Regulation (EU) 536/2014 of the Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use introduced additional requirements for the labelling of investigational and auxiliary medicinal products, in particular, for unauthorised medicinal products, in order to eliminate divergences in approach among Member States ...
The issue of the Dubai Law No. 4 of 2022 regulating Virtual Assets in Dubai (VA Law) issued in March 2022 created a lot of buzz and further strengthened Dubai’s position as a global hub for digital assets. The VA Law also established the Dubai Virtual Assets Regulatory Authority (VARA) which was tasked with creating a legal framework for virtual assets sector ...
“Government efforts to manipulate markets and prices on consumer goods never work as intended, and in this case, would be counterproductive.” The waning days of summer signal the approaching midterm election season. Amid inflation, recession and voter discontent, it’s understandable that a group of congress members are anxious to put points on the board with a price-control scheme that they wrongly believe will lower prescription drug prices ...
<p>Dear valued clients, colleagues and friends,</p><p>Our <a href="https://www.shearndelamore.com/practice-areas/technology-communications/">TMT</a> Partner, <a href="https://www.shearndelamore.com/people/janet-toh-yoong-san/">Janet Toh</a>, and Associate, <a href="https://www.shearndelamore ...
On 31 August 2022, the UK COVID-19 Inquiry (“the Inquiry”) opened its second Module. Module 2 will examine the political and administrative decision making of the UK and devolved governments, with a particular focus on early 2020 ...
On August 31, 2022, the Cyberspace Administration of China (the "CAC") issued the Application Guidelines for Security Assessment of Cross-border Data Transfer (1st Edition) (the "Application Guidelines"), which specify and implement the provisions on cross-border data transfer security assessments ("security assessments") in the Measures for Security Assessment of Cross-border Data Transfers (the "Assessment Measures") ...
This summer, a major reform relating to personal data, in Russia, has been instigated. New privacy regulations entered into force on September 1st, 2022. These introduced a number of new requirements to data processing activities. Part of the new requirements, including new cross-border data transfer rules, will come into force from March 1st, 2023 ...
The strategy for the application of Portugal 2030 was designed around five main objectives of the European Union1: a smarter, greener, more connected, more social Europe that is closer to its citizens. At the national level, these strategic objectives of the European Union are embodied in four thematic agendas of the Portugal 2030 strategy2 ...
The Government of Vietnam issued Decree 53/2022/ND-CP dated 15 August 2022 (“Decree 53”) detailing a number of articles in Vietnam’s Law on Cybersecurity (2018) which took effect as from 1 January 2019 (“Law on Cybersecurity”). As with most laws in Vietnam, decrees and circulars and other subordinate legislation, provide more detailed information, forms, and other guidelines to help implement the law in an efficient manner ...
On 23 February 2022, the EU Commission proposed measures regulating the use and access of data, not being ‘personal data’ as understood by the GDPR, within the European Union across all economic sectors. The regulation of the use of data is essential given that data continues to be generated yet underutilised. The draft Regulation is to be read in conjunction with the EU’s Data Governance Act ...
SyCip Salazar Hernandez & Gatmaitan (SyCipLaw) has kept its Tier 1 ranking in M&A, and in Restructuring and Insolvency, in the latest launch of the IFLR1000 rankings, the guide to the world’s leading financial and corporate law firms. Earlier this year, SyCipLaw also received Tier 1 rankings in Banking, Capital markets: Equity, Project development, and in Project finance ...
The EU GDPR (Regulation 2016/679/EU) came into effect across the EU on 25 May 2018. Many organisations in the EU, including Malta, have now implemented measures to comply with this important law. However, there are many questions that are asked on a regular basis. This webinar will: 1 ...
In July, the Antimonopoly Committee asked the Ministry of Strategic Industries to update the conditions for providing state aid to companies that develop, manufacture, repair, and service aviation equipment and engines. What to update and how, the committee wrote in recently adopted recommendations . Asters lawyer Olena Gadomska told Mind what the latter envisage, why AMCU is resorting to such changes and who they will affect ...
Platform work entails the use of an online platform, serving as an intermediary between the clients and the workers for the performance of particular services or to carry out particular jobs in return for payment. In this way, division of work into specific jobs is favoured over a long-standing employment relationship ...
Kongkoch Yongsavasdikul, partner and co-head of startup practice, was invited to be a panel discussion speaker at the Chulalongkorn University Technology Center (UTC) on the topic “Key Legal Issues when Considering a Spin-off” to share his knowledge on the legal issues that investors should be aware of before considering a spin-off. Other panel speakers include Lect. Dr ...
With regulations imposing mandatory vaccination for certain workers in the care sector being implemented to those same regulations being revoked some four months later, employers in this sector may well be confused as to what options are available to them ...
Dear valued clients, colleagues and friends, We are pleased to bring you the latest legal updates for August 2022. Financial Services Securities Commission Malaysia Issues Consultation Paper on Proposed Regulatory Framework for Technology Risk Management by Capital Market Entities Islamic Financial Services (Minimum Amount of Capital Funds or Surplus of Assets Over Liabilities) (Licensed Person) (Amendment) (No ...
Thanyaluck Thongrompo, partner of Kudun and Partners, was invited to be a speaker at the Faculty of Business Administration, Maejo University on the topic “Digital Assets Law in Thailand” where she shared her knowledge and experience in handling digital asset matters in Thailand. This seminar is a part of the business administration students’ academic program that focuses on derivatives, with digital assets being one of the most popular topics of recent ...
As all court cases do, the Supreme Court's landmark decision in West Virginia v. EPA last month addressed a specific question: whether the Environmental Protection Agency had the statutory authority to shut down power plants and reshape significant parts of the energy sector in its effort to reduce emissions. The answer was a plain and simple no. Equally clear was the court's argument, which has implications for administrative actions well beyond this case ...
Proposal for a regulation of the European Parliament and of the Council on standards of quality and safety Current regulatory framework and scope of application The EU regulatory framework on substances of human origin (“SoHO”) is reflected in Directives 2002/98/EC for blood and 2004/23/EC for tissues and cells ...
August 15, 2022 By: Michael Flynn* Continuing a trend it has been pursuing, the CFPB on Thursday used a non-rulemaking circular (Consumer Financial Protection Circular 2022-04) to state that its UDAAP authority extends its enforcement authority to situations where financial institutions have insufficient data protection or information security. The circular may be found here ...
Dear valued clients, colleagues and friends, Our TMT Partners, Christina Kow and Timothy Siaw, have co-authored the Malaysian chapter of The International Comparative Legal Guides — Fintech 2022. The chapter covers a broad overview of the development of Fintech and its regulation in Malaysia. Click here to read more. This article was first published in the ICLG —Fintech.https://www.shearndelamore.com/publication/2022/FIN22_Chapter_26_Malaysia ...
On 18 July 2022, the UK government introduced the new Data Protection and Digital Information Bill (Bill). What is the Bill? The new Data Protection and Digital Information Bill contains the government’s proposals to reform the UK’s data protection regime. The Bill quickly follows the government’s publication in June of its response to its consultation on the Data Reform Bill carried out in Autumn 2021 ...
