.png
)
December 14, 2023 The European Commission (EC), the Heads of Medicines Agencies (HMA) and EMA have published the first version of the Union list of critical medicines. It contains more than 200 active substances of medicines for human use considered…
Pharma is a highly regulated industry. Regulatory audits are an integral part of the drug regulations. Any pharmaceutical industry having a global presence undergo numerous audits in a year by various regulatory agencies. This not only affects their productivity but…
Against the backdrop of globalization, especially in case of pharmaceutical industry, data integrity has become one of the basic expectations that a regulator expects from a manufacturer. USFDA, MHRA, WHO or any other regulatory agency when inspecting an offshore manufacturing…
Parametric release is defined as the system of release that gives the assurance that the product is of the intended quality based on information collected during the manufacturing process and on the compliance with specific GMP requirements related to Parametric…
May 21, 2020 Regulators from around the world have agreed three priority areas for cooperation on observational research during COVID-19. They will collaborate on pregnancy research, on medicines used in clinical practice and on vaccine safety and effectiveness monitoring.…