On October 8, 2023, theScientific and Technological Ethics Review Regulation (Trial)("Scientific and Technological Ethics Regulation") was jointly published by the China's Ministry of Science and Technology ("MOST"), the Ministry of Education, the Ministry of Industry and Information Technology, and other seven (7) departments/institutions, which was followed by a press conference held next day by the MOST to respond to media inquiries ("Press Conference") ...
A patent landscape provides a bird?s-eye view of the patenting activity related to a specific technology. It can be an invaluable tool for your organization as the analysis of patent data reveals business, scientific and technological trends. Indeed, many industries increasingly rely on patent landscapes to provides a basis for understanding innovation activity in their field ...
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") ...
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 ...
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") ...
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 ...
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 ...
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
As the latest signal in the priority of the Duty to Report in Ohio, the State Medical Board has updated its Duty to Report video.[1] The video is offered by the Board for physicians to fulfill the mandatory continuing medical education (CME) component of the license renewal process in Ohio. Introduced in a new regulation on May 31, 2021,[2] the Board began mandating one hour of CME on the topic of the legal duty to report misconduct ...
On September 17, 2022, Exempt Decree No. 63 of the Ministry of Health was published in the Official Gazette, approving Technical Standard No. 226 of the Ministry of Health, which set forth the obligation to implement a data registration system that allows the traceability of medical devices when they are received by institutional healthcare providers ...
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings” ...
On 16 March 2023, in Joined Cases C‑438/21P to C‑440/21P, the Court of Justice of the European Union (CJEU) interpreted the concept of a ‘global marketing authorisation’. It held that Article 6(1) of Directive 2001/83 (the Community Code) sets out exhaustively the line extensions for which the marketing authorisations (MAs) will fall under the same global MA as the initial MA ...
On June 1, 2023, China's Ministry of Science and Technology ("MOST") officially released the Implementation Rules for the Regulation of Human Genetic Resources Administration ("Implementation Rules"), which will come into effect on July 1, 2023 ...
The EU regulator has harmonized the maximum levels for tetrahydrocannabinol (THC) in hemp seeds throughout the Union within the food contaminants framework. This EU harmonization puts pressure on conservative national food laws such as the Belgian Royal Decree of 31 August 2021, which treats hemp seeds as a prohibited food.The situation in Belgium, however, is changing to better align it with EU law ...
Introduction An EU Regulation on the making available on the Union market as well as export from the Union of certain commodities and products associated with deforestation and forest degradation (“Deforestation Regulation”) was agreed upon by the EU legislators in December 2022. The European Parliament has now green-lighted the Provisional Agreement at this month’s plenary session ...
Ohio legislators are once again attempting to transform the state’s medical marijuana control program after a similar effort stalled out last year. Proponents of the proposed legislation, Senate Bill 9, seek to expand medical marijuana access to Ohioans and revamp the structure of the current program. The proposal would establish the Division of Marijuana Control (“DMC”) under the Department of Commerce ...
Americans have increasingly accepted meat and dairy alternatives as staples in their daily diets. For example, recent market research shows that two out of every five U.S. consumers plan to purchase plant-based meat products in 2023. The prevalence of these forms of alternative protein has set the stage for a semantic — and potentially paradigm-shifting — dispute over the very meaning of the terms "meat," "milk" and "dairy ...
On 1 September 2023, the legal framework for seed farming in Russia will take effect. At present, lawmakers are preparing highly controversial regulations, which essentially aim to limit foreign investments in the Russian seed farming sector. The central idea is to implement a set of rules that require Russian companies involved in the production of agricultural plant seed varieties and hybrids to localize their activities (“Localization Rules”) ...
Namibia’s emerging green energy industry has the potential to create thousands of jobs and contribute billions to the country’s GDP. In November 2022, the Namibian Government released the Namibia Green Hydrogen and Derivatives Strategy Report (the “GH2 Strategy Report”) which drew significant attention from locals, who are anticipating the development of legislation for Namibia’s green hydrogen sector ...
On December 29, 2022, the Modernization of Cosmetics Regulation Act (“MoCRA”) was signed into law.[1] MoCRA is the first federal cosmetics law since 1938 and will impose a number of new requirements on cosmetic products and the facilities where they are manufactured. Specifically, MoCRA requires the Food and Drug Administration (FDA) to implement enhanced oversight and regulation of cosmetic manufacturing facilities and products by December 29, 2023 ...
Introduction Mdeon, the legally recognised Belgian ethical platform for healthcare professionals and the pharmaceutical industry, announced several new ethics rules applying from 1 January 2023. The present blog post discusses their practical importance for the broader healthcare community, and particularly (i) several new ethic rules in light of the ascendant trend of virtual and hybrid scientific events, and (ii) new maximum hospitality amounts that can be offered to healthcare professionals ...
Roger Royse Q&A: ESG, PE and IPO Prospects for Agtech in 2023 December 28, 2022 Haynes and Boone, LLP Partner Roger Royse was featured in an AgFunderNews Q&A about environmental, social & governance (ESG), private equity, and initial public offering prospects for agtech in 2023. Below is an excerpt: AFN: Tell us a few really noteworthy investment trends you saw in 2022 ...
In Ultima Services Corporation v. U.S. Department of Agriculture et al., Case No. 2:20-CV-00041, Ultima Services Corporation filed suit in the U.S. District Court for the Eastern District of Tennessee (Greenville Division) challenging the constitutionality of the Small Business Administration’s 8(a) Business Development Program ...
Hemp seeds have been eaten in the EU for a long time. The seeds may contain trace amounts of tetrahydrocannabinol (THC) because this cannabinoid is a natural constituent of the cannabis plant from which the seeds originate. The EU regulator has decided to harmonize the maximum levels for THC in hemp seeds throughout the Union within the food contaminants framework. Commission Regulation 2022/1393 of 11 August 2022 amends the annex to Regulation No1881/2006 on food contaminants to this effect ...
The past two years have seen significant growth in the number of mergers and acquisitions nationwide with many agriculture and farming business owners choosing to liquefy their assets and move on. At the same time, employers have had to cope with numerous challenges that have made the task of hiring and preparing I-9s for new employees more difficult. Some employers (unlawfully) stopped preparing I-9s for new hires altogether ...
