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.
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June 11, 2020 Medical Devices, Pharmaceutical, Regulatory Affairs -
February 27, 2020 Medical Devices, PharmaceuticalOn January 31, 2020, the United Kingdom (UK) officially left the European Union (EU) making the Brexit come alive. In the light of Brexit, the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have released certain Regulatory guidelines to ensure both pharmaceutical and medical device manufacturers are ready for the transition period.
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January 30, 2020 Food and Food Supplements, PharmaceuticalFood safety has always been one of the top priorities of the United States Food and Drug Administration (USFDA). Strengthening it more, the agency is now shifting its focus from responding to foodborne illness to preventing it.
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January 29, 2020 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, PharmaceuticalIt has been observed for long that innovation drives the life sciences industry, and this would continue perpetually. For the betterment of human health, there have been many innovative drugs/devices released into the market.
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December 26, 2019 Food and Food Supplements, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Regulatory AffairsInvention has no limits. It is a continuous process. With many medicinal products and medical device rolled out in the market, the year 2019 has been a boon for Life sciences industry. For good, the industry has seen a significant growth. All thanks to the governance of global health authorities.
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November 26, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsDYK? 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.
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October 31, 2019 Pharmaceutical, Regulatory Labeling, Regulatory AffairsMedicine 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.
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August 30, 2019 Pharmaceutical, Regulatory AffairsAre you a manufacturer of Prescription and Over the Counter (OTC) drugs? Then it is obvious that you are aware of the US Consumer Product Safety Commission (CPSC) regulations under which certain consumer products, including many prescription and OTC drugs are subject to special packaging standards, including Child-Resistant Packaging (CRP) Statements in drug labels.
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July 16, 2019 Pharmaceutical, Regulatory AffairsOver 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.
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July 12, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsIt 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.