Formac initiates procedure to obtain Scientific Advice from the European Medicines Agency
Leuven, Belgium - 14 February 2013 Formac Pharmaceuticals NV, a drug delivery company focused on developing innovative formulations for poorly water-soluble drugs, and its strategic partner W. R. Grace & Co, a leading global supplier of silica, today announced that they have initiated the process of obtaining scientific advice from the European Medicines Agency (EMA) regarding the use of Formac's proprietary Ordered Mesoporous Silica material as a new pharmaceutical excipient.
Companies involved in developing new drug products can request scientific advice from the EMA. The EMA gives advice to companies on the appropriate tests and studies in the development of a drug product. This procedure is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines, for the benefit of patients.
On 26 February, Formac and Grace will have a pre-submission meeting with the EMA expert panel in London. Formac and Grace will then submit the briefing book to EMA by 25 March. EMA is expected to issue a final advice letter in June of this year.