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NEWS
The Drinking Water Inspectorate, Environment Agency, Natural Resources Wales and Ofwat have published their first joint Water Industry Performance Insights report, combining evidence on drinking water quality, environmental performance and customer service in England and Wales to strengthen transparency and oversight. Drinking water tests met required standards in 99.97% of cases, while internal sewer flooding fell by 43% in recent years. Leakage declined over the longer term, but further reductions are needed as pressure on water resources increases. Supply interruption performance improved, although some customers continued to experience lengthy disruptions. Pollution remained a concern, with 2,991 incidents recorded in 2025, including 84 serious incidents. Companies completed 93.7% of required environmental improvement actions on time, leaving 142 planned actions undelivered. Regulators will use financial penalties, enforcement action and improvement plans to address failures and oversee more than £104 billion of planned investment between 2025 and 2030.
NEWS
Seventeen departments such as the Department for Science, Innovation and Technology (DSIT) and Department for Education (DfE) have published their letters to regulators involved in the oversight of AI requesting an update by 30 April 2024. This includes the main digital regulators forming the Digital Regulation Cooperation Forum (DRCF), along with key regulators responsible for healthcare, finance, education, and the enforcement of human rights.
GLOSSARY
An authority which regulates any aspect of the planning, construction, operation and decommissioning of a nuclear power plant.
GLOSSARY
A system of approvals that must be specifically given by the ONR before an operator can continue with the construction or operation of a nuclear power plant.
GLOSSARY
Defined in the Code by reference to the FCA Handbook, namely a primary information provider (known as a PIP) approved by the FCA under FSMA 2000, s 89P.
GLOSSARY
The electronic information dissemination service operated by the London Stock Exchange. RNS has been approved by the FCA as a Regulatory Information Service.
PRACTICE NOTES
Introduction The regulation of senior managers in the financial services industry went through a seismic shift when the Senior Managers and Certification Regime (SM&CR) was first introduced to the banking industry in March 2016. It has since been expanded to encompass insurers (in December 2018) and since December 2019, it also applies to almost all other financial services firms. The intention behind the creation of the SM&CR was to encourage a fundamental change in the compliance culture across the financial services industry following the global financial crisis. The SM&CR seeks to strengthen the individual accountability of senior managers by making it easier for the Financial Conduct Authority (FCA) and/or the Prudential Regulation Authority (PRA) to hold them to account for the failings of their firms. The SM&CR also has a wider impact on all employees of financial services firms through the Certification Regime and the code of conduct that all employees (other than ancillary staff) must comply with (Conduct Rules). For practical guidance materials on the SM&CR, see Practice Note: Senior Managers and Certification
NEWS
Law360, London: Insurance brokers in the UK pay an average 3.3% of their annual revenue to cover regulatory costs, compared with only 1.9% paid by insurers, according to research published on 1 May 2025 by consultant London Economics.
GLOSSARY
Refers to the data exclusivity period granted by Article 10(1) of Directive 2001/83/EC, in which pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation for a generic product.
PRACTICE NOTES
Directive 2001/83/EC (the Pharmaceutical Code) establishes a period of ‘data exclusivity’ from the initial authorisation of innovative medicinal products during which the pre-clinical and clinical trial data generated and used to support the authorisation of an innovative medicinal product cannot be referred to by an applicant for a marketing authorisation (MA) for a generic product. Data exclusivity therefore serves to offer a guarantee to innovative companies that scientific data generated for the MA of the innovative medicinal product is protected and will not be used to assess applications from manufacturers of generic or biosimilar medicinal products until after expiry of the data exclusivity which the innovative medicinal product enjoys. This period of data exclusivity is also known as regulatory data protection (RDP). This Practice Note provides an overview of the applicable EU provisions governing RDP of MAs for innovative medicinal products and explores how it impacts on the entry of generic and biosimilar medicinal products into
PRACTICE NOTES
The highly regulated nature of the life sciences industry gives rise to a myriad of potential regulatory enforcement actions for breach of the ethical rules and laws governing the sector. There needs to be an awareness about the obligations of compliance. In some cases, those impacted by regulatory enforcement may wish to challenge such decisions. Enforcement can require a life sciences business to take costly remedial action, pay substantial fines and may attract significant adverse publicity. It may also give rise to difficulties with contractual and commercial relationships; it is also important that those who are regulated navigate ongoing regulatory relationships appropriately. Businesses that operate across the UK and EU need an awareness of domestic expectations and the approach of local regulators. Clients face rising enforcement risk, overlapping regimes and real personal and corporate exposure. Regulatory enforcement risk in life sciences is no longer siloed. When things go wrong, the consequences are fast, public and expensive. This Practice
PRACTICE NOTES
This Practice Note provides an overview of the regulatory fees and levies that authorised firms in the UK are required to pay towards the maintenance of the regulatory system. Why and how are fees and levies imposed? As independent bodies, the Financial Conduct Authority (FCA) and the Prudential Regulatory Authority (PRA) do not receive any funding from the government. Each regulator is empowered to levy fees on the regulated community to fund their work. Regulatory fees provide the FCA and PRA with the resources they need to carry out their statutory functions under the Financial Services and Markets Act 2000 (FSMA 2000). The fees apply to a structure of 'fee-blocks', each of which covers a different sector of the financial services industry. This ensures consistency across the regulated community. Authorised firms can belong to more than one fee block and are charged a periodic fee in each fee block that they belong to. The fee-block structure aims to recover the costs the regulators incur in regulating each sector. From an administrative point of view, the FCA collects