The withdrawal of the United Kingdom from the European Union had many concerns. One of them being Regulatory Submissions. To smoothen the submissions process, the EU and the UK have set up a clear set of rules. Many of them are related to the existing and new marketing authorisation applications (MAAs) for CAPs, DCP and MRP, Batch testing, QP Certification, etc.
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May 11, 2021 Regulatory Affairs, Publishing & Submissions -
February 9, 2021 Pharmaceuticals, Medical Devices, Food and Food Supplements, Chemicals, Consumer Healthcare, Regulatory AffairsThe 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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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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October 6, 2020 Compliance, Audit and Validation, Pharmaceuticals, Regulatory Intelligence, Regulatory AffairsAs we all aware, COVID-19 pandemic resulted in the suspension of regular on-site inspections and as the world is slowly coming out of COVID-19 restrictions, Health Agencies are eying on resuming the on-site inspections.
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September 30, 2020 Compliance, Audit and Validation, Regulatory AffairsTo support manufacturers during COVID-19, the EMA has updated guidance on the Regulatory expectations for the medicinal products. A new section of temporary flexibilities is added to inputs on good manufacturing practices (GMP), and good distribution practices (GDP). The new development is aimed at responding to the increased demand for medicinal products amid COVID-19.
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September 28, 2020 Pharmaceuticals, Regulatory AffairsWater is considered as a key ingredient in many pharmaceutical and life sciences operations. It is widely used as raw material, ingredient, solvent, active pharmaceutical ingredient (API), intermediate product, and in the formulation/manufacture of pharmaceutical products.
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June 11, 2020 Medical Devices, Pharmaceuticals, Regulatory AffairsIn 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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May 4, 2020 Regulatory AffairsWith the prevailing COVID-19 pandemic, the Regulatory bodies are propelled to take quick and flexible Regulatory actions. Accordingly, EMA has called for a new system of issuing electronic certificates for human and veterinary medicines. Proposedly, the Agency will no longer provide printed certificates, but only the electronically signed and authenticated certificates.
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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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March 4, 2019 Pharmaceuticals, Regulatory Artwork Services, 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.