Phyto-Network-Munich

For example, the changes in the legal framework and business environment for the herbal medicinal products market led to more exacting standards for procurement, processing, registration and scientific documentation. However, these changes also open new market opportunities:

• The new Directives of the European Union on "traditional" herbal medicinal products (2004/24/EC) and "well established medicinal use" (2001/83/EC) have facilitated (bibliographic) registration procedures for herbal medicinal products and will increase the importance of these product classes in the near future.
  
  
• The mandatory CTD format for expert reports as well as the obligation to regularly provide PSURs constitute new qualitative and quantitative challenges for the departments of regulatory affairs and medical science.
  
  
• Clinical trials, observational studies as well as pharmacological and toxicological investigations require a substantial planning and documentation effort. Up-to-date knowledge of the regulatory guidelines and the market environment for herbal medicinal products are essential for the application of the data obtained in these studies for various purposes such as national and international registration procedures, pharmacovigilance and marketing.
  
  

• Demands on quality of botanicals are becoming more complex. Registration authorities increasingly require production according to the GA(C)P-Standard and a complete traceability of the raw material. Ethical sourcing of herbal raw material (e.g., sustainability) gains increasing importance for the consumer and therefore provides chances for differentiation in the market.

Our network offers the scientific expertise required by your departments of regulatory affairs, medical science and sourcing. Please consult the appendix for an overview of the services we offer. Should you have any queries or are interested in our services please do not hesitate to contact us.

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