e-labeling plays a critical role in the medical devices industry, as it ensures to improve operational efficiency, maintain brand consistency, obtain compliance and support business growth. Hence, the device industry is moving towards adopting end-to-end e-labeling life cycle procedures, starting from label content creation to review and approvals.
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December 9, 2020 Medical Devices, Regulatory Affairs, Regulatory Labeling -
October 22, 2020 Regulatory Labeling, Regulatory AffairsOn July 16, 2020, Japan’s Consumer Affairs Agency (CAA) revised the labeling standards for food products in the country. To do so, the CAA appointed a study group to discuss the current labeling system and make necessary changes in it. These changes aim to strengthen the labeling standards for food products in Japan, while streamlining their safe distribution.
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October 22, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsTo strengthen the safety of food supplements in South Korea, in July 2020, the Ministry of Food and Drug Safety (MFDS) proposed to add “Precautions for Use” warnings to the label of food products. The proposed changes are applicable to food products with nine categories of ingredients.
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October 12, 2020 Food and Food Supplements, Regulatory Labeling, Regulatory AffairsOn 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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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.