In the face of COVID-19 emergency, the European Medicines Agency (EMA) established faster scientific advice, rolling reviews and accelerated assessments to expedite the development and approval of medicinal products. EMA’s foresight is to support the development and marketing authorization of safe, effective and high-quality therapeutics and vaccines at the earliest.
July 30, 2018 Regulatory Labeling
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
November 9, 2017 Compliance, Audit and Validation
Between 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers. The number shows that there is significant rise in manufacturing violations when the health agency inspected respective facilities.
Draw a finite line
Are you geared up with blocked timelines and strategies for upcoming drug / cosmetic Regulatory mandate? Before deciding on your next task, recheck on the category of your product to be marketed. Is it a drug or a cosmetic? Draw a finite line and understand corresponding Regulatory implications and laws to ensure your marketing efforts won’t go in vain.