Japan’s PMDA

Medical Devices

Pharmaceutical and Medical Device Act

Medical devices are regulated by the Act on Securing Quality, Efficacy and Safety of Pharmaceuticals, Medical Devices, Regenerative and Cellular Therapy Products, Gene Therapy Products, and Cosmetics (hereinafter referred to as “the Pharmaceuticals and Medical Devices Act) , which came into effect in November 2014.

GRP Regulatory Services in Japan:

Global Regulatory Partners Inc. GRP, is an MAH holder in Japan and has a team 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.

Market Authorization in Japan:

In Japan, a person who intends to market specially controlled medical devices, controlled medical devices or in vitro diagnostics  is to be certified for each product by certification bodies registered by the Minister of Health, Labour and Welfare based on Ministerial Ordinance.”

Foreign Manufacturers:

Foreign Manufacturers must designate a marketing authorization holder to market Medical Devices.

Authorized local agent

An MAH conducts safety management on behalf of the foreign company. In addition, to safety management, a designated MAH should also perform various procedures such as submission of the drug application,  post-market surveillance (PMS), etc.

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. 

Japan’s system restrict market access to foreign company who do not have their own corporation in Japan.  It is necessary for a foreign company to assign a Japanese MAH  (Designated Marketing Authorization Holder) who has the appropriate  licenses.

Approval is granted under the condition that a foreign company has a designated MAH

GRP GK ( GRP-Japan) is licensed by PMDA to act as your MAH in Japan. GRP is a MAH license included both IVD and MD licenses.

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 & Market Access

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

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.

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. 

All of the regulatory strategy is paramount for when having meeting with PMDA. As the PMDA will ask all these questions about your product.

Being prepared reduces timelines.

GRP 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.

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.

Product registration

After Assigning your MAH/DMAH and 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.

The registration pathway for medical devices or IVDs is determined by their classification and associated Japan Medical Device Nomenclature

The MWHL defines Medical Devices as :

“medical appliances or instruments (excluding regenerative medicine products) intended for use in the diagnosis, treatment or prevention of disease in humans or animals, or intended to affect the structure and functions of the bodies of humans or animals…”

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.

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.

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.

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.

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

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. GRP-Japan regulatory affairs team has organized and supported  numerous PMDA consultation meeting  for medical device products.

Global Regulatory Partners Inc., (GRP) regulatory affairs team in Tokyo has the expertise in preparing consultation meeting with PMDA 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. 

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

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 who 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.

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.

  • 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. 

More Resources:

Pharmaceuticals

GRP Pharmaceutical Services:

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. Japan’s system restrict market access to foreign company who do not have their own corporation in Japan.  It is necessary for a foreign company to assign a Japanese MAH  (Designated Marketing Authorization Holder) who has the appropriate  licenses.

An MAH conducts safety management on behalf of the foreign company. In addition, to safety management, a designated MAH should also perform various procedures such as submission of the drug application,  post-market surveillance (PMS), etc.

GRP-Japan is licensed by PMDA as a Category I MAH and can act as your MAH 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 & Market Access Services

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.

  • Regulatory Intelligence (RI),
  • Regulatory Strategy,
  • Regulatory operations and publishing,
  • Product’s registration,
  • Products’ life cycle management and maintenance.

Japan is the third-largest drug market in the world.  In 2019, the pharmaceutical market size in Japan was worth $95 billion. The growth of the Japanese generics drug market is the most interesting, in less than a decade ,  its market worth doubled and was valued at approximately $ 1.66 trillion Japanese yen, in 2018. Currently, the Generics market  represent 80% of the pharmaceutical market and  have been continuously growing since the government started to promote their use in 2007.

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 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 

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:

  • 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.

 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. GRP- Japan ( GRP-GK) has a dedicated team of experts that ensure the quality and validity of the dossier submissions in accordance to the technicalities of regional eCTD requirements.

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.

Product registration

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 (FMA). All foreign AFM was that used to be referred to as Foreign Manufacturer Accreditation (FMA).

FMA number is necessary component for Product Dossier Submission.

Preparation and Submission of the FMA Application:

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.

  • 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 5 months to get FMA approved by PMDA. Once approved FMA remains valid for five years.

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.

GRP’s regulatory affairs team support services:

  • 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
  • Act as your Market Authorization Holder (MAH)
  • Determine classification of your pharmaceutical product
  • Help you determine the proper regulatory pathway for your product
  • 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
  • Preparation and submission of DMF for your API to PMDA.
  • Assistance to comply the correct DMF material for application.

GRP White Paper: Registration of DMF in Japan

In Japan, Drug Mater File (DMF), is a system that was introduced by PMDA to allow Japanese and foreign manufacturers (MF Holders) of drug substances, intermediates, excipients, raw materials, and packaging materials to voluntarily register confidential information related to the manufacturing and control of their products

GRP White Paper: Consulation Meetings with the PMDA

Pharmaceuticals and Medical Devices Agency (PMDA), the Japanese Regulatory Authorities, offers pharmaceutical and biotech companies, different types of consultation meetings, to allow them seek guidance and advice during their clinical development programs till product registration in Japan.

GRP White Paper: Foreign manufacturers Accrediation (FMA)

All foreign manufacturers intending to manufacture drugs, quasi-drugs, medical devices, or drug substances in foreign countries and export them to Japan, are required to be accredited by the Minister of Health, Labor, and Welfare (MHLW) as an “Accredited Foreign Manufacturer”.

GRP White Paper: Orphan Drug Designation in Japan

MHLW makes orphan designation decisions on a case-by-case basis. The decision is based on the opinion of the Pharmaceutical Affairs and Food Sanitation Council (PAFSC), who reviews the scientific report prepared by the Pharmaceuticals and Medical Devices Agency (PMDA).

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.

Request of Clinical Trial in Japan:

In Japan, when a clinical study is requested, a contract for clinical trials can be concluded only when 30 days have passed from the initial notification of the study protocol received by the PMDA (at least 2 weeks have passed for subsequent notifications, as a rule).

1) Drugs with new active ingredients
2) Drugs with new administration routes(excluding bioequivalence studies)
3) New combination drugs, drugs with new indications or new dosage and administration (excluding bioequivalence studies)
4) Drugs containing the same active ingredients with the drugs with new active ingredients, for which the reexamination period has not been completed yet (excluding bioequivalence studies)
5) Drugs considered to be biological products [excluding 1) to 4)](excluding bioequivalence studies)
6) Drugs manufactured using gene recombinant technology [excluding 1) to 5)] (excluding bioequivalence studies)

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). Generally, GMP compliance inspection shall be onsite inspection by the PMDA however, in some cases inspection may be conducted on documents basis depending on the judgment of the PMDA for example, based on the product’s risk, the country’s GMP standards and their operation, and documents submitted for the inspection.  

All manufacturing sites (including external testing laboratories) listed in the marketing approval application or authorization are subject to GMP compliance inspection.

1) Inspections that are conducted at the point of application for new marketing approval or of application for partial changes of approved information

2) inspections that are conducted every five years following the obtainment of marketing approval.

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.

More Resources:

  • “Read More” to access more information on Pharmaceuticals in Japan
  • GRP Presentation. Drug Master File (DFM) Registration in Japan
  • GRP Presentation. GRP company capabilities in Japan.
Japan

Cosmetics

In Japan, cosmetics are regulated by the Ministry of Health, Labor and Welfare (MHLW) under the Pharmaceutical and Medical device Law (PMDL).

GRP Services:

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.

Cosmetic Definition

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.”

Japan Cosmetic Categories:

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.

Authorized local agent

Global Regulatory Partners. Inc (GRP). has local offices in Japan and is licensed by the PMDA. 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

Cosmetic Market Overview:

Japan is one of the largest markets for cosmetic and personal care products in the world.The domestic beauty industry known as J-Beauty,  generated a revenue of over 36 billion U.S. dollars in 2017. Within the Japanese cosmetics market, skin care products are dominating, accounting for a market share of almost 50 percent.

Japanese Consumers:

Japanese consumers are renown in being sophisticated and well informed regarding the chemical formulations in hair products. Japanese consumers have the highest per capita expenditure on cosmetics including skin care products which in turn is boosting the growth of beauty and personal care market in the country.

Trends:

Multi-Use and Fast-acting skincare products:

Popular items for Japanese consumers are high-performance products, quick-acting skincare products, and crossover products with multi-appeal attributes. 

Natural ingredients and organic formulations

Consumers high demand in this market has driven manufacturers to launch products with natural/clean product labels.

PMDA Regulation: Cosmetic Standard

The Cosmetics Standards classify which ingredients may be used for cosmetics only by the amount approved in this standard as well as a list of prohibited ingredients. For sale in English.

PMDA Regulation: “List of Active Ingredients in so-called medicinal Cosmetics”

The guide lists the maximum amount allowed for each ingredient in “medicinal-cosmetics”.

product registration ( cosmetics & quasi-drugs)

claims & classification

Based on the claims and the purpose of the product the regulations will classificy with into two different categories, cosmetics or quasi-drugs. 

Definition of Cosmetics (化粧品):

Cosmetics are defined as “articles with mild action on the human body, which are intended to be applied to the human body through rubbing, sprinkling or other method, aiming to clean, beautify and increase the attractiveness, alter the appearance or to keep the skin or hair in good condition.”

Cosmetics are further divided into 6 categories :

  1. Perfume and eu de colgne
  2. Makeup
  3. Skin Care
  4. Hair Care
  5. Special-Purpose 
  6. Soaps

Definition of Quasi-Drugs( 医薬部外品) :

A “Quasi-drug” as an item for the purpose of:

(1) Preventing nausea and other discomfort

(2) Preventing heat rash, soreness, etc.

(3) Encouraging hair growth or removing hair, or

(4) Exterminating and preventing mice, flies, mosquitoes, fleas, etc.

Among the quasi-drugs are deodorants, depilatories, hair growth treatments, hair dyes, perm and straightening products, as well as medicated cosmetics, such as whitening products, anti-aging products and oily skin or acne treatment products.

GRP whitepaper: Registration of cosmetics & quasi-drugs in japan

In Japan, cosmetics are regulated under Pharmaceutical and Medical Devices Law (PMDL, formerly Pharmaceutical Affairs Law) and they are classified into two categories: cosmetics and quasi drugs. The regulations governing each category differ greatly.

Cosmetic packaging and labeling review

Japan cosmetic Labeling Requirements:

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. Label names should be translated into Japanese from the International Nomenclature of Cosmetic Ingredients (INCI) names published by the Cosmetic, Toiletry, and Fragrance Association (CTFA) of the United States. Labels in Japan  requires that the container, packaging, or package inserts of cosmetics to be labeled with a list of specified items, depending on the type of products and container.

For cosmetics:

  •  Product name by type
  • Brand name
  • Name and address of primary distributor
  • Content (weight or capacity)
  • Country of origin
  • Manufacturing number or code
  • List of ingredients as required by the MHLW
  • Expiration date, for a cosmetic designated by the MHLW
  • Precautions on usage or storage
  •  Contact Information

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).

Health Foods & Supplements

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.

GRP Services:

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.

Health Food Application Pathway:

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.

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

Market overview:

In Japan, the health food and dietary supplement industry is thriving  due to the consumption power of its large aging population and their health and beauty conscious youth. The health food and dietary supplements have become a staple for the lifestyle of the Japanese who are deeply mindful of their health, beauty, and body.

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.

GRP’s Nutraceutical Regulatory Strategy Services:

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.

GRP Nutraceutical Regulatory Services:

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.