Scientific Committee on Medicinal Products and Medical Devices

Opinion of the Scientific Committee on Medicinal Products and Medical Devices on “the Protection Offered by Natural Rubber Latex Medical Devices

THE STATE OF THE ART CONCERNING XENOTRANSPLANTATION Adopted by The Scientific Committee on Medicinal Products and Medical Devices

OPINION ON THE RISK QUANTIFICATION FOR CJD TRANSMISSION VIA SUBSTANCES OF HUMAN ORIGIN Adopted by The Scientific Committee on Medicinal Products and Medical Devices

In the mid-1990s, the spread of Bovine Spongiform Encephalopathy (BSE) to epidemic proportions in the United Kingdom created considerable concern among national and Community health and agriculture authorities. This worry was exacerbated in 1996 when the Creutzfeldt-Jakob Disease Surveillance Unit in Edinburgh identified a new variant of the disease (nvCJD) that exhibited characteristics linkin...

Scientific evaluation of herbal medicinal products by the HMPC.

On 31 May/1 June and on 21/22 July 2005, the Committee on Herbal Medicinal Products (HMPC), which was founded in September 2004, met for the 5th and the 6th time, respectively, at the offices of the European Agency for the Evaluation of Medicinal Products (EMEA). A number of guidance documents has been elaborated by the Committee’s drafting groups on organisational matters, on quality and on sa...

The committee for advanced therapies' of the European Medicines Agency reflection paper on management of clinical risks deriving from insertional mutagenesis.

In the European Union, the Committee for Advanced Therapies of the European Medicines Agency takes the lead in the scientific assessment for marketing authorization applications for advanced therapy medicinal products, which include gene therapy medicinal products, somatic cell therapy medicinal products, and tissue-engineered products. The Committee for Advanced Therapies also takes the lead i...