The year 2020 has been unpredictable for all the industries across the globe, including life sciences industry. With the outbreak of COVID-19, the life sciences industry and global Health Authorities faced various challenging scenarios, which in turn affected their long-term Regulatory plans.
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February 9, 2021 Pharmaceutical, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory Affairs -
The year 2020 was a roller coaster for everyone across the world. With the outbreak of the COVID-19, global Health Authorities (HAs) have been working relentlessly to ensure that healthcare professionals and the general public have the best resources to fight this pandemic.
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September 17, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory AffairsPost-Brexit, the biggest challenge for the pharmaceutical industry is its potential implication on Regulatory affairs. The derogation as a result of post-Brexit is expected to hit the pharmaceutical industry extremely hard, especially the Pharma companies operating in the UK.
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May 6, 2020 Regulatory Affairs, Publishing & SubmissionsThe COVID-19 pandemic has disrupted all the industries across the world. To handle the situation carefully, certain proactive measures have already been rolled out. One among them is to properly sanitize the hands with over the counter available drugs such as Hand rubs and Hand Sanitizers.
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February 28, 2020 Regulatory Labeling, Regulatory AffairsThe 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 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.