Australian medtech stakeholders call for regulatory improvements in Govt inquiry
This article was originally published in Clinica
Executive Summary
Many of the issues in an Australian government inquiry into the country's regulatory standards for approving medical devices are being addressed by ongoing regulatory reforms, but there is still a need to improve other areas such as device recalls, reprocessing of single-use devices and regulatory transparency.
You may also be interested in...
EMA Hopes New Requirement Will Make Companies Stick To Their Filing Plans
An additional form that marketing authorization applicants must now complete during the pre-submission stage emphasizes the importance of companies providing accurate information on their intended submission date.
EMA To Get The Ball Rolling On Making CTIS Global
The European Medicines Agency wants to further improve the visibility of data in the Clinical Trials Information System by establishing it as a World Health Organization primary registry.
EMA Presses On With Keenly-Awaited Guidance On How To Use Patient Experience Data
While the International Council of Harmonisation is developing a harmonized approach to patient-focused drug development, the European Medicines Agency has heeded calls for “prompt guidance” to support the systematic inclusion of patient experience data in regulatory submissions.