Search
Sharan Murugan
- Mar 2
- 2 min
EMA: QRD updation and Product-Information Templates Updation
The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...
44 views0 comments
Sharan Murugan
- Mar 2
- 2 min
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
18 views0 comments
Sharan Murugan
- Feb 22
- 2 min
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline "Guidelines For Medicine...
37 views0 comments
Sharan Murugan
- Feb 17
- 1 min
USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know
Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...
32 views0 comments
Sharan Murugan
- Feb 17
- 2 min
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...
34 views0 comments