultation

It is highly recommended to have a pre-consultation meeting with health authorities including  the PMDA and MHWL. During the development of new pharmaceutical or biologic products. Consultation meetings can serve as a valuable tool to discuss needs and challenges specific to the development of the product and design of their proposed nonclinical studies. Sponsors can also discuss their Chemistry, Manufacturing and Controls (CMC) development plan and discuss their overall development plan.

Global Regulatory Partners Inc., (GRP) regulatory affairs team has the expertise in preparing consultation meeting with the PMDA and MHLW before starting key milestone of your product development. Our regulatory affairs team supports includes: writing , preparation and submission of the meeting package to the health authority, prepare the questions to health authority based on the status of your product’s development and future plan, provide support during the meeting, write the meeting minutes and develop the appropriate action plan after the consultation meeting.  GRP-Japan regulatory affairs team has organized and supported many consultation meetings with the PMDA and MHWL health authorities in Japan’s markets.

Medical writing

Medical writing involves writing scientific documents of different types which include regulatory and research-related documents, disease or drug-related educational and promotional literature.

Global Regulatory Partners Inc, (GRP) medical writers have the expertise in presenting the collected scientific information in a suitable way so it can be understood by different target audience, namely, health authorities, patients or general public, physicians or the regulators. GRP Medical writers understand the medical concepts and terminology, knowledge of relevant guidelines as regards the structure and contents of specific documents, and good writing skills.

Clinical

In Japan, clinical trials are governed by Japanese Good Clinical Practices (J-GCP) and give local clinical site doctors much more oversight than internationally recognized standards. Japanese site heads have many responsibilities, which include signing financial contracts, ensuring site qualifications, overseeing compliance with confidentiality laws and standard operating procedures (SOPs), and determining the provisions of Investigational Medicinal Products (IMPs), among others. Furthermore, each site must have its own IRB, a provision specific to Japan.

Global Regulatory Partner GK Clinical team in Japan can help you with the following:

  • Select and work with the appropriate Institutional Review Board (IRB)

A Japanese Institutional Review Board (IRB) assesses ethical and scientific processes prior to and during clinical trials. The IRB may be established by a variety of different institutions, ranging from non-profit organizations to national universities. It is made up of at least five experts in medicine, dentistry, pharmaceutical science, healthcare, or clinical trials. The IRB members are all independent of both the medical institution supervising the trial and the founder of the IRB. The board holds meetings to review and comment on the progress of the trial. The IRB’s founder must keep records of all operating materials until receiving marketing approval and notification, or until three years after the trial is completed or terminated.

  • Select the appropriate Clinical Trial Medical Institution

In order to be considered for clinical trials, Japanese medical institutions must be well equipped, have sufficient personnel, be capable of handling emergencies, and employ competent workers for a seamless and acceptable clinical trial.

  • Work with your Investigators

A Japanese clinical trial investigator must be educated, trained, experienced, familiar with the medical device, and have sufficient time to conduct the trial. Investigators will discuss clinical trial developments to sub-investigators. Japanese investigators are responsible for choosing clinical trial participants with appropriate health conditions, symptoms, and age. All participants must willingly consent and sign an Informed Consent Form. The trial investigator then describes and explains all medical devices to the trial participants, confirms that the participants are using the device properly, and in some cases, notifies the primary physician that their patient is using the device. They must also provide adequate medical care to those suffering from adverse events. Additionally, investigators prepare, change, correct, and inspect Case Report Forms (CRFs). Finally, upon the completion or termination of the study, investigators submit a summary of the trial to the head of the medical institution.

  • Prepare the appropriate Informed Consent of Subjects

The informed consent forms must include the trial’s objective, design, and duration. Informed consent must be given before participating in a clinical trial. After giving consent, participants receive a signed and sealed copy of the form. Participants may only partake in a trial without consent if they face life-threatening emergencies in which current treatments are unlikely to help and the new device has a high probability of saving the patient’s life with minimal complications, or legal representatives are not immediately available to give consent. During the trial, a case report form (CRF) must be completed using data collected from the investigation, which will be analyzed in the clinical study report. A product approval application will then be submitted and reviewed, along with the clinical trial report.

Quality

In Japan, Good Manufacturing Practice (GMP) for drugs is referred to as Japanese GMP or J-GMP. There are other Japan-specific pharmaceutical/drug quality standards such as Good Quality Practice (GQP), Good Vigilance Practice (GVP), Good Clinical Practice (GCP), and Good Post-marketing Study Practice (GPSP).

Global Regulatory Partners GK quality team in Japan can help you to make sure that all your Japanese operations are compliant with the appropriate Japanese quality standards. Our quality team We conduct mock audits to team can help you get your manufacturing sites accredited by PMDA as well.

ACCREDITATION OF FOREIGN MANUFACTURERS (AFM) 

All foreign pharmaceutical companies that want to import their drugs into Japan must be certified by the Ministry of Health Labor and Welfare (MHLW) as an Accredited Foreign Manufacturer (AFM). All foreign AFM was that used to be referred to as Foreign Manufacturer Accreditation (FMA).

To get accredited by PMDA, an (AFM) application must be prepared and submitted for review and approval to PMDA. AFM must be prepared and submitted to PMDA for each manufacturing site.

Prepare and Submit the AFM Application

Global Regulatory Affairs GK quality team can prepare the AFM application and submit it to PMDA. GRP can assist in compiling and submitting coordinating these documents for you, however, applicants must submit the details listed below. AFM audits are generally carried out via documentary inspections, although there have been a few on-site inspections as well.

AFM Application Content:

  • Business number and its serial code (Gyosha) for each manufacturing establishment.
  • Self-Declaration of Medical Condition (Someisho) of the senior manager representing manufacturer, personal history of the responsible person of manufacturing facility to be registered, pictures, drawings, floor plans etc. showing the building(s) within the scope of registration.

Timelines:

  • It takes approximately 3 to 4 months to get AMF approved by PMDA. Once approved AFM remains valid for five years.

Global Regulatory Affairs GK quality team can prepare the AFM application and submit it to PMDA. GRP-Japan can assist in compiling and submitting coordinating these documents for you, however, applicants must submit the details listed below. AFM audits are generally carried out via documentary inspections, although there have been a few on-site inspections as well.

Cosmetics

In Japan, cosmetics are regulated by the Ministry of Health, Labor and Welfare (MHLW) under the Pharmaceutical and Medical device Law (PMDL). The law defines “Cosmetics” as “any item having mild effects on the human body that rubbed, spread, or otherwise applied in a similar manner for the purpose of cleansing, beautifying, or enhancing the attractiveness of the human body, to change the physical appearance, or to maintain skin or hair in a healthy condition.”

The PMDL, classifies cosmetics in two categories: General Cosmetics and Medicated Cosmetics (Quasi-Drugs). General cosmetics include soaps used to prevent acne and facial wash. Medicated cosmetics include hair growth and hair removal products.

Global Regulatory Partners Inc., affiliate in Japan (GRP- Japan) can help your company gain access to Japans’ lucrative cosmetic and PCP market. With offices in Tokyo our local team of regulatory professionals, GRP-Japan can develop the appropriate regulatory strategy and intelligence for the introduction of your cosmetic or PCP product in Japanese market. GRP’s team can also handle your products’ registration with PMDA (if needed), review your products labeling and formulation as per Japanese regulations and help you find the right distributor of your products in Japan.

Authorized local agent

Global Regulatory Partners. Inc (GRP). has local offices in the United States and is licensed by the NMPA. GRP- Japan can act as your local agent in Japan for your Cosmetic and Personal Care Products.

GRP-Japan Cosmetic Services:

  • Authorized local Agent
  • Regulatory intelligence
  • Regulatory Strategy
  • Regulatory affairs
  • Product Registration
  • Cosmetic packaging and labeling review
  • Product classification & Formulation Review

Regulatory intelligence

Global Regulatory Partners Inc. (GRP) experts can collect the regulatory and other important requirements applicable to your product such as: registration dossier, claims, prohibited list of ingredients, importation regulations, specification of ingredients and labeling requirements that are needed to establish the correct strategy for your product commercialization in Japan’s Market.

Regulatory Strategy

Developing the right regulatory strategy for your products for different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of products and for different markets. Our tailored regulatory strategy will help you meet your business objectives and goals and reduce your risk of failure in Japan. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals and timelines, PMDA regulatory requirements related to your product, cost, and risk assessment. With a global presence and a local team of experts in Tokyo, Our tailored regulatory strategy will include  a list of the necessary documentation needed for product development and registration, timelines and cost of the different activities, and action plan to meet your milestones will give you confidence in the forecast of key milestones

Regulatory Affairs

Global regulatory Partner Inc. (GRP), provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Japan include regulatory intelligence, regulatory strategy, regulatory operations, and publishing; product registration, registration amendments; consulting meetings with regulatory authorities. Our Regulatory affairs teams help medical device companies understand and efficiently manage the demanding complexity of the diverse Regulatory requirements in order to successfully register and commercialize their products in new markets and maximize the value of their assets.

Cosmetic packaging and labeling review

Global regulatory Partners, Inc. (GRP) , provides end-to-end cosmetics packaging and labeling services to enable manufacturers effectively navigate PMDA and MHWL  regulations, manufacture and sale compliant products. GRP’s services include cosmetic packaging and labeling review to ensure that their content is in compliant with local and /or regional requirements and the products can be used safely by consumers. GRP Inc. can review your products and make sure they comply with the Japan’s Pharmaceutical and Medical device Law (PMDL).

Product classification & Formulation Review

Global Regulatory Partners Inc. (GRP), provides a comprehensive range of Regulatory Services related to the analysis of the list of cosmetic and PCP ingredients, the review of their formulation and labeling. GRP Inc. can review your products and make sure they comply with the Japan’s Pharmaceutical and Medical device Law (PMDL).

Nutraceuticals

In Japan, Nutraceuticals or food supplements, known as “health foods”, include two categories; Foods with Nutrients Function claims and Foods with Specified Health Uses. Foods with nutrients function claims can be used freely as far as their content satisfies the minimum and maximum daily levels of consumptions. Specified Health Uses contain dietary ingredients that have beneficial effects on physiological functions of the human body. However specified health use supplements are not allowed to make “disease reduction” claims. Health foods are regulated by several acts including the Health Promotion Act, Food Sanitation Act and Pharmaceutical Affairs Act.

In Japan the general process for application of “Health Foods” is as follows: The Food Safety commission examines the safety of the product, the Pharmaceuticals affairs and food sanitation council evaluates the effectiveness, then the Ministry of health, Labor and Welfare gives the official approval. Once this approval is obtained the manufacturer is allowed label the claims and mark on the product.

Global Regulatory Partners, Inc. (GRP), has a team of experts in Japan who can help Nutraceutical and food supplements companies in Japan during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

Authorized local agent

Global Regulatory Partners, Inc. (GRP), has a team of experts in Japan who can help Nutraceutical and food supplements companies in Japan during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by PMDA regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.

GRP -Japan Nutraceutical Services:

  • Authorized local agent
  • Regulatory intelligence
  • Regulatory strategy
  • Regulatory affairs
  • Product Registration
  • Verification of Nutrient Content Claims
  • Verification of Health Claims

Regulatory Affairs

Global regulatory Partner, Inc., (GRP) provides a full regulatory affairs service from product concept throughout product development till product registration. Our regulatory affairs services in Japan include regulatory intelligence, regulatory strategy, product registration, product formulation and labelling review.

GRP- Japan provides support to Nutraceutical companies during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers, reviews and validates the nutrient content claims and health claims before products’ commercialization.

Regulatory intelligence

Regulatory intelligence (RI) is an essential tool for regulatory professionals. RI allows professionals to develop the most appropriate regulatory strategy for a successful, efficient, and cost- effective product development, registration, and commercialization.

At Global Regulatory Partners Inc. (GRP), our team of local professionals in Japan can provide you with tailored Regulatory Intelligence that includes the latest PMDA and MHWL regulatory information and recommendations for the commercialization of your Nutraceuticals in Japan’s markets.

Regulatory Strategy

Developing the right regulatory strategy for your Nutraceuticals in different markets is crucial for successful product development, registration, and commercialization. Global Regulatory Partners, Inc., (GRP) team has expertise in developing the appropriate and effective regulatory strategy for different types of Nutraceuticals for different markets. GRP-Japan tailored strategy will help you meet your business objectives and goals and reduce your risk of failure in Japan. In developing the regulatory strategy, our team takes into consideration different factors such as information on your products and similar products on the market, your product development status and milestones, your business goals, your timelines, the regulatory requirements related to your product, cost, and risks. With a global presence and our local team of experts, GRP regulatory strategy will help forecast your Nutraceutical launch and commercialization with confidence in Japan.

Verification of Nutrient Content Claims

Nutritional claims are those that state, suggest or imply that a food has some particular- beneficial nutritional properties. This information helps consumers to take an informed decision about whether to purchase and consume the product or not. Nutritional labels and packaging should include information on energy, calories, fats, sugars, proteins and salts. It is important that all this information is accurate and correct, as all nutritional details must comply with the Regulations.

In addition, the PMDA and MHWL regulations have certain rules governing the provision of voluntary nutrition information, particularly for the front of pack labeling, the nutritional labeling of non-pre-packaged foods and the energy labeling of alcoholic drinks. Some nutrients are now prohibited to be declared. A nutrient content claim expressly or by implication characterizes the level of a nutrient in a dietary supplement.

GRP- Japan can review your products and make sure they comply with Japan’s health foods regulated under several acts, including the Health Promotion Act, Food Sanitation Act and Pharmaceutical Affairs Act.

Verification of Health Claims

Health claims are directed to the general population or designated subgroups (e.g., the elderly) and are intended to assist the consumer in maintaining healthful dietary practices. GRP’s team in Tokyo has the expertise in reviewing and validating the health claims that you are making for you nutraceutical products or dietary supplements to make sure that they are supported by scientific data, are accurate and can be accepted by PMDA standards. GRP- Japan can review your products and make sure they comply with Japan’s health foods regulated under several acts, including the Health Promotion Act, Food Sanitation Act and Pharmaceutical Affairs Act.

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