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Han Kun Law Offices | September 2023

On September 7, 2023, the Center for Drug Evaluation (the "CDE") of the National Medical Products Administration (the"NMPA") released "Annual Report on Progress of Clinical Trials for New Drug Registration in China (2022)"(the"2022 Annual Report") ...

Dinsmore & Shohl LLP | September 2023

Recently, the U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) announced a settlement with L.A. Health Care Plan. With more than 2.7 million members, L.A. Care is the nation's largest publicly operated health plan, that offers Medicaid, Medicare and plans through the Affordable Care Act.  Under the settlement, L.A. Care agreed to pay $1 ...

Carey | September 2023

On August 28, 2023, Supreme Decree No. 61 (the "Regulation") was published in the Official Gazette, which approves the regulation of Law No. 21,349 on "Composition, Labeling and Marketing of Fertilizers and Biostimulants" (the "Law"). Content of the Regulation In general terms, the Regulation covers the following matters: Classification of fertilizers, biostimulants and blends, establishing requirements by class. Composition, quality parameters and labeling. Sampling and analysis ...

Carey | September 2023

According to Supreme Decree 12 dated June 8, 2020, issued by the Ministry of Environment ("DS 12/2020"), on September 16, 2023, collection and recovery goals and ancillary obligations for producers of containers and packaging (the "Producers") within the context of Law 20,920 ("EPR Law") will become enforceable. DS 12/2020 establishes, among others, the following obligations for the Producers: Register in the Pollutant Release and Transfer Register, and provide the information requested ...

Han Kun Law Offices | September 2023

On September 8, 2023, the China National Center for Biotechnology Development (the "CNCBD"), a public institution under direct charge of the China's Ministry of Science and Technology (the "MOST"), released the"Notice on Issuing Answers for Frequently Asked Questions on Human Genetic Resource Administration"(the "Updated FAQs"), which summarized and responded to questions that are constantly raised among the relevant industry (the "Industry") ...

With the objective of reducing the effects of climate change and guaranteeing access to energy in different latitudes, the figure of Energy Communities has been developed. These are legal organizations made up of a variety of partners that may include individuals, associations, small and medium-sized companies, government entities, among others. Climate change is a real existential threat that requires concrete and decisive action ...

Shoosmiths LLP | August 2023

The new biodiversity net gain (BNG) requirements are set to come into force from November 2023. This will legally mandate securing a minimum 10 per cent biodiversity net gain from new commercial and residential developments in England, with a few exceptions. While the requirements - part of the Environment Act 2021 – will have financial and operational implications, the real estate industry has had several years to prepare for BNG ...

Dinsmore & Shohl LLP | August 2023

The 5th Circuit Court of Appeals in New Orleans upheld parts of a Texas District Court ruling by restricting the use of Mifepristone, while allowing Mifepristone to remain on the market.[1] This is the latest ruling in an ongoing legal battle that has left the future of abortion medications in a state of flux. Dinsmore previously discussed the original April 2023 ruling that led to the most recent development ...

Han Kun Law Offices | August 2023

Recently, China's healthcare industry has been subject to a rigorous inspection and rectification initiatives focusing on anti-corruption. These initiatives have attracted widespread attention in the industry, and we have received numerous media and customer inquiries regarding such issues ...

Hydrogen is seen by many as the fuel of the future, a substance that can provide heat through combustion, or electrical power from fuel cells, emitting only water in the process. Its potential usefulness, specifically its ability to replace fossil fuels without generating greenhouse gases, makes it the poster child for clean energy.  There are various ways of producing hydrogen, but currently most of it is done in the most cost-efficient way, by steam reforming ...

Mamo TCV Advocates | August 2023

  Blood donation plays a critical role in healthcare, and with the continuous increase of the Maltese population, staff blood donation is becoming all the more important. Malta relies heavily on blood donations to meet the needs of its healthcare system. While voluntary blood donation is always encouraged, staff blood donation can help spur those who would otherwise be hesitant about donating blood or who might even have never donated blood before ...

Buchalter | August 2023

December 2015 By: Bailee Pelham "Previous research on the mental health of firefighters has shown that they are at a greater risk than the majority of the population to develop various mental disorders, such as depression, anxiety, alcohol abuse, suicidal ideation, and post-traumatic stress disorder ...

Dinsmore & Shohl LLP | August 2023

The Centers for Medicare & Medicaid Services (“CMS”) has announced its proposed rules for the Hospital Outpatient Prospective Payment (“OPPS”) and Ambulatory Surgical Center (“ASC”) Payment Systems, as well as its calendar year (CY) 2024 proposed Physician Fee Schedule (“PFS”), (collectively the “Proposed Rules”) ...

Carey | August 2023

On August 7th, 2023, President Gabriel Boric enacted the Law that systematizes Economic Crimes and Attempts against the Environment, and, among other modifications, expands the criminal liability of legal entities (“Law”). Consequently, the Law will come into force and will apply to all acts committed from the date of its publication in the Official Gazette ...

Shoosmiths LLP | August 2023

Property owners in the UK are already feeling the pinch, with a slowdown in activity coupled with economic factors, including high inflation and interest rates - causing a further tightening in the lending market. The Minimum Energy Efficiency Standard (MEES) regulatory regime is another cause for searching behind the sofa cushions for coppers in order to upgrade, update and 'green' existing assets ...

Dinsmore & Shohl LLP | August 2023

In its second tranche of major standards reduction, The Joint Commission will eliminate or consolidate 210 accreditation standards across many of its programs. The modification to the affected standards will be effective August 27, 2023. The reduction is part of a major review effort of Joint Commission requirements announced in September of 2022 ...

Han Kun Law Offices | August 2023

The concept of "patient-centered" has become the core guiding principle in current research and development ("R&D") of drugs. "Patient-centered" drug R&D refers to the process of drug discovery, design, implementation and decision-making based on the patient's point of view, with the aim of efficiently developing clinically valuable drugs that better meet the needs of patients ...

Dinsmore & Shohl LLP | July 2023

This year, the Federal Trade Commission (the “FTC”) and the Department of Justice (the “DOJ”) have been modifying antitrust guidance related to healthcare, and recently enacted three notable changes.  First, the FTC and DOJ jointly issued updated Draft Merger Guidelines (the “Draft Guidelines”) to address the way the agencies evaluate a merger to determine its effect on competition ...

Dinsmore & Shohl LLP | July 2023

On July 3, 2023, Ohio’s biennial budget bill[1] was signed into law by Governor Mike DeWine. In addition to major budget provisions, the bill also includes notable changes to Ohio’s Medical Marijuana Control Program (“MMCP”), the state program that regulates and licenses cultivators, processors, testing laboratories, dispensaries and medical marijuana cardholders. Beginning January 1, 2024, the MMCP will be under new management ...

Carey | July 2023

On July 13, 2023, Law No. 21,586 was enacted. This law amends Law No. 21,435 to extend the term to fulfill certain requirements set forth therein, and also amends the Water Code to introduce an administrative procedure to clarify and complete titles of water rights (“WR”). Amendments to Law No ...

Shoosmiths LLP | July 2023

On 13 July 2023, the UK government planned increases to fees across a range of immigration and nationality routes including the immigration health surcharge. The immigration health surcharge (IHS) is set to see a huge increase of around 66%. The current standard IHS rate is £624 per person per year of leave to remain granted and this will increase to £1,035. Similarly, the discounted rate for students and under-18s will increase from £470 per year to £776 ...

Han Kun Law Offices | July 2023

On July 14, 2023, the Ministry of Science and Technology of the PRC ("MOST") issued the Notice on Updating the Guidelines on Administrative Approval Items and the Scope and Procedures for Filing and Prior Reporting of Human Genetic Resources, which unveiled six documents, including the administrative guidelines on collection approval, biobanking approval, exportation approval and international collaboration approval of human genetic resources ("HGRs"), as well as the scope and procedures for int

Shoosmiths LLP | July 2023

UK REACH (Registration, Authorisation, Evaluation and Restriction of Chemicals) is the UK’s post-Brexit chemicals regulatory framework for the Great Britain (GB) market. It is regulated by the Health and Safety Executive (HSE) and has the overall aim of ensuring the protection of human health and the environment from the use of chemicals. UK REACH places responsibility for understanding and managing the risks associated with the use of chemicals on those who place them on the market (i.e ...

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