FDA issued a final rule on June 10, 2014, that requires industry to submit postmarketing safety reports in an electronic format. The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic products, which includes individual case safety reports (ICSRs) […]
XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website
1 September 2015, companies should use the XML delivery file for all PSUR submissions to the EMA via the eSubmission Gateway/Web Client website.
On June 10, 2014, the FDA issued a new rule which amended the requirements for biological LDRs. Under this new rule, applicants are required to submit LDRs to the FDA in an electronic format that the agency can process, review, and archive. This reporting requirement is effective as of yesterday, June 10, 2015.
US FDA has announced new drug registration guidelines of pharmaceutical product for eCTD submission- Module 1 Specification version 2.3 and eCTD Validation Criteria, version 3.1
The Drug Regulatory Authority of Thailand (Thai FDA) has initiated the acceptation of Pilot eCTD from October 2014 and authority has scheduled to receive the eCTD submission from May 2015.
The following National Competent Authorities such as Estonia, Iceland, Liechtenstein, Slovenia are now ready to receive Centralised Procedure submissions via the Common Repository only means no longer accept Centralised Procedure submissions on CD or DVD or via CESP. This will apply to all types of Centralised Procedure eCTD procedures, including ASMF submissions related to centrally […]
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.