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The impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
The impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’.
As the Brexit transformation and transitions are in full pace, the European Medicines Agency (EMA) is firm on releasing periodical updates for implementation of the Identification of Medicinal Products (IDMP).
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.
In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medicinal Products (IDMP) compatible authorized Human and Veterinary Products and Substances Management Services.
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region.
Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
If the latest government figures are any witness, the United Kingdom Life Sciences industry is a thriving £60 billion market, employing 220,000 people, and any potential threat to its growth is quite understandably worrisome.
Do you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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.
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