Vietnam, a country of 97 million people, has been widely recognized for its successful handling of the novel coronavirus outbreak. On January 27, as the country celebrated the Lunar New Year holiday, Prime Minister Nguyen Xuan Phuc declared war on the coronavirus, having said "fighting this epidemic is like fighting the enemy". The Prime Minister and his cabinet acted expediently in controlling the spread of the virus ...
Pharmaceuticals and medical devices in Malaysia are governed by the following main legislation and regulations:the Sale of Drugs Act 1952 (SODA 1952);the Control of Drugs and Cosmetics Regulations 1984 (CDCR 1984);the Dangerous Drugs Act 1952 (DDA 1952);the Poisons Act 1952 (PA 1952);the Medicines (Advertisement and Sales Act) 1956 (MASA 1956); andthe Medical Device Act 2012 (MDA 2012) ...
The Fintech LandscapeDevelopments in 2019 in terms of sectors were:Payments: Remittance was an area of significant growth in 2019, with a number of notable non-bank payments service providers receiving Remittance (Class B) Licences from Bank Negara Malaysia (BNM). MoneyMatch, the first graduate from BNM’s Regulatory Sandbox programme for incubating and ensuring the sustainability and regulatory compliance of fintech start-ups, was the first to receive a licence at the start of the year ...
It’s 8 am, and you just learned that a material cyber-incident occurred in your organization. You fire up your Incident Response Plan. You engage outside counsel, and outside counsel engages a forensic firm. Your company, your outside counsel, and your forensic firm all sign an agreement that the forensic firm will work at the direction of outside counsel ...
MDR postponement On 17 April 2020 the European Parliament decided to postpone the transition timeline to implement the EU Medical Device Regulation (MDR), which was set to expire on 26 May 2020, until 26 May 2021. The EU MDR postponement was published in the Official Journal of the European Union and entered into force on 24 April 2020 ...
“At a time when the flow of information is always expanding, this app is a smart alternative for users to stay informed about these topics without a flood of emails.”(Jean-Marc Ueberecken, Managing Partner). The CoVid-19 crisis as a trigger Arendt Insights is the only app dedicated to Covid-19 crisis management in Luxembourg. The first version of the app has been designed to give insight from Arendt experts, using the Covid-19 Solutions platform ...
On June 11, 2020, Resolution No. 29/2020 (“RES 29”) of the Chilean Economic Development Agency (“CORFO”), which approved the regulations that will govern the “Green Credit” program, was published in the Official Gazette. The RES 29 aims to endorse the investment in renewable energy projects during the economic contingency arising post Covid-19. (https://www.corfo.cl/sites/cpp/sala_de_prensa/nacional/10_06_2020_corfo_crea_credito_verde) ...
Congress recently passed the economic stimulus package referred to as the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), the Paycheck Protection Program and Health Care Enhancement Act (“PPPHCE Act”), and the Paycheck Protection Program Flexibility Act (“PPP Flexibility Act”). Ttogether, the CARES Act1, PPPHCE Act, and PPP Flexibility Act are called the “CARES Act” ...
On 27 May 2020 the Federal Council adopted the Ordinance on Protecting against Cyber Risks (OPCy, available in French and German), which is set to enter into force on 1 July 2020. This move is the next step in a series of measures taken by the Federal Council to adopt a new organisational structure and implement a national strategy to protect Switzerland against cyber risks (NCS, available in German, French, Italian and English) ...
Congress recently passed the economic stimulus package referred to as the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act1”), the Paycheck Protection Program and Health Care Enhancement Act (“PPPHCE Act”), and the Paycheck Protection Program Flexibility Act (“PPP Flexibility Act”). Together, the CARES Act1, PPPHCE Act, and PPP Flexibility Act are called the “CARES Act” ...
This time we address solutions from the front lines: devices for remote diagnostics which can improve effective detection of the coronavirus and also unburden the health service in other areas. These solutions can also serve as aproving ground for the regulatory approach to oversight of algorithms. The immediate inspiration for writing this text was asolution from the company StethoMe presented at the DemoDay organised by the MIT Enterprise Forum CEE ...
Incorporating climate reporting into new, post-COVID-19, strategies will not only help achieve net zero targets but early adopters will be at the forefront of gaining valuable expertise, market resilience and better returns. There has been much discussion about the economic model for the global effects of COVID-19 and for our transition out the other side ...
The purpose of this special report (the “Report”) is to inform the legal considerations and initial impacts that may affect the operation of a business as a result of the state of emergency for fourteen (14) days from March 16, 2020 (the “State of Emergency”) declared through Supreme Decree No ...
Last year, United States Patent and Trademark Office (USPTO) Director Andrei Iancu noted that artificial intelligence (AI) has the potential to “fundamentally chang[e]” “the legal concepts of inventor or author.”[i] The USPTO recently had cause to consider this issue. On petition, the USPTO considered whether an applicant can name an AI program as an inventor on a patent application ...
The Substance Use Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (“SUPPORT Act”)[1] was enacted on October 24, 2018. Among other things, the SUPPORT Act amended the Physician Payments Sunshine Act (“Sunshine Act”)[2] to expand the definition of “covered recipients”[3] for payment tracking and reporting purposes ...
In the age of social distancing, it is about time the law is changed to allow wills to be executed electronically.Ingenious lawyers all over the Commonwealth are dreaming up rigmaroles for the signing of wills amid the pandemic. An English law firm has suggested that the will be signed at a park bench, with witnesses lurking nearby, ready to rotate around the document ...
Natural products play an important role in pharmaceutical innovation. They are active components in many medicines. For example, nearly half of the small molecules used to treat cancer are natural products or directly derived from natural products.1 They are also components of vaccines. The pharmaceutical industry is constantly seeking access to natural products and the traditional knowledge associated with them ...
Industry solutions relying on artificial intelligence (AI)are growing faster than many had predicted. In addition to the important personal data protection considerations, another important question which this new and emerging technology is raising relates to the AI safety problems and their legal response. So far, the European Union and Bulgaria have not adopted legislation specifically tackling the AI phenomenon and in particular – the safety concerns associated with AI ...
As corporate policyholders continue to submit claims to their insurers for business interruption and related losses sustained from the COVID-19 pandemic, insurers appear to be denying such claims routinely where the policies at issue contain exclusionary language specific to viruses — whether in stand-alone virus exclusions or other types of exclusions ...
On May 7, 2020, the amendment to Decree No. 466 was published in the Official Gazette, which approves the Regulation of Pharmacies, Drugstores and other pharmaceutical establishments, regarding the sale of medicines through electronic means. Particularly, article 8 of said Decree is modified, in order to allow the electronic sale of medicines in pharmacies, incorporating the following sentence: "Pharmacies may dispense medicines through electronic means ...
The National Fisheries and Aquaculture Service (“Sernapesca”) has issued a series of resolutions. Resolutions No 672/2020 , No 725/2020 and No 805/2020 - that incorporate new measures to those indicated in Resolution No. 565 dated March 16, 2020 which authorized the adoption of certain measures in salmon farming centers in the context of COVID-19 ...
In the context of COVID-19 pandemic, the field (on-site) tax audits in Russia are currently postponed, but once all restrictions are lifted, the tax authorities can start auditing Russian companies and replenishing the National Budget by redoubling their efforts. The pharmaceutical industry could be in the focus of the tax authorities and, above all, they could start with auditing of the contractual structures used for organizing clinical trials and promotion of pharmaceutical products ...
Key Points: U.S. EPA is continuing to regulate and prevent sham COVID-19 products and devices from entering the market under FIFRA. EPA's distinction in regulating pesticide substances versus pesticide devices can cause confusion, but can be addressed if companies take proactive steps to ensure their product's compliance with the requisite legal framework, and self-report when in doubt. As noted in our prior alerts, available here and here, U.S ...
