China's National Medical Products Administration (NMPA) released the 2023 Drug Review Annual Report on its official website on February 4, 2024, closely followed by the 2023 Medical Device Registration Annual Report on February 5. According to the public information, more than 60 innovative drugs have been approved by NMPA from 2022 to 2023, and a total of 61 innovative medical devices have been approved in 2023 ...
Since 2013, the National Medical Products Administration ("NMPA")Center for Drug Evaluation("CDE")has been releasing a Drug Review Annual Report ("Report")each year, which summarizes its work on drug review of the previous year ...
As we near the second year of the COVID-19 pandemic, trademark maintenance deadlines in 2021 create new obstacles for registrants. To maintain a federal trademark registration, registrants must periodically file an affidavit of use under Section 8, swearing that the mark is in use in commerce or that the registrant has an acceptable excuse for nonuse. Recent office actions show that the U.S ...
On November 16, 2020, the Office of Inspector General of the Department of Health and Human Services (OIG) issued a Special Fraud Alert addressing the fraud and abuse risks of speaker programs that are commonplace in the pharmaceutical and medical device industries ...
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 ...
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 ...
Introduction On 21 January 2021 a new royal decree was published in the Official Gazette which has temporarily extended occupational doctors' role in combating the COVID-19 pandemic in the workplace ...
In the light of the current geopolitical situation, including severe counter sanctions and restrictions imposed by the Russian Government, we would like to provide you with an update on the current IP regulation in Russia. Partial legalization of parallel imports On 29th March, the Russian government issued a Decree No ...
Important notification of four new guidelines for the compilation of mandatory codes of practice, which are binding in terms of the Mine Health and Safety Act 29 of 1996 (“the MHSA”).Kindly take note that on Friday, 5 February 2016, notices were published in Government Gazette No ...
When is an agricultural lease not an agricultural lease? An agricultural lease provides a tenant with various rights, including security of occupation for the agreed length of the lease. That might be for five or 10 years or longer under a fixed duration tenancy or even for the foreseeable future, if the lease is a traditional lease entered into before November 28 2003. However, not every lease of land is an agricultural lease. Whether it is or not depends on the purpose of the lease ...
As much of Oregon faces another year of drought, water experts say farmers and ranchers should be aware of all the tools available to them under the state's water rights laws. At a seminar Tuesday, Elizabeth Howard, Oregon water law attorney, and Lindsay Thane, natural resources attorney, both of Schwabe, Williamson & Wyatt, spoke about nine tools for farmers through the state Water Resources Department, or OWRD ...
Within the agricultural and food supply chain, significant imbalances in bargaining power between suppliers and buyers of agri-food products are frequent. Those imbalances in bargaining power are likely to lead to unfair trading practices. The Directive 2019/633 (the “Directive”) aims to ensure that agri-food companies are protected against these unfair practices. Scope of the Directive The Directive’s scope is very limited ...
In recent months a Customs Destination Certificate (CDA, in its Spanish acronym) will be required for medical devices1that do not have a sanitary registration to be imported into Chile. The CDA must be requested and obtained by the importer through the Institute of Public Health’s (ISP, id.) GICONA 2.0 electronic platform, and will require the payment of an official fee corresponding to the service code 4111027, “Customs Destination Certificate, law 18,164” ...
Regulation (EU) 2017/745 of 5 April came into force on 26 May to create a single set of rules applicable to all medical devices, other than in vitro diagnostic medical devices. Here are some of the main changes to the rules that now come into force: 1. Broadening of the scope of application of the rules and of the concept of medical device With this Regulation, medical devices without a medical purpose that have characteristics similar to medical devices (e.g ...
Over the past years, the Minister of Agrarian Affairs and Spatial Planning/ Head of the National Land Agency (“Minister”) has issued several regulations on location permits due to the progressive system established by the government for the efficiency of investments and licensing. After the Online Single Submission (“OSS”) system became applicable, the Minister issued Regulation No ...
On March 16, 2021, Decree No. 64 / 2020 of the Ministry of Economy, Development and Tourism, was published in the Official Gazette, approving the Regulation that establishes conditions for the treatment and final disposal of wastes from aquaculture activities (the "Regulation") ...
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains. This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies ...
In March 2022, the Oregon legislature passed House Bill (HB) 4002, which imposes new overtime pay requirements for agricultural workers beginning on January 1, 2023. The bill also establishes a refundable tax credit for eligible employers to help offset all or part of the additional wage expenses attributed to overtime pay ...
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 ...
Introduction A plant variety right (PVR) is an IP right which rewards breeders of new plant varieties for their efforts in creating those varieties. The current PVR law dates back to 1975 and is based on the 1961 International Convention for the Protection of New Varieties of Plants. The convention has since been amended several times, most recently and radically in 1991 ...
Water and wastewater agencies gained an important new protection from lawsuits challenging their rates on Wednesday, when Governor Newsom signed SB 323 (Caballero). For water or sewer service fees or charges adopted after January 1, 2022, this new law requires any lawsuits challenging those fees or charges to be commenced within 120 days of the effective date ...
Eliminating Kickbacks in Recovery Act Overview On October 24, 2018, Congress enacted the Eliminating Kickbacks in Recovery Act of 2018 (EKRA) as part of the SUPPORT Act, which is a comprehensive attempt to combat the opioid epidemic. EKRA established an all-payer anti-kickback prohibition that extends to arrangements with recovery homes, clinical treatment facilities, and laboratories. Unlike the Anti-Kickback Statute (AKS) under 42 U.S ...
Recently the “guideline for the supervision and regulation of the nutritional composition of foodstuff and its advertisement (“the guideline”) was published by the Undersecretary of Health.The guideline´s main objective is to, “guide the process of supervision and regulation of foodstuff”, taking into consideration the upcoming implementation of Decree No. 13 (June 27, 2016), which modifies the Health Regulations for Food Products ...
The European Council has just adopted a new dual-use regulation. The new dual-use regulation is a recast of the current dual-use regulation and aims, among other things, to modernize European export controls in a number of areas. The regulation is directly applicable in all EU Member States and is expected to enter into force in 2021. In this Insight, Plesner's export control specialists outline the main changes resulting from the new dual-use regulation ...
Please be informed that a new Counter-Sanctions Regime of Making Payments in IP-Related Agreements in Russia was established by the Presidential Decree No. 322 dated May 27th, 2022 “On the temporary procedure for fulfilling obligations in respect of certain right holders” (“Decree No. 322”). It came into force on the date of signing. Download the file to see more. https://alrud ...
