The British Pharmacopoeia (BP) Inhaled Products Working Party has published its recommendations for BP monographs for inhalation as of September 17, 2012.
According to the document, “Safety and efficacy are critical considerations; the Working Party has taken the view that the inhalation monographs would ensure products that are safe and efficacious by maintaining a standard set of quality tests which should be determined. These are defined within the Ph. Eur. ‘Preparations for Inhalation’ general monograph (0671).”
A second document containing responses to stakeholder comments finds that, “The response to consultation suggests that the recommendations made in the Draft Policy Document are generally supported and that harmonisation with the requirements of the Ph. Eur. are welcomed.”
Proposed implementation dates for the recommendations range from 2013 to 2015.
Read the policy document.
Read the response to stakeholder comments.
