Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
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April 2, 2015 Consumer Healthcare, Medical Devices, Pharmaceuticals, Publishing & SubmissionsToday regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies.
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December 11, 2014 Publishing & Submissions, Health Authority UpdatesBack in 2012 an ordinance was passed under which all the drug applications to the Saudi Food and Drug Administration (SFDA) were required to be processed through the electronic common technical document (eCTD). It was only till Jan.
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November 20, 2014 Publishing & Submissions, Regulatory Intelligence, Regulatory ConsultingRegulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision.
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Can more than one drug name appear in a CCDS? Who is the proper party to approve CCDS updates and revisions?This articles offers a framework and helps in understanding the role of the cross-functional teams and their undertakings that are involved in creation of a CCDS.
In Perspective
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August 5, 2014 Medical Devices, Regulatory Consulting, Publishing & Submissions, Health Authority UpdatesFDA has established a unique device identification number (UDI) so as to suitably distinguish medical equipment through their usage and distribution. Even though this system is now fully implemented in human-and-machine-readable form, the UDI compliance timelines are quickly getting shorter for companies to effectively plan their GUDID submissions to FDA.
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Drug Master File (DMF) is one of the important parts of the documents submitted to the regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).