As 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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October 6, 2020 Compliance, Audit and Validation, Pharmaceutical, Regulatory Intelligence, Regulatory Affairs -
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 Pharmaceutical, 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, Pharmaceutical, 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 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 18, 2019 Publishing & SubmissionsThe impact of Brexit has been a major topic for debates amongst the industry experts for the past two years. It has left companies on both the sides, the United Kingdom (UK) and Europe, hanging on a loose thread. As the date of Brexit is drawing closer, industries are aggressively looking for contingency plans for sustaining their business, if the UK leaves with a ‘no-deal’.
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September 5, 2018 PharmaceuticalAs the Brexit transformation and transitions are in full pace, the European Medicines Agency (EMA) is firm on releasing periodical updates for implementation of the Identification of Medicinal Products (IDMP).
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November 7, 2017 Regulatory Labeling, Health Authority UpdatesDo you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.