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Drug development is no cakewalk. Pharmaceutical companies are obliged to prove drug safety and efficacy to Regulatory authorities at every single stage of drug development. Based on the authority’s approval or disapproval only, the companies can further go into later stages of drug development and/or can relook into the entire developmental process.
On May 15, 2019, Central Drugs Standard Control Organization (CDSCO) of India has published a notification regarding the classification of new devices, which are notified for regulation. As per the notification, the newly regulated medical and in vitro diagnostic (IVD) devices will be classified as per the provisions of Medical Device Rules – 2017.
According to the Indonesian Law no. 33/2014, Cosmetics or Food Supplement manufacturers in Indonesia are required to obtain a halal certificate before their distribution in the country. The halal product regulations were supposed to come into effect from October 2019.
The Korean beauty market is valued at USD 13 billion, making it one of the top 10 beauty markets in the world and offering a pool of business opportunities for manufacturers. Most of the brands are successful in South Korea because rather than sticking to the classic brands, consumers prefer trying new products to suit their daily skin care routine.
For the third time in a row, the United States Food and Drug Administration (USFDA) has extended the compliance date for Type III Drug Master Files (DMFs) to be submitted in electronic Common Technical Document (eCTD) format.
Did you know? The US Food and Drug Administration (FDA) has set yet another high record by approving 106 novel devices in 2018, making it the most successful year for medical devices. With this accomplishment, FDA has surpassed its 40-year old record set in 2017 of approving 99 novel devices, showing a continuous growth for the past 8 years.
In 2017, 60% of the warning letters issued by the Food and Drugs Administration (FDA) were result of lack of data integrity. Referring to which, it is clear, how important is data integrity in any clinical trial.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
Artificial Intelligence (AI) is by far the most talked about technological advancement of this decade. Although the idea of AI has been around for years, the processers and computational speed of the previous era were not up to the mark, thus couldn’t support the analysis of huge data as required.
The global cosmetics production is one of the fastest growing industry globally, with a market size of USD 532.43 billion (in 2017). It is one of the few industries which is not much affected by the ups and downs of the global economic conditions. Even though the overall sale of the products is affected, the industry manages to maintain a steady sales volume.
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