The European Pharmacopoeia (Ph. Eur.) Commission is consulting a wide range of stakeholders including industry, National Pharmacopoeia Authorities (NPAs), National Competent Authorities (NCAs) and Official Medicines Control Laboratories (OMCLs) on how the current situation with dissolution testing in Ph. Eur. Finished Products Monographs (FPMs) could be improved.
The purpose of this survey is to ask for feedback on possible approaches that the Ph. Eur. Commission could adopt, with an assessment of their advantages, disadvantages and potential impact. Completing the questionnaire here will only take a few minutes, but will provide the Ph. Eur. with invaluable information that will help shape the future of Ph. Eur. monographs on medicinal products containing chemically defined active substances.
The deadline for comments is 21 February 2019. Please do not hesitate to circulate this survey to other parties or individuals who may have an interest in this consultation.
Privacy notice: as the survey tool used is SurveyMonkey®, data may be hosted in the USA. Complete responses (with “contact details”) will be kept for 5 years maximum by the EDQM. Only responses without “contact details” will be shared with the members of the Ph. Eur. Commission and with the National Pharmacopoeia Authorities from the Ph. Eur. member states and kept for an indefinite period by the EDQM.