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What is Kampo Medicine?

Kampo Medicine, rooted in Traditional Chinese Medicine, has evolved over centuries to become an integral part of Japan's healthcare system. Recognized for its holistic approach, Kampo emphasizes restoring balance in the body using plant-based herbal formulations. Unlike Western medicine, which often targets specific symptoms, Kampo addresses the root causes of health issues, making it a preferred complementary therapy.

The Growing Relevance of Kampo Medicine in Japan

With increasing government support and public acceptance, Kampo is witnessing a resurgence in modern healthcare. The Pharmaceuticals and Medical Devices Agency (PMDA) has implemented rigorous regulations to ensure the quality, safety, and efficacy of Kampo products. Moreover, the integration of AI-powered research and advanced analytics has accelerated the discovery of new applications for traditional formulations.

Pharmaceutical companies in Japan are increasingly investing in Kampo-based drug development, leveraging AI to optimize formulations and predict therapeutic outcomes. This modernization is paving the way for Kampo medicine to expand its footprint in global markets.

Navigating Regulatory Complexities with Freyr Solutions

For companies exploring the Kampo medicine market, compliance with Japan's regulatory framework is essential. Freyr Solutions, with its comprehensive end-to-end regulatory services, offers unparalleled support in achieving PMDA approvals. Our expertise includes regulatory strategy development, submission management, and post-market compliance, ensuring seamless market entry.

Whether you are a traditional medicine manufacturer or a pharmaceutical innovator, Freyr Solutions ensures your Kampo products meet Japanese regulatory standards while maintaining their therapeutic integrity.

Partner with Freyr Solutions to bring your Kampo innovations to the Japanese market.

Contact us today to explore tailored regulatory solutions.

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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What is Kampo Medicine?

What is Kampo Medicine?

The Growing Relevance of Kampo Medicine in Japan

Navigating Regulatory Complexities with Freyr Solutions

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