Greetings from Freyr Japan
With exceptional knowledge of pharmaceutical Regulatory Affairs in Japan, Freyr assists foreign manufacturers with medicinal products Regulatory support in Japan. To expedite your drug’s Japan market entry, Freyr Japan offers comprehensive Regulatory services right from Regulatory intelligence to dossier preparation and submissions for drug approvals.
In order to develop drugs and medical devices in Japan, it is necessary to be familiar with the role of Pharmaceuticals and Medical Devices Agency (PMDA).
PMDA is the leading Health Authority (HA) in Japan. The PMDA works along with the Ministry of Health, Labour, and Welfare (MHLW) and is responsible for monitoring the registration and sale of medicinal products and medical devices in the country. The Agency aims at ensuring the safety, efficacy, and quality of the products that are being marketed in Japan. PMDA regulates drugs, medical devices and cosmetic products under the Pharmaceuticals and Medical Devices Act (PMD Act), and it also regulates health foods under the Food Sanitation Law.
Freyr Japan also has rich knowledge of the role of PMDA. Freyr Japan has extensive knowledge of the role of PMDA.
Industries We Serve
As a part of the global multicentre development programs, global pharmaceutical companies are showing increasing interest in the Japanese pharmaceutical market. The growing number of foreign pharmaceutical companies entering the Japanese market will lead to an increase in the number of approvals of drugs developed by foreign companies in Japan. To enter the Japanese pharmaceutical market, foreign drug developers need to be aware of the strict and rigorous registration and Regulatory pathways established by the Ministry of Health Labour and Welfare (MHLW),
Click here to find out how to register your medicinal product in Japan.
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Japan is the second biggest market for Medical devices and is expected to reach US $74.4 billion by 2025. Key factors driving growth for medical device registration in Japan are:
- Population increasingly skewed toward geriatrics
- Increase in life-style diseases and chronic health conditions
- A wider population base being covered under universal health insurance
- Regulatory changes to facilitate innovative technologies
Click here to find out how to register your device in Japan.
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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 imported foods, the MHLW monitors and inspects them at the quarantine stations located at the international airports and seaports.
Click here to find out how to register your food product in 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 the Pharmaceutical Affairs Law. The MHLW focuses on reviewing the applications of quasi-drugs and cosmetic registrations in Japan (both from foreign manufacturers and importers) and evaluates their adverse effect reports.
Click here to find out how to successfully register your cosmetic product in Japan.
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About Freyr
Freyr is one of the largest global, Regulatory-focused solutions and services companies for the Life Sciences industry supporting Large, Medium, and Small-sized global life sciences companies, (Pharmaceutical | Generics | Medical Devices | 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.
Know MoreOur Regional Expertise
Being a Globally Local firm, we have our presence in the following countries, click to know more
