Coping with Regulatory Pressure: Strategies for Success
By Rebecca Yeager, Export Solutions Regulatory Explosion – Drinking from a Fire Hose! The regulatory landscape has been changing recently. In fact, I find it hard to keep up - and I'm what some would call "experienced"! One day I told a coworker that I didn’t have a single simple question to answer that week! In fact, I said the same thing to a BIS licensing officer, and he agreed that there aren't many easy answers to this question. number: To date, 39 Federal Register notices have been issued to the U.S. Department of Commerce's Bureau of Industry and Security (BIS). In 2023, BIS published 44 Federal Register reports. The U.S. Department of State's Bureau of Defense Trade Controls has received 52 Federal Register notifications. Not to be outdone, the Office of Foreign Assets Control (OFAC) has issued 191 Federal Register notices! These Federal Register notices involve enforcement actions, proposed rules, final rules, supplements, and, in certain limited circumstances, the…
Argentina: Amendment to Regulatory Decree No. 206/2017
in short Adopted Decree No. 780/2024 published in the Official Gazette on September 2, 2024 (“decree"), Regulatory Decree No. 206/2017 and its subsequent amendments ("Regulatory ActAccess to Public Information Act No. 27275 ("law") has been modified. Among other things, the Act makes the following amendments to the Regulation Act: The Decree defines the scope of (i) public information, which does not include private data or data not in the public interest; (ii) documents, which is limited to any records generated, controlled or held within the framework of state activities, excluding Preparatory deliberations and working papers. The Act sets out the formal requirements for information requests. As for the exception to the provision of requested information within the framework of a request, the Decree clearly stipulates that the nature of confidentiality must be determined in advance by a proven act of the competent authority and shall be retained for 10 years from the date of its creation. The Act regulates the…
Global Financial Services Regulatory Guide
The financial services industry continues to undergo significant transformation, driven by rapid technological advances (particularly generative artificial intelligence and digital assets), increasingly onerous anti-money laundering and sanctions regimes, new ESG obligations, and continued consolidation within the industry. The impact of regulatory changes, implementation complexities and conflicting regulations across jurisdictions may expose businesses to heightened regulatory risk. Baker McKenzie Global Financial Services Regulation (FSR) Guide Completely revised in 2024 and covering more than 35 jurisdictions around the world, it is our broadest edition yet. The guide serves as a quick reference tool when distributing financial products and providing services to new markets, providing a comprehensive summary of the regulations that apply to banks and other financial services companies around the world. This expanded version includes the rapidly growing crypto-asset sector, anti-money laundering and counter-terrorism financing regulation, as well as extending regulation to critical third-party outsourcers. Given the pace of regulatory changes in this area, it is critical for market participants to…
Philippines: Central Bank of the Philippines issues regulatory
brief On July 19, 2024, the Bangko Sentral ng Pilipinas (BSP; Central Bank of the Philippines) issued Circular No. 1198 of 2024 on the Regulatory Framework for Merchant Payment Acceptance Activities (MPAA) pursuant to the National Payment Systems Act. The regulatory framework seeks to establish standards and best practices to safeguard customer funds and protect the rights of merchants when dealing with payment system operators (OPS) engaged in MPAA. BSP Circular No. 1198 takes effect on August 8, 2024, which is 15 days after the circular is published in a newspaper of wide circulation. BSP Circular No. 1198 sets out licensing and registration requirements applicable to OPSs engaging in MPAA, as well as special rules related to settlement, operations, information technology, anti-money laundering, counter-terrorism financing, counter-proliferation financing of weapons of mass destruction, and end-user protection. MPAA refers to the services provided to merchants to obtain payment for goods and services. These services include merchant acquiring; providing payment acceptance facilities and…
Singapore: Therapeutic Products Regulatory Update
brief On 31 July 2024, the Health Sciences Authority (“Human serum albumin") released updates to the Therapeutic Product Registration as part of its ongoing efforts to improve regulatory efficiency and enhance clarity of regulatory requirements and processes. The HSA regularly updates its regulatory requirements and processes to ensure they are efficient and clear for stakeholders. Such updates also reflect the HSA's ongoing engagement with key industry stakeholders, incorporating relevant feedback to further improve its processes and systems. On July 31, 2024, the HSA released key regulatory updates for therapeutic product registration: Implementation of GMP requirements for chemical preparation manufacturers The evidence requirement for Good Manufacturing Practice (GMP) compliance for drug substance (DS) manufacturers will be fully implemented on October 1, 2024. GMPE requirements state that new or generic drug applications (NDA or GDA) and minor modification applications (MIV-1) to add new DS manufacturers must be supported by evidence of GMP compliance required of the DS manufacturer. The implementation of the…
Deep-sea mining faces many regulatory hurdles
The global oceans cover 71% of the Earth's surface. Extracting various resources such as cobalt, copper, nickel, silver, gold or zinc from the seabed has huge potential for commercial mining. However, as with terrestrial mining, environmental issues are of paramount importance and it is becoming increasingly urgent to establish the rules of the game. Also read: Technological innovation drives sustainable mining operations Regulatory stability in any industry is essential for efficient and predictable growth. When companies clearly define the boundaries of what is permitted, the likelihood of litigation is low and business can proceed in an orderly manner. Deep sea mining is at a critical juncture, with the exploration phase now complete and the need to determine how mining can or should proceed in the future. Currently, deep-sea mining companies engage in so-called “shallow water” mining, extracting minerals such as diamonds or tin. The International Seabed Authority (ISA) is a UN regulatory body responsible for the development and protection of…
Driving sustainable development in the cement industry: Regulatory changes and
Cement is the foundation of modern infrastructure, a paradoxical pillar of our built environment, both literally and figuratively. While cement is an integral part of the construction of skyscrapers, bridges and roads, the global cement industry has a profound impact on the environment. Producing cement is an energy-intensive process that generates significant CO2 emissions, accounting for 8% of global CO2 emissions. This figure exceeds the carbon footprint of industries that are often considered more polluting, such as aerospace, highlighting the cement industry’s significant contribution to climate change. Also read: Sedex to launch three innovative tools in 2024 to help make supply chains more sustainable In response to growing social and regulatory concerns, governments and industry stakeholders are implementing a range of incentives and regulations to improve efficiency and reduce the environmental impact of cement production. Welding Alloys, a leading expert in cladding and hardfacing applications, is delving into the changing landscape to explore innovative solutions that can improve the cement…