La U.S. Food and Drug Administration (FDA) ha publicado los fees aplicables para el año fiscal 2026 dentro del programa OMUFA (Over-the-Counter Monograph Drug User Fee Program), que afectan tanto a las instalaciones que fabrican medicamentos OTC bajo monografía como a las empresas que soliciten modificaciones en una monografía existente.

The U.S. Food and Drug Administration (FDA) has announced a significant regulatory update affecting the labeling and use of food color additives in the United States. The agency has introduced a new enforcement policy allowing more flexibility for “no artificial colors” claims, while also approving additional natural color additives to support industry reformulation efforts.

Understanding what qualifies as an OTC drug, how OTC monograph’s function, and what regulatory obligations apply is essential for companies planning to enter the U.S. market.

From a regulatory perspective, this amendment is part of the UK’s ongoing process of maintaining alignment with technical updates introduced under Regulation (EC) No 1223/2009, while implementing them through domestic legislation.

The new regulation repeals and replaces the long-standing Detergents Regulation (EC) No 648/2004, aligning the rules with current scientific, environmental, and digitalisation priorities.

The European Commission has officially confirmed that the first four EUDAMED modules will be mandatory from May 28, 2026 . Read more at our post!