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NEWS
The Medicines and Healthcare products Regulatory Agency (MHRA) Inspectorate has published a blog post reporting the results of its Route B substantial modifications pilot, conducted from 1 October 2025 to 31 March 2026. This pilot tested streamlined review processes for low-risk clinical trial modifications under section 11B of the Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2024, SI 2004/1031. The pilot received 94 registrations, with commercial sponsors accounting for 53% and non-commercial sponsors comprising 47% of the entries. A total of 26 applications were submitted from both industry and academia. The average end-to-end processing time for these applications was seven days, which is well below the targeted 14-day threshold and significantly shorter than the standard processing time of 35 days for substantial amendments. The streamlined pathway has become legally mandatory following implementation of the new Clinical Trials Regulations on 28 April 2026. Based on sponsor feedback during the pilot, the MHRA has amended the application process, modified the forms and simplified the guidance in preparation for full implementation.
NEWS
Law360, London: A solicitor accused of being a Chinese spy has lost her legal challenge against MI5, after a tribunal found 17 December 2024 that the UK security service acted lawfully when it warned parliamentarians that she was trying to interfere with the political process.
NEWS
The European Commission has adopted the texts of four Commission Delegated Regulations on asset-referenced tokens (ARTs) and e-money tokens (EMTs) relating to Regulation (EU) 2023/1114 on markets in crypto-assets (MiCA), which entered into force on 29 June 2023. MiCA will start applying on 30 June 2024 as regards Titles III and IV on issuers ARTs and EMTs respectively, and will fully apply as of 30 December 2024.
NEWS
The European Securities and Markets Authority (ESMA) has published the advice it received from its Securities and Markets Stakeholder Group (SMSG) on its consultation papers on reverse solicitation and the qualification of cryptoassets as financial instruments in the context of the Markets in Crypto Assets (MiCA) Regulation.
PRACTICE NOTES
Investment Firms Prudential Regime (IFPR), MIFIDPRU and the MIFIDPRU Remuneration Code For general information on the UK Investment Firms Prudential Regime (IFPR), see Practice Note: The UK investment firms prudential regime (IFPR). The IFPR is implemented in part by MIFIDPRU, and the MIFIDPRU Remuneration Code (SYSC 19G) (the Code), in the Financial Conduct Authority (FCA) Handbook. The Code sets out the minimum regulatory requirements in relation to remuneration for a MIFIDPRU investment firm that are appropriate and proportionate to the risks inherent in the business model and activities of the MIFIDPRU investment firm. The proportionality principle set out in SYSC 19G.2.4 R means that the content and level of detail of a MIFIDPRU investment firm’s remuneration policy may depend on a number of factors. These include the staff the firm employs, the different types of roles, the activities it carries out and whether the MIFIDPRU investment firm is part of a group with a group-wide remuneration policy. MIFIDPRU Remuneration Code—categories of firms and levels of remuneration requirements MIFIDPRU divides investment firms which are prudentially regulated by the
GLOSSARY
The countries Mexico, Indonesia, Nigeria and Turkey.
MIT
GLOSSARY
A treaty between more than two states (or groups of states) that seeks to encourage reciprocal investment by investors of the parties, including providing for rights and protections for foreign investors and investments, and how any disputes that may arise are to be resolved (aka investor-state dispute settlement or ISDS).
GLOSSARY
Multilateral investment treaties
NEWS
The Measuring Irregular Migration (MIrreM) project has launched a new database estimating that between 2.6 and 3.2 million irregular migrants live in 12 European countries, including the UK. The MIrreM Public Database on Irregular Migration Stock Estimates, developed by the University of Oxford and 17 partner institutions, provides insights into irregular migration across Europe and North America. The UK is estimated to have the largest irregular migrant population in Europe at between 594,000 and 745 000, this made up 1.1% of the total population and 13.1% of the population born in countries outside of free movement protocols (third country nationals in the EU). This estimate, however, is from 2017 - it is commented that it may now be out of date and investment in 'long-term, cross-country work on irregular migration data is needed to draw more reliable conclusions.'
CHECKLISTS
The tables below summarises the following for merger control jurisdictions throughout the world: • deadlines for filing merger notifications, and • first phase (phase I) investigation deadlines. Deadlines to file notifications This table summarises deadlines for filing merger notifications from signing transaction documents or other triggering events. Time from signing (or alternative trigger event) Jurisdiction As soon as the parties agree in principle, or sign a non-binding letter of intent, to proceed with the intended merger Pakistan Once an intention to merge has been established Barbados 1 week Argentina (note—after closing under the current regime; pre-merger notification and clearance required from 17 November 2026, subject to the transitional exception)Faroe Islands 7 working days (note—the authority has waived this deadline in the past, in circumstances where the merging parties establish contact, provide a brief overview of the intended merger, and guarantee that the application will be made as soon as possible) Mozambique 2 weeks Yemen (note—from date of owners, partners, or shareholders of the entities involved in the transaction approving the transaction) 15 calendar days Bosnia
PRACTICE NOTES
A number of competition authorities around the world are amending their operations due to the impact of the coronavirus (COVID-19) outbreak. The table below summarises the situation in relation to merger control procedures in highlighted jurisdictions. Note–only jurisdictions that are known to have amended their procedures due to the coronavirus outbreak are included; unless stated below, there are no known changes to procedure. For coronavirus (COVID-19) related developments in relation to antitrust investigations, exceptions/exemptions and State aid investigations, see Coronavirus (COVID-19)—global behavioural, exemptions and State aid case tracker. Jurisdiction Merger control regime status update Albania The Competition Authority had postponed all meetings and hearings scheduled until 31/03/2020 to April 2020. All investigations were suspended until 31/03/2020. As of mid-April, the Competition Authority begun issuing merger clearance decisions.Merger notifications can be submitted via email. Angola All documents should be sent to the ARC by email; no face-to-face contact is possible. Argentina The CNDC had suspended all investigation deadlines; the suspension ended and deadlines resumed on 26/10/2020 Notifications to be submitted by email or
CHECKLISTS
This Checklist sets out those jurisdictions worldwide that have the power to review/require notification of transactions that fall below mandatory notification thresholds (excluding any sector-specific rules, or the application of general antitrust (behavioural) rules). For more details on notification thresholds, see further, MJ merger grid—jurisdiction. Jurisdictions where competition authorities have the discretion to review transactions below thresholds Below is a list of jurisdictions where competition authorities have the power to review/require notification of transactions that fall below mandatory notification thresholds (excluding any sector-specific rules or the application of general antitrust (behavioural) rules). • Angola • Argentina • Australia • Bahrain • Barbados • Belarus • Brazil (note—for up to one year after closing) • Bulgaria (note—for up to six months after closing) • Canada • CEMAC • Central African Republic • Chad • Chile (note—for