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 […]
The US Food and Drug Administration (FDA) has issued draft guidance on the inclusion of Geriatric Information in Human Prescription Drug and Biological Product Labeling.
The UK has left the EU, and the transition period after Brexit comes to an end this year. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued a dozen documents explaining how medicines licensure will work after the Brexit transition period expires on 1 January 2021. From 1 January 2021, the MHRA will be […]
The US Food and Drug Administration (FDA) has made certain changes in the Manual of Policies and Procedures (MAPP) for reviewing the requests to consolidate previously approved generic drug applications.
The US Food and Drug Administration (FDA) has made effective a new manual of policies and procedures (MAPP) for transferring ownership of drug applications, including those due to corporate mergers and acquisitions.
European Union regulation proposed for relaxing genetically modified organisms (GMOs) requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.
China NMPA has issued drafts before the final release of the supporting documents for the “Measures for the administration of drug registration”, for public consultation:
The US Food and Drug Administration (FDA) revised its manual of policies and procedures (MAPP) to clarify when certain abbreviated new drug application (ANDA) amendments and supplements should be reviewed by the Office of Generic Drugs’ (OGD) Division of Filing Review (DFR).