OC-71: MAIN REGULATORY CRITERIA FOR THE CLINICAL DEVELOPMENT OF NATURAL PRODUCTS

J Pharm Pharmacogn Res 3(suppl. 1): S83, 2015

Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015  September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.

Oral Communication

OC-71: MAIN REGULATORY CRITERIA FOR THE CLINICAL DEVELOPMENT OF NATURAL PRODUCTS

Rodríguez J.

National Center Coordinating of Clinical Trials (CENCEC), Ave. 5ta A between/ 60 and 62 St., Miramar, Havana, Cuba. E-mail: julian@cencec.sld.cu, Telephone: 7204 – 73-45.

 

Introduction: The use of the natural medicine for the treatment of the different illnesses has increased their use and importance in the international trade. In spite of this situation, the data of security and effectiveness of a number of plants, their extracts, their active principles and the finished products are poor. The requirements of security and effectiveness that should complete these products for being marketed under their medical use are settled down by Regulatory Agencies of Medicines (RMA). Objective: To show an overview of main regulatory criteria for the clinical development of natural products. Methods: An exhaustive bibliographical search was carried out using as key words: Regulation – Products – Natural. The primary sources of information were, Web of the FDA, EMEA and IBERO-AMERICAN COUNTRIES, Web of the World Organization of the Health (WHO) and Databases (MEDLINE, CENTRAL BIOMED and HINARI). Results: The analysis of the information showed that the focus of the RMA regarding the clinical development of these products differs of a country to other. Most of the underdeveloped countries have a great quantity of phytomedicines based on popular knowledge and with big lacks of legislative approaches to establish these products of traditional use as medications. Conclusions: Europe takes the leadership in the development of regulatory framework for the clinical development of the natural products. The United States in June 2004 opened the way of natural products as drugs with the release of the document “Botanical Drug Products”, establishing the first guideline for the registration of this product type as a drug. With some exceptions most of the regulations in existence is directed to the control of herbal products and it does not take into account all the products conceived inside the natural medicine.  These products in Cuba are regulated by the regulation 28-13.

 

Citation Format: Rodríguez J (2015) Main regulatory criteria for the clinical development of natural products. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S83. Abstract nr OC-71.