From June 20, 2014, the US FDA Stability guidance for ANDA submission will require 3 batches for every strength (three industrial scale or two industrial and one lab scale) and 6 months of accelerated stability Note: If 6 month accelerated stability show significant change and failure of any attribute, 6 month of Intermediate data are […]
In January 2014, CESG (Common Electronic Submission Gateway) is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the US FDA, to reduce regulatory burden for health products as part of the Canada-U.S.
The European Medicines Agency (EMA) reminds marketing authorization holders that from 1 March 2014 the use of the eSubmission Gateway or web client has become mandatory for all electronic Common Technical Document (eCTD) submissions through the centralized procedure
The EU eCTD M1 Specification v2.0 and Validation Criteria v5.0 will be required by EMA and National Competent Authorities in EU from 1 September 2013.
As part of its transparency initiative, which began in June 2009, FDA launched a website during the first week of January 2011 that addresses basic questions for industry about regulated products. The site addresses questions, such as, “How do I know if my product is regulated by FDA?” and “What should I expect during an […]
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: