On August 12, 2020, the United States Food and Drug Administration (USFDA) released a final rule for the labeling of food products falling under the category of fermented and hydrolyzed food.
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October 12, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory Affairs -
COVID-19 Regulatory Flexibility - HPRA Publishes Updated Implementation Time for Labels and Leaflets
September 16, 2020 Regulatory Labeling, Regulatory AffairsHealth Products Regulatory Authority (HPRA) of Ireland has released a temporary measure to extend the permitted implementation time for labeling and/or package leaflet updates from six to nine months. It is a temporary decision, implemented to ensure the availability of medicines in Ireland during pandemic.
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February 28, 2020 Regulatory Labeling, Regulatory AffairsThe pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle.
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February 28, 2020 Regulatory Artwork Services, Medical Devices, Regulatory Labeling, Regulatory AffairsTo ensure high standards of quality and safety for medical devices being produced or supplied, the European Union (EU) has released a new Medical Device Regulation (MDR) in May 2017. As the transition period for medical device manufacturers will come to an end from May 26th, 2021, organizations must relook at implementing compliant processes and procedures accordingly.
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February 27, 2020 Regulatory LabelingIt is evident that the labeling requirements in the European Union (EU) are quite dissimilar, given various region-specific regulations across the 27 member states. Besides this, the emerging European Regulatory landscape demands life sciences manufacturers to be more cautious in implementing and showcasing the safety information.
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December 31, 2019 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsIn 2016, the United States Food and Drug Administration (FDA) released final rules for the revised Nutrition Fact Labels, a part of which will be effective from the year 2020. It was initiated by the USFDA to help consumers make informed food choices and promote a healthy diet and lifestyle.
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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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October 18, 2019 Regulatory Labeling, Regulatory AffairsIn today’s rapidly changing global Regulatory scenario, companies must keep on par with evolving global label changes while creating, tracking, and managing different aspects of labeling((Please rephrase)).
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September 18, 2019 Regulatory Labeling, Regulatory AffairsIn Life Sciences arena, global health authorities always guide and mandate the manufacturers to demonstrate the safety and efficacy of a product through compliant labeling procedures. It is because the labels act as key channels of communication between the product and the end user.