HMPC - SAWP, Valletta - Main contents
| date | April 27, 2017 - April 28, 2017 |
|---|---|
| city | Valletta, Malta |
| location | Dolmen Resort Hotel  |
| organisation | Maltese presidency of the EU (Maltese presidency) i |
The Committee on Herbal Medicinal Products (HMPC) meets at the European Medicines Agency (EMA) in which all experts of the National Competent Authorities (NCAs) participate. The HMPC was established in 2004 in accordance with Regulation (EC) No 726/2004 and Directive 2004/24/EC, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States. The main task of the Committee is to establish EU Herbal Monographs for the main herbal substances on the EU market. Also, the Committee can draft so-called List Entries, which are established by the European Commission. The HMPC’s activities aim at facilitating the harmonisation of procedures and provisions concerning herbal medicinal products laid down in EU Member States, and further integrating herbal medicinal products in the European regulatory framework.
The committee has one member and one alternate member nominated by each of the 28 EU Member States and by Iceland and Norway. They are experts from the Member States in the field of herbal medicines. Additionally, five co-opted members are nominated by the Member States with specific expertise.
The Scientific Advice Working Party (SAWP) is a standing working party with the sole remit of coordinating the provision of scientific advice and protocol assistance. It was established by the Committee for Medicinal Products for Human Use (CHMP). The SAWP formulates scientific opinions based on their expertise for the CHMP and the COMP. Scientific advice can relate to: quality relating to the development of medicinal products; non-clinical and clinical safety and efficacy relating to the development of medicinal products and the significant benefit of orphan medicinal products.
The SAWP is a multidisciplinary group, which comprises a chairperson, 28 members including three members of the Committee for Orphan Medicinal Products (COMP), one member of the Paediatric Committee (PDCO) and one member of the Committee for Advanced Therapies (CAT) to ensure the link to these committees.