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Overview
Traditional medicines-including Traditional Chinese Medicines (TCM), Traditional Herbal Medicines (THM), and Ayurvedic Medicines and Traditional Herbal Medicinal Products (THMP)-have been integral to healthcare systems for centuries. Sourced from culturally rich regions with ancient practices, these products are increasingly entering global markets driven by consumer demand for natural and holistic wellness solutions.
Though this sector has shown great progress in developing these medicines, its Regulatory framework is constantly becoming more complicated due to the emerging global markets demanding higher standards of quality, safety, and efficacy.
With Freyr Solutions, we offer you unparalleled regulatory support to ensure smooth market entry for manufacturers and distributors of traditional medicines while aiding them in adhering to regional regulations.
Our Expertise Across Global Markets
Freyr provides Regulatory services aligned with various traditional medicine standards, including:
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Traditional Chinese Medicines (TCM)
Regulatory Support is provided for the registration of proprietary chinese medicines in accordance with NMPA requirements, including dossier preparation, safety evaluation, and GMP compliance.
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Traditional Herbal Medicines (THM)
Registration is facilitated under the EU Directive 2004/24/EC (THMPD), Covering technical dossier preparation, quality and safety requirements, and traditional use evidence. Support for global herbal product registration is also available.
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Ayurvedic Medicines
Regulatory assistance is offered for compliance with Ministry of AYUSH (India) guidelines, including ingredient review, product labeling, manufacturing licensing, and registration under the Drugs and Cosmetics Act, 1940.
Traditional Medicines Regulatory Compliance by Country: Key Regulations Across Top Regions
Freyr Comprehensive Regulatory Services
Freyr's end-to-end Regulatory services for Traditional medicine compliance include:
Why Choose Freyr?
End-to-end Regulatory consultation for Traditional Medicines Regulatory registration
A qualified team of experts with hands-on experience across all categories of Traditional Medicines
Support in region-specific Regulatory activities
Proven track record in securing traditional medicine product approvals
An extensive partnership network across the globe
A structured and cost-effective approach to ensure speed to market for the products
