The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
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February 9, 2021 Pharmaceutical, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory Affairs -
The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
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February 3, 2021 Pharmaceutical, Regulatory AffairsDuring unexpected emergencies, like COVID-19, conducting on-site pharmacovigilance (PV) inspections are not feasible due to travelling difficulties, orders from local authorities, and restrictions to accessing facilities justified by health hazards. Under such conditions, remote inspections would become the most preferable, replacing on-site inspections.
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December 3, 2020 Pharmaceutical, Regulatory AffairsThe NPRA Malaysia has updated, “Guidance Notes for Active Pharmaceutical Ingredient (API) Information Required for Product Registration” - Version 5.0 (June 2020). The guidance helps API manufacturers to expedite the registration process. Further to this update, a temporary notice on mode of DMF submission has also been provided as below.
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October 13, 2020 Pharmaceutical, Regulatory AffairsAs it is quite inevitable that the transition period for the Brexit is not going to extend, numerous Regulatory changes or updates are expected to emerge from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). In the same context, MHRA has recently issued a guidance on pharmacovigilance procedures and post transition requirements for Qualified Person Responsible for Pharm
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October 8, 2020 Pharmaceutical, Regulatory AffairsIt is a known fact that the UK has officially left the European Union (EU) on January 31, 2020 and it is in the transition period until December 31, 2020. During the transition period, all the pharmaceutical companies in the UK must abide by the EU pharmaceutical law.
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October 6, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Intelligence, Regulatory AffairsAs we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
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October 6, 2020 Pharmaceutical, Regulatory AffairsSince the discovery of nitrosamine impurities as human carcinogens in mid-2018, FDA has been investigating and conducting a detailed analysis of the impurities in human drugs and APIs.
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Health Based Exposure Limits (HBELs) - Regulatory Expectations and Challenges An Informative Webinar
October 5, 2020 PharmaceuticalPharmaceutical companies sometimes manufacture the products using multipurpose manufacturing facilities to develop different medicinal products. Production at such facilities may create potential cross-contamination and pose a risk on products’ safety and efficacy.
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October 5, 2020 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsAccording to the US Food and Drug Administration (FDA), a majority of prescribed pediatric drugs are not tested. To overcome serious shortage of pediatric drug testing, FDA has issued a final guidance that offers a comprehensive framework for planning and submission of applications for pediatric trials.