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
The Agency for Medicines and Medical Devices BiH announced acceptance of documents for methods of administering / changes / renewal of the authorization in NeeS format. ALMBIH will accept NeeS submissions for any type of submissions relating to regulatory affairs, including: granting licenses, renewal, variation, transfer or revocation / withdrawal of the license, PSUR and […]
The eCTD version 4.0 EU M1 Implementation Guide is now available for public consultation, and the eSubmission Change Management Board invites all pharmaceutical companies, vendors of eCTD building and reviewing tools and competent authorities to take part in this consultation and provide comments by 22 May 2015.
The ICH M8 EWG was formed in November 2010 to assume responsibility for the continued development of the next major version of the eCTD. The M8 EWG has developed the draft of the ICH eCTD v4.0 Implementation Guide. This guide is now being made available as DRAFT Version 2.0 along with the draft ICH Code […]