The European Commission, along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December, 2020.
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August 25, 2020 Regulatory Affairs -
January 30, 2020 Regulatory AffairsThanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets.
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February 14, 2019 Pharmaceutical, Medical Devices, Regulatory AffairsArtificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
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January 31, 2019 Medical Devices, Regulatory Affairs, Regulatory IntelligenceNational 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 22, 2019 Regulatory Affairs, Regulatory Medical WritingWhile researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
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Drug Information Association (DIA), a US-based non-profit, worldwide association, has unveiled its second annual report. The report offers industry experts’ detailed views on trends they anticipate in the world of medical product development for pharmaceuticals, biotechnology and medical devices in 2014. This year, three trends seem to be striving to take the top place.