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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.
Today 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.
It is tough for Pharma companies to be cognizant of all existing global regulatory requirements owing to the ever changing worldwide regulations and legislations. New procedures are always being developed and adopted by regulatory authorities worldwide due to the international harmonization process.
HISTORY OF REGULATORY INTELLIGENCE (RI)
Back 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.
AN OVERVIEW
Regulatory 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.
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
FDA 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.
Back in 2012 a standard set of procedures, guidelines and agenda was established by Australia’s Therapeutic Goods Administration (TGA) in a bid to implement the submission of medicine applications using the electronic Common Technical Document (eCTD).
The stats
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).
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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