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Over the past few decades, Pharmacovigilance (PV), has been instrumental in detecting, assessing, understanding and preventing adverse events. In the due course, drug manufacturing organizations have implemented safety and PV systems with due diligence to stay compliant with Health Authority (HA) requirements.
It is well known that, the Food and Drug Administration (FDA) has been working to implement the transition of biological products which are currently approved as drug products and are ‘deemed to be licensed’ as biologics under the Public Health Service Act on March 23, 2020.
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.
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.
Biological medicinal products have become the promising solutions in the prevention and treatment of several life-threatening, chronic diseases and health conditions. Realizing this scope, several pharmaceutical companies are venturing into producing biological products like never before.
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.
Chinese cosmetics market is the third largest in the global cosmetics industry only after Europe and the United States of America. With an approximate annual growth of 10%, the total value of the Chinese Cosmetics market retail segment is reported to be 260 billion yuan in the year 2018.
The global personal care products industry is currently valued at USD 13.2 billion approximately and is expected to grow furthermore in the coming years. With the increase in numbers, the United States Senate has proposed a Personal Care Products Safety Act, a bill, to strengthen the regulations of ingredients of personal care products and protect consumer health.
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.
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.
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