Herbal Medicinal Products: Development and Registration
Express lane to success
In China, traditional herbal medicines (Traditional Chinese Medicines, TCMs) have been used therapeutically for thousands of years. A simplified procedure for registration of traditional herbal medicinal products (THMP) and herbal products with a well-established use (WEU) was implemented in the European Union (EU) in 2004. As a consequence, an increasing number of TCMs (e.g., Ginseng) have gained access to the EU market. However, in spite of the simplification, the EU registration procedure for herbal medicinal products still requires significant regulatory expertise. Therefore, entry into western markets remains an issue for many pharmaceutical companies involved in the development of herbal medicinal products.
Kinesis Pharma supports these companies by offering a superior range of services tailored towards successful registration of herbal medicinal products in the EU.
Cultural bridge in Kinesis Pharma
Kinesis understands that herbal medicines have a long tradition based in culture and history. With this in mind Kinesis’ international team of experts will provide companies the best possible support to register their products in Europe. The global network, international experiences, competent and multi-disciplinary groups make Kinesis the most suitable partner in the field of herbal products registration in Europe.
Consultancy and preparation of documents
Non-clinical overviews
A significant amount of non-clinical pharmacological, pharmacokinetic and toxicological information on herbal medicinal products is publically available. For registration purposes, this information should be summarized and presented in an integrated format, in order to meet the requirements of the EU regulatory authorities. Kinesis has acquired extensive experience in the preparation of these comprehensive regulatory documents with an emphasis on the unique attributes of certain herbal products. In addition, Kinesis advises and supports herbal medicinal companies on critical issues and the use of technical (scientific) data in accordance with EU regulations.
Clinical overviews and regulatory dossiers
An overview of the available clinical pharmacology, safety and efficacy data for herbal medicinal products is one of the essential parts of the documentation necessary for registration. Kinesis can prepare these clinical overviews and/or can provide an in-depth analysis of the requirements for each section of Module 2.5 in Common Technical Document (CTD) format. The experienced team of clinical consultants within Kinesis tailors the document according to the product characteristics and regulatory requirements, with an emphasis on the benefits and risks.
Additional regulatory documentation
Kinesis can prepare all necessary regulatory documentation, such as safety expert reports, summaries of product characteristics (SPCs), patient information leaflets in CTD format etc. Translation and management of applications and post-approval activities are important parts of Kinesis’ core businesses. An experienced team of senior consultants in all relevant disciplines can offer a complete package of services to meet the needs and expectations of clients, and to ensure rapid and effective submission of the registration dossier.
Chemistry, Manufacturing and Control (CMC) dossiers
The quality aspect of the herbal medicinal product is independent of its traditional use. Therefore, product-related information with respect to specification, manufacturing and reproducibility and microbiological characteristics needs to be provided. Kinesis has an experienced team of CMC consultants who are able to support and guide herbal medicinal companies to focus on the key points, such as quality control for herbal substances, intermediates and finished products, development and specification of manufacturing procedures, control of critical steps, validation of manufacturing and analysis methods, product stability and reproducibility. CMC is central and crucial for the registration and marketing of herbal products, and therefore a high quality CMC dossier is an essential prerequisite for successful registration.
"Herbal medicine is a gift from nature"
Contact detailsPengyue Sun, Ph.D. |
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