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EU: Drug precursors – EU legislation (revised rules)

EU: Drug precursors – EU legislation (revised rules)   The EU has announced a new legislative initiative to revise its rules on drug precursors. The proposal seeks to revise the legislation governing the monitoring of trade in drug precursors both within the Union and between the Union and third countries. It addresses a number of...

EU: Proposal for a directive to revise the Cybersecurity Act.

EU: Proposal for a directive to revise the Cybersecurity Act.   The EU Commission has extended the feedback period for a proposal for a directive to revise the Cybersecurity Act, clarify the mandate of the EU Agency for Cybersecurity (ENISA) and improve the European Cybersecurity Certification Framework to achieve better resilience. This proposal forms part...

EU: New ‘Pharma package’

EU: New ‘Pharma package’   The Council and the European Parliament have reached a deal on the new “pharma package,” a legislative overhaul designed to improve patient access to medicines and strengthen the competitiveness and fairness of the EU pharmaceutical sector. This comprehensive reform modernises EU pharmaceutical rules to ensure that safe, effective and affordable...

EU: Implementing Regulation on AI Regulatory Sandboxes

EU: Implementing Regulation on AI Regulatory Sandboxes   The EU Commission has published a draft Implementing Regulation on AI Regulatory Sandboxes. It lays down rules for the application of Regulation (EU) 2024/1689 of the European Parliament and of the Council as regards the establishment, development, implementation, operation and supervision of AI regulatory sandboxes. Under Regulation...

EU: One-year postponement of EUDR

EU: One-year postponement of EUDR   Under the position adopted by the European Parliament on 26 November, large and medium-sized companies will only need to comply with EUDR obligations from 30 December 2026, while micro and small enterprises will become subject to the new rules from 30 June 2027. The additional year is intended not...

EU: Simplification of EU rules for defence and sensitive security procurement

EU: Simplification of EU rules for defence and sensitive security procurement   The European Commission has launched a public consultation aimed at simplifying EU rules for defence and sensitive security procurement. This initiative responds to the commitment made in the Joint White Paper for European Defence Readiness 2030 to reassess EU defence-procurement legislation in 2026....

Philippines: New regulations of pharmaceuticals

Philippines: New regulations of pharmaceuticals   Philippines have published two new pharmaceutical regulations: Implementing Guidelines of the World Health Organization (WHO) Collaborative Procedure on the Registration of Pharmaceutical Products Approved by Stringent Regulatory Authorities (SRAs); Classification of Pharmaceutical Products Intended for Human Use Regarding the first issue, many countries—including the Philippines—continue to face difficulties in...

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