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The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information.
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.
Times when patients are going through serious / immediately life-threatening conditions and physicians are left with no options except to opt for the investigational treatments, navigating certain processes would be challenging and time-consuming.
IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency) would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources.
In a general scenario, it is important to share the clinical trial analysis to increase the scope of further research and transparency in the flow of information. However, there are different levels of information that needs to be distributed to the public.
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.
The EudraVigilance Medicinal Product Dictionary (EVMPD) has undergone several changes and enhancements since its inception in the year 2005 until now. EVMPD has been revised and is now known as XEVMPD with enhancements that include increase in the data to be captured, revised controlled vocabulary and submission criteria.
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