Stay updated with breaking news from Gaining Access. Get real-time updates on events, politics, business, and more. Visit us for reliable news and exclusive interviews.
/PRNewswire/ -- The orthobiologics market research report has been added to Technavio's catalog. The market is anticipated to witness healthy growth at a CAGR...
Register to make submissions to the MHRA Submissions related to human medicines need to be submitted directly to the MHRA. From: Contents Print this page For applications that you plan to submit to the UK (for example, a Marketing Authorisation for the UK or GB market), you will need to submit the information through our national portals. For those regulatory submissions made through European procedures you will need to continue to submit via the EU portals (for example, CESP). The information on how to make submissions to the MHRA is for the following groups: all pharmaceutical c...
Guidance on submitting clinical trial safety reports How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs). From: Print this page You must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways: If you intend to submit SUSARs using one of the new reporting routes, you must register. For trials ongoing in both the UK and in European member states dual reporting is needed. You will need to report each SUSAR to both the MHRA and relevant member states, as well as ...