Regulatory status of herbal medicines-Considerations about Cuba and Latin America

6^th International Conference and Exhibtion on Pharmaceutical Regulatory Affairs and IPR

September 29-30, 2016 Orlando, USA

Diadelis Remirez Figueredo

National Centre of the State Quality Control of Drugs & Medical Devices, Cuba

Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

In the last decade there has been a global upsurge in the use of traditional medicine and complementary and alternative medicine in both developed and developing countries. This is one of the main reasons for reinforcing the surveillance of the safety, efficacy and quality control of traditional medicine, complementary and alternative medicines. This work describes important aspects about the art state of the regulatory status of herbal medicines. Besides that, data related with the countries involved in the World Health Organization (WHO) program for traditional medicine will be showed. Another important aspect is, the importance of clinical trials in order to guarantee the safety, quality and efficacy of Natural Health Product, the main mistakes in clinical trials of natural products are explained. The market and the main challenges are analyzed in the investigation of the phyto-medicines as well as the tendencies in the growth of this attractive sector. The WHO strategy for the development of herbal medicinal product is also showed. The regulatory framework of traditional medicine in Cuba and in Latin America will be presented as well as the implementation of WHO strategy. In conclusion, Drug Regulatory Authorities should ensure the quality, safety and efficacy of traditional medicines.

Biography :

Email: diade.remirez@infomed.sld.cu