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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
On 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.
To 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.
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.
Health 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.
The 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.
To 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.
It 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.
In 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.
DYK? 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.
Medicine 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.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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