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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.
Sunscreen is an important component of an effective sun protection regime. They must be safe, effective, and of good quality. For this reason, the TGA regulates sunscreens as therapeutic goods in Australia under the Therapeutic Goods Act 1989. The Australian Regulatory Guidelines for Sunscreens (ARGS) describe the Regulatory requirements and standards for sunscreens and their ingredients.
Therapeutic Goods Administration (TGA), under the ‘Therapeutic Goods Act 1989,’ is entitled to regulate medical devices placed and marketed in Australia. Medical devices are regulated under the Therapeutic Goods (Medical Devices) Regulations, 2002. Initially introduced in 2002, the regulations underwent multiple amendments at a frequency of at least once a year, almost every year.
Health Authorities worldwide are initiating various programs to strengthen Adverse Drug Events (ADE) reporting of new prescribed medicines every day. An Adverse Drug Event (ADE) can be defined as any unfavorable and unintended sign, symptom, or disease associated with the use of a medicine. The safety and efficacy of new prescribed medicine is usually decided based on clinical trials.
The chemicals industry is one of Australia’s largest manufacturing sectors and a key enabler of almost every value chain. In Australia, chemicals are regulated under both territory/state and national laws. There are four (4) main Regulatory authorities for chemicals, and each authority focuses on a particular type of use.:
Have we ever realized various processes to consummate the sustainability of the products we manufacture? Won’t it be cumbersome to understand the depth of different market regulations for Food products?
On July 1, 2020, the National Industrial Chemicals Notification and Assessment Scheme (NICNAS) was officially replaced by the Australian Industrial Chemicals Introduction Scheme (AICIS).
COVID-19 outbreak necessitated an extensive study on the Personal Protective Equipment (PPE) regulations. Depending on the PPEs’ (face masks, gloves and gowns) therapeutic purpose, TGA has designed certain guidelines for manufacturers, consumers and healthcare professionals.
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.
Labeling, perhaps the most looked-after section of any product; either a medicinal product, medical device or a cosmetics product. As it furnishes the first-hand information about the product to the outside world, Life Sciences manufacturers across the globe are obliged to manage this piece of information as accurately as possible to win the end-user’s trust.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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