Month: <span>September 2023</span>

Month: September 2023

FDA – MoCRA – Cosmetic directory

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily. On September …

Thai Food and Drug Administration (FDA) updates on drug renewal

Thailand is preparing to open its first renewal period for drug marketing authorizations (MAs) since the passage of the Drug Act (No. 6) B.E. 2562 (2019). Before 2019, MAs for pharmaceuticals and vaccines in Thailand had lifelong validity. The 2019 Drug Act stipulated that all new MAs would be valid …

Poland – Life Sciences update on cosmetic products

In recent weeks, the Chief Sanitary Inspectorate (Główny Inspektorat Sanitarny, GIS) has been taking  an increasing interest in the safety of cosmetics.  In August 2023, two announcements were published on the GIS website regarding restrictions on the  composition and use of such products. In a communication dated 4 August 2023, GIS …

EMA updated guidelines on Publication of RMPs and their summaries

From 20 October 2023, EMA is publishing RMPs (main body and annexes 4 and 6) for all centrally authorised products: initial evaluations;RMP updates. EMA no longer publishes RMP summaries from the same date. The aim is to increase transparency of the safety review process for all centrally authorised products. The …

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