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Research recommencing has been accelerated by ingenuity from Ukrainian policymakers and businesses in two key areas: law and logistics. Requirements on imports, packaging, storage and circulation of medical products and devices have been eased, while continuing to uphold product requirements for efficacy and patient safety.
Regulatory Compliance: Compliance with regulations must be fully understood by representatives. They must be familiar with the different national authorities; the Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regulations that govern the pharmaceutical marketing and sales.
9″ It will be interesting to see whether FDA tries to control carcinogenic TSNAs in tobacco products using an acceptable intake (AI) strategy, aligned with approaches applied to medicinal products for nitrosamines. He is currently a CMC consultant with an interest in impurities and safety‑based limits. 01 February 2023.
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