Invention has no limits. It is a continuous process. With many medicinal products and medical device rolled out in the market, the year 2019 has been a boon for Life sciences industry. For good, the industry has seen a significant growth. All thanks to the governance of global health authorities.
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December 26, 2019 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Regulatory Affairs -
November 26, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsDYK? Australian Regulatory framework for therapeutic goods has been evolving with regards to labeling requirements. It is clearly evident with the Therapeutic Good Administration’s (TGA’s) recent announcements and proposed labeling requirements. Recently, it has announced certain guidelines for using the ‘TGA assessed claim’ on medicine labels.
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October 31, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsMedicine labels act as a first-hand guide for the users and help to use the products qualitatively. Therefore, it is highly important to that the information available on the labels is consistent, easy-to-read and error-free, and on par with the global standards.
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August 30, 2019 Pharmaceutical, Regulatory AffairsAre you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels.
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July 16, 2019 Pharmaceutical, Regulatory AffairsOver the past few decades, Pharmacovigilance (PV), has been instrumental in detecting, assessing, understanding and preventing adverse events. In the due course, drug manufacturing organizations have implemented safety and PV systems with due diligence to stay compliant with Health Authority (HA) requirements.
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July 12, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsIt is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
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July 10, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsDrug development is no cakewalk. Pharmaceutical companies are obliged to prove drug safety and efficacy to Regulatory authorities at every single stage of drug development. Based on the authority’s approval or disapproval only, the companies can further go into later stages of drug development and/or can relook into the entire developmental process.
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March 4, 2019 Regulatory Artwork Services, 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 14, 2019 Medical Devices, Pharmaceutical, 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 29, 2019 Pharmaceutical, Regulatory AffairsDid you know, as reported, every year almost 4500 drug products are called off from the US market? In the past few months, it is observed that the number of recalls has been increased drastically.