The pharmaceutical supply chains are highly complex, with multiple stakeholders like manufacturers, suppliers, technology providers, packaging partners, and retailers obliged to maintain the Regulatory standards for quality, safety, and procedural accuracy throughout the product lifecycle.
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February 28, 2020 Regulatory Labeling, 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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February 27, 2020 Publishing & SubmissionsOn August 3, 2017, the committee of the Eurasian Economic Union (EAEU) published the standards for electronic submissions of drug applications. With respect to same, the Board of the Eurasian Economic Union released two important ‘Decisions’ on the electronic submission format, which mandates the applicants to provide more detailed information.
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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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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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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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March 4, 2019 Regulatory Artwork Services, Pharmaceutical, Regulatory AffairsThe impact of Brexit is evident in almost every industry based in the European Union (EU) and the United Kingdom (UK). Pharmaceutical industry too not to be spared.
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February 14, 2019 Medical Devices, Pharmaceutical, Regulatory AffairsArtificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
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January 29, 2019 Pharmaceutical, Regulatory AffairsDid you know, as reported, every year almost 4500 drug products are called off from the US market? In the past few months, it is observed that the number of recalls has been increased drastically.
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January 22, 2019 Regulatory Affairs, Regulatory Medical WritingWhile researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.