Why a Company Core Data Sheet (CCDS) is required and what is its significance for the marketing authorization holders (MAH).
- March 10, 2015 Pharmacovigilance, Regulatory Affairs
- March 4, 2015 Regulatory Affairs
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)
- December 11, 2014 Publishing & Submissions, Health Authority Updates
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. 3, 2015 that the non-eCTD electronic submission including NeeS format were allowed, and thereafter it was mandatory for SFDA to accept electronic CTDs.
- December 11, 2014 Regulatory Affairs
Most of the life sciences companies now face increasing consumer, portfolio, regulatory and operating challenges on a daily basis as they carry on their search for innovative health solutions. In order to create and sustain competitive differentiation and market dominance, the life sciences sector must meet the diverse challenges of your regulatory/life cycle strategy today while supporting innovations of tomorrow.
- December 11, 2014 Regulatory Affairs
AN OVERVIEW
- November 20, 2014 Publishing & Submissions, Regulatory Intelligence, Regulatory Consulting
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
- August 5, 2014 Medical Devices, Publishing & Submissions, Regulatory Consulting, Health Authority Updates
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.
- July 4, 2014 Regulatory Affairs
Quality by design (QbD) is based on sound science and quality risk management through which quality is built into products. Although the benefits of QbD are obvious, the industry has been relatively slow in adopting the concept because QbD often falls low on the list of immediate priorities and understanding.
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).
What is Drug Master File (DMF)