The US Food and Drug Administration”s (FDA) Center for Drug Evaluation and Research (CDER) has released a new list of 90 guidance documents it plans to publish in 2015, including several long anticipated and eagerly awaited by members of the pharmaceutical industry.
FDA released GDUID Health Level 7 (HL7) Structured Product Labeling (SPL) Implementation Specification V1.3
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
USFDA 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. This guideline will be implement from last quarter of current year (2014)
In January 2013, CESG is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the USFDA, to reduce regulatory burden for health products as part of the Canada-U.S. If you are already registered with the FDA as a Trading Partner and now wish to do business with […]
The European Medicines Agency (EMA) reminds marketing authorisation 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 centralised procedure.
This form is to be used by industry stakeholders (e.g manufacturers of active pharmaceutical ingredients) who provide Drug Master Files (DMF) to the TGA, It is not required if the DMF is submitted in eCTD format.
ANDAs that have one major deficiency will automatically be refused, while it takes 10 or more minor deficiencies to derail an application. If a sponsor decides to correct the deficiencies and resubmit the application, it will be considered a new ANDA and require a new GDUFA fee.
The European Medicines Agency (EMA) has launched user-acceptance testing of updated electronic application forms (eAF) for centralised procedures of initial marketing authorisations, variations and renewals for human and veterinary medicines. Companies are invited to take part in the exercise and provide feedback on user experience with the updated forms.
As a first milestone, the submission of new marketing authorization applications in the Decentralized Procedure must be done using the eCTD format from 1st of July 2015 onwards.