Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023
Holders of an active medical device establishment licence (MDEL) must apply to have their licence reviewed every year before April 1 in order to continue doing business. Those with a suspended MDEL are exempt from applying. An annual licence review (ALR) ensures that MDEL holders are: Adhering to regulatory requirements Maintaining their licence information up […]
According to FDA regulations, if an applicant wishes to pursue approval of its Abbreviated New Drug Application (ANDA), applicant must submit all materials required to fully address all shortcomings in the Complete Response Letter (CRL) within one year of the CRL’s issuance. The applicant must submit a request for an extension on or before the […]
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Revising abbreviated new drug applications (ANDAs) Labeling Following Revision of the reference listed drugs (RLDs).” In this guidance, FDA is providing information on How ANDA applicants and holders should monitor for changes to RLD labeling: The sponsor […]
Version 4.0 of the electronic Common Technical Document (eCTD) is the upcoming next major version of the electronic submission format. CDER and CBER plan to accept new applications in eCTD v4.0 format in 2023. The current version, v3.2.2, which is used by most global health authorities, including US FDA, EMA, Canada, Japan, and many others. […]
Taiwan Food and Drug Administration (TFDA) released guidelines for eCTD specification. Following countries such as the USA, EU, Japan, Australia, Canada and Switzerland, Taiwan will soon adopt the eCTD standard.
A meeting has been held by US-Food & Drug Administration for explaining the concept of new FDA form 3938 for the submission of Drug Master File to FDA. The agenda for the meeting was to explain the concept of Form 3938, the details of the form, purpose of the form, when should the form 3938 […]
The US Food and Drug Administration’s (FDA or Agency) has announced the date that they will no longer support electronic submissions using the Electronic Common Technical Document (eCTD) Backbone Files Specification for Module 1 Version 1.3, Comprehensive Table of Contents Headings and Hierarchy Version 1.2.2, U.S. Regional Document Type Definition (DTD) Version 2.01 after March 1, […]
TGA updated guidance for the baseline submission for converting their dossier format from paper, Common Technical Document (CTD) or Non-eCTD electronic Submission (NeeS) to electronic Common Technical Document (eCTD).
Cross labeling guidance is in response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens. The purpose of this guidance is to describe FDA’s current recommendations about including relevant information in labeling for oncology drugs approved for use in a combination regimen, including important considerations for cross labeling […]
United Kingdom has planned to join Australia, Canada, Singapore and Switzerland in a regulatory consortium after it separates from the EU (post-Brexit) possibly during the inception of next year, hence enabling companies to access all five markets through a single application. MHRA will commence its working in the group from 1st January, 2021 and this […]