Two years ago, in 2017, the Food and Drug Administration (FDA) identified a tentative list of Class II medical devices to be exempted from premarket notification requirements. The list came with limitations for certain type of devices then. Referring to the same, the FDA on Oct 24, 2019, announced the proposed final list of Class II devices to be exempted from 510(k) requirements.
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December 26, 2019 Medical Devices, Regulatory Affairs -
November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
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October 31, 2019 Medical Devices, Regulatory AffairsWith just six months for the EU Medical Devices Regulation (MDR) to come into full implementation, medical device manufacturers need to start and prepare for the significant changes coming up or they may be at a risk of getting their products removed from the EU market.
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September 27, 2019 Regulatory Affairs, Publishing & SubmissionsHealth Canada (HC) again postpones the mandatory deadline for Drug Master File (DMF) submissions in electronic Common Technical Document (eCTD) format. Referring to the authority’s May 2018 notification, the earlier deadline was Jan 1, 2019 which later got postponed to Sep 01, 2019.
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September 18, 2019 Regulatory Labeling, Regulatory AffairsIn Life Sciences arena, global health authorities always guide and mandate the manufacturers to demonstrate the safety and efficacy of a product through compliant labeling procedures. It is because the labels act as key channels of communication between the product and the end user.
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August 12, 2019 Compliance, Audit and Validation, Regulatory AffairsDo you know? To rely on each other’s Good Manufacturing Practice (GMP) inspections pertaining to human medicines, the European Union (EU) and the United States (US) have signed a Mutual Recognition Agreement (MRA) in 1998. However, despite a series of actions and progressive discussions, it was never operational. But the talks which began in 2014 led to revision of Annex in 2017.
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August 9, 2019 Regulatory Affairs, Publishing & SubmissionsIn July 2019, the European Directorate for the Quality of Medicines and Healthcare (EDQM) has announced that eCTD format shall be mandatory for all Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP) applications including notifications, revisions, renewals and new applications.
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July 10, 2019 Pharmaceutical, Regulatory Affairs, Publishing & SubmissionsDrug 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.
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May 30, 2019 Medical Devices, Regulatory AffairsOn 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.
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April 15, 2019 Food and Food Supplements, Cosmetics Regulatory Services, Regulatory AffairsAccording 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.