National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018.
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January 31, 2019 Medical Devices, Regulatory Intelligence, Regulatory Affairs -
December 27, 2018 Artwork Pack Management, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Nutraceuticals/Food Supplements, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority UpdatesThe 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.
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December 24, 2018 Regulatory Intelligence, Regulatory AffairsArtificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required.
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November 22, 2018 Regulatory Intelligence, Regulatory AffairsAs a big face lift, Health Authorities of China and South Africa have recently revealed their identifications. The China Food and Drug Administration (CFDA), has recently announced the change related to the agency’s official English name, the National Medical Product Administration (NMPA).
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June 7, 2017 Pharmaceutical, Regulatory IntelligenceWhen it comes to measuring the success of a new medicine, the amount of time taken to complete the entire approval process becomes a crucial factor. With the growing need to speed up the market launch and address the unmet needs of patients, major global health authorities have in turn accelerated the drug approval processes.
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March 2, 2017 Regulatory Intelligence, Regulatory ConsultingWading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety.
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January 24, 2017 Regulatory Intelligence, Regulatory Consulting, Health Authority UpdatesIn a recent announcement, the US Food and Drug Administration (FDA) asserted the ban on powdered medical gloves will come into effect, beginning 19 January 2017.
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January 19, 2017 Nutraceuticals/Food Supplements, Regulatory Intelligence, Regulatory ConsultingAbout ~2500 years ago, Hippocrates, the father of medicine, welcomed the belief “Let food be thy medicine and medicine be thy food”. But with the rapid emergence of modern drug therapy, the “food as medicine” philosophy gained dust in the 19th century. Come 1900s, the primary role that diet plays to promote health and prevent diseases came to the forefront once again.
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As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is worthwhile to reflect upon the influential industry trends, HA guidance documents and major industry challenges that we’ve been covering in the last 12 months.
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December 22, 2016 Artwork Pack Management, Cosmetics Regulatory Services, Freyr Announcements, Medical Devices, Nutraceuticals/Food Supplements, Pharmaceutical, Regulatory Intelligence, Regulatory Labeling, Regulatory Affairs, Regulatory Consulting, Publishing & Submissions, Health Authority UpdatesRegulatory Guidelines for the Pharma Industry, so far in ‘16