In July 2019, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced that eCTD format shall be mandatory for all Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications including notifications, revisions, renewals and new applications.
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August 9, 2019 Regulatory Affairs, Publishing & Submissions -
March 4, 2019 Artwork Pack Management, Pharmaceutical, Regulatory AffairsThe 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.
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February 18, 2019 Publishing & SubmissionsThe 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’.
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September 5, 2018 PharmaceuticalAs 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).
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November 7, 2017 Regulatory Labeling, Health Authority UpdatesDo 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.
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July 4, 2017 Health Authority UpdatesIn 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.
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May 4, 2017 Medical Devices, Health Authority UpdatesWith 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.
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January 17, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesLife Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
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November 17, 2016 Artwork Pack Management, Regulatory Labeling, Health Authority UpdatesIf 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.
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July 20, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesDo 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.