What is ESG (Electronic Submission Gateway)?
The ESG has been setup by FDA for transfer of regulatory information in the form of eCTD, SPL, eDMF, etc..
The new Agency Gateway will enable the FDA to process regulatory information through automated mechanisms while it enables:
Study tagging file (STF) is an xml which contains the group of files for a particular study.
Study tagging files are required and applicable in US. Study tagging files applies to only module 4 and module 5 of eCTD.
The EMEA has published new EudraVigilance Business Rules for exchanging Safety/Acknowledgement Messages and Individual Cases Safety Reports (ICSRs) in the EEA in line with Regulation (EC) No 726/2004, Directive 2001/83/EC as amended, Directive 2001/20/EC, Volume 9A and Volume 10 of the Rules Governing Medicinal Products in the European Union.
Pharmacovigilance Good Practice Guide by MHRA is published by Inspections and Standards Division of the MHRA which assesses pharmaceutical companies’ compliance with UK and EU legislation which relates to the monitoring of the safety of medicinal products.
What is Pharmacovigilance?
Pharmacovigilance (PV) is the a science relating to the detection, assessment, understanding and prevention of adverse drug reaction or events or side effects of various pharmaceuticals drugs and medicines.