Regulatory news and experts insights.

India’s medical device regulatory framework continues to evolve. The Ministry of Health & Family Welfare has released the Draft Medical Devices (Amendment) Rules, 2026, proposing amendments to the existing Medical Devices Rules, 2017.

Directive (EU) 2026/805 of 30 March 2026 constitutes a major revision of the European Union’s water legislation. By simultaneously amending the Water Framework Directive (2000/60/EC), the Groundwater Directive (2006/118/EC), and the Environmental Quality Standards Directive (2008/105/EC), the text aims to align the protection of water resources with the European Green Deal’s “zero pollution” ambition.

The safety of cosmetic products is generally assessed from the perspective of human health, considering endpoints such as skin irritation, skin sensitisation, systemic toxicity, and endocrine disruption. However, the environmental properties of cosmetic ingredients are becoming increasingly important in substance assessment processes and product development strategies, particularly when selecting formulation ingredients.

China is revising its rules on new chemical substance registration, with a draft revision of the Measures for the Environmental Management Registration of New Chemical Substances, commonly referred to as China REACH. The draft was released by China’s Ministry of Ecology and Environment on 11 June 2026 and was open for public comment until 12 July 2026. Once finalised, the revised measures are expected to replace MEE Order No. 12 of 2020.

In pharmaceutical development, the preparation of CTD Tabulated Summaries is a critical component of regulatory submissions. These documents require scientific rigor, consistency, and accuracy, while also involving extensive data compilation, formatting, and verification activities.