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Freyr Expertise

  • End-to-End Pharmaceutical Product Registration 
  • Authorized Local Agent Support
  • GMP Support
  • Dossier Gap Analysis as per the PMDA Regulations
  • Preparation of Gap Analysis Report and Remediation Plan
  • Pharmaceutical Dossier Preparation and Submission to the PMDA
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Greetings from Freyr Japan

Pharmaceuticals and Medical Devices Agency (PMDA) is the leading Health Authority in Japan. PMDA works along with the Ministry of Health, Labour and Welfare (MHLW). PMDA is responsible for monitoring the registration and sale of Pharmaceutical Products and Medical Devices in the country. The Agency aims at ensuring the safety, efficacy and quality of the products circulating in Japan. The MHLW regulates cosmetic products under the Pharmaceutical and Medical Devices Law (PMDL), and it also regulates health foods under the Food Sanitation Law.

 

Industries We Serve

As part of the international multicentre development programs, global pharmaceutical companies are turning towards Japan for conducting clinical trials. This hints towards an upcoming surge in drug development in Japan and also an increase in the number of pharmaceutical product registrations. To be a part of Japan’s pharmaceutical market, however, foreign drug developers need to be aware of the stringent registration and Regulatory pathways laid out by the Pharmaceuticals and Medical Devices Agency (PMDA).

  • End-to-end Pharmaceutical Product Registration
  • Authorized Local Agent Support
  • GMP Support
  • Dossier Gap Analysis as per the PMDA Regulatory Requirements
  • Preparation of Gap Analysis Report and Remediation Plan
  • Pharmaceutical Dossier/DMF Preparation and Submission to the PMDA
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Japan is the second biggest market for Medical Devices and is expected to reach US $74.4 billion by 2025.

The key factors driving growth in the Japanese Medical Device market are:

  • Population increasingly skewed toward geriatrics
  • Increase in lifestyle diseases and chronic health conditions
  • A broader population base being covered under the universal health insurance
  • Regulatory changes to facilitate innovative technologies
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In Japan, health foods are regulated by the Ministry of Health, Labour and Welfare  (MHLW) under the Food Sanitation Law. Japan is a major food importer, with a food self-sufficiency rate of about 40%. Therefore, Foods are imported from various countries. To ensure the safety of the import foods, the MHLW monitors and inspects them at the quarantine stations located at the international airports and seaports.

  • End-to-end Food and Food Supplements Regulatory Consultation for Japan
  • Food Product Classification Guidance for any Complexities for Health Foods
  • Support for Region-specific Regulatory Activities
  • Strong Relationship with Various Health Authorities (MHLW for Japan)
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In Japan, cosmetic products are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical and Medical Devices Law (PMDL), formerly known as Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi-drugs and cosmetic registrations in Japan (foreign manufacturer, importer), and evaluates their adverse effect reports.

  • Product Classification
  • Product Testing
  • Ingredient Analysis (as per the Japan Cosmetic Industry Association (JCIA) Standards)
  • Label Compliance Claims Review
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About Freyr

Freyr is a leading, niche, full-service global Regulatory Solutions and Services Company supporting, Large, Medium and Small size global Life sciences companies, (Pharmaceutical | Generics | Medical Device | Biotechnology | Biosimilar | Consumer Healthcare | Cosmetics | Chemicals) in their entire Regulatory value-chain; ranging from Regulatory Strategy, Intelligence, Dossiers, Submissions etc. to Post- Approval / Legacy Product Maintenance, Labeling, Artwork Change Management and other related functions.

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Our Regional Expertise

Being a Globally Local firm, we have our presence in the following countries, click to know more

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