News Category: Regulatory news
The HPRA is now offering a swift national scientific advice service to applicants in addition to the standard national scientific advice for human medicines. This new swift advice procedure enables the provision of answers to applicant questions on the quality aspects of a dossier 30 days after the submission of the request for advice.
This procedure has no requirement for a meeting between the applicant and the HPRA. The procedure intends to provide a simple and more expedited mechanism for applicants to request clarification of the regulatory framework, or the interpretation of that framework, in relation to the development of or the post-approval changes for medicinal products. It is anticipated that this simpler and faster advice procedure will further facilitate applicants during their decision making when compiling the required supporting packages for pre and post authorisation submissions.
To facilitate this new procedure, we have updated our Guide for National Scientific and Regulatory Advice and request form which can be found on our website.