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…
Pharmaceuticals in general not only produce drugs but they also produce tons of data. Regulatory agencies across the globe insist on generation of data for each and every activity. We should understand that there is value in data generation. Data…
March 31, 2020 EMA has published its Regulatory Science Strategy to 2025 today. The strategy provides a plan for advancing regulatory science over the next five years, covering both human and veterinary medicines. It comes in response to the dramatic…
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