As per Swissmedic the new M1 eCTD Specification (v1.3) and validation criteria (v1.3) have been edited, expanded and updated. The M1 folder structure and file naming have been modified. With a view to future eGov portal developments, a number of validation criteria have been adjusted or added in v1.3.
The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling.
These are few of the questions raised by Webinar audience regarding Periodic Safety Submissions Reports (PADER/PAER) in eCTD Q 1. Is ICSR so called MedWatch Forms? Ans. ICSRs are Individual case safety reports that carries information on adverse event(s) reported for drug and can be submitted in XML format. MedWatch is FDA Form 3500A, a […]
The European Medicines Agency (EMA) and the European Commissions Directorate General for Health and Food Safety (DG SANTE) have agreed with the Swiss Agency for Therapeutic Products (Swissmedic) and the Swiss Federal Department of Home Affairs (FDHA) to share non-public information on the safety, quality and efficacy of medicines, already authorised or under review, both […]
South Africa (ZA-MCC) has a plan to start accepting dossier in eCTD format, From 1st June 2015 eCTD is open for entire industry. ZA-MCC released the eCTD Module 1 Specification, version 1.0 and Validation Criteria version 1.0
To accommodate several change requests submitted since version 2.0 was in force September 2013, a revision of the EU eCTD Module 1 Specification has taken place and is now published as a draft version 3.0 for public consultation. The updated specification (highlighted and clean) versions with relevant release notes and comments template are now available […]
EMA just released the new dossier requirements for Centrally Authorized Products (CAPs). Effective, tomorrow 1 July 2015, all CAP submissions to CHMP members should now be sent via the EMA eSubmission Gateway. This means that all CHMP members will be able to access the submissions via the Common Repository.
South Africa (ZA-MCC) has a plan to start accepting dossier in eCTD format, From 1st June 2015 eCTD is open for entire industry.
As Regulatory Focus has extensively reported in the past, FDA has long been interested in making it easier for all drug companies—not just innovative manufacturers—to update the safety labeling on drug products.
FDA releases PDF specifications version 4.0