An electronic repository for periodic safety update reports (PSURs) and their assessment reports was launched by the European Medicines Agency (EMA). The central platform was created in accordance with the pharmacovigilance legislation of the European Union (EU) and will contain all information related to PSURs in the EU. It will facilitate the assessment of PSURs […]
Two Final Guidance for Electronic Submissions published by US FDA in December 2014 Providing Submissions in Electronic Format — Standardized Study Data https://lnkd.in/eUhwjj5
Following is the list of recent EMA”s updates with links to updated documents/guidelines:
US Food and Drug Administration (FDA) has proposed a new rule requiring biopharmaceutical companies to distribute product labeling information to healthcare providers electronically.
The specification for the Australian electronic Common Technical Document (eCTD) format submissions.
From 1 July 2015, new market authorisation applications for decentralised procedures must be submitted in electronic common technical document (eCTD) format.
Prescription medicine sponsors can now submit dossiers to the TGA (Therapeutic Goods Administration) in the electronic Common Technical Document (eCTD) format. Paper dossiers are no longer required to accompany eCTD formatted submissions, following the success of the pilot programme between January and June 2015. Paper dossiers are also not required to accompany Non-eCTD electronic Submissions […]
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 The final rule and accompanying draft guidance, Providing Submissions in Electronic Format—Postmarketing Safety Reports, applies to virtually all postmarketing safety reports for human drug and biologic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.