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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.
Animal testing has always attracted a lot of attention from the industry because of its controversial nature. From the last decade, Cruelty Free International (CFI) has been encouraging companies across the world to stop the testing of cosmetics on animals to create a harmonized, cruelty free global market.
Although digitization and Internet of Things (IoT) have together enhanced the performance of medical devices, they have also made devices prone to cyber vulnerabilities. The malware and spyware invading the devices are growing. The hackers are mining for loopholes in devices and related software that allow them to corrupt the devices to compromise user data by malfunctioning the devices.
According to a recent announcement by the Therapeutic Goods Administration (TGA), sponsors of medical devices have a new procedure to follow for certificate of free sale or export certificate. The new application format allows the sponsors to submit their applications and receive the certificates electronically without any hassle and delays.
Are you currently planning an eCTD (electronic common technical documents) submission to Australia? If you are intended to, then take a pause and look out for the changes which are to be done while preparing your dossier for the region.
Since 31st August 2016, the Therapeutic Goods Administration (TGA) is continuously working to update its guidelines for labeling of medicines supplied in Australia to ensure companies be aligned with international labeling best practices and reduce medication errors.
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements.
Back in 2012 a standard set of procedures, guidelines and agenda was established by Australia’s Therapeutic Goods Administration (TGA) in a bid to implement the submission of medicine applications using the electronic Common Technical Document (eCTD).
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