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
We are glad to present you a current digest of the most significant bills, regulatory changes, and measures affecting the pharmaceutical and healthcare industry for the period from June to October 2022. Follow the link to download the digest. ALRUD_Newsletter_Key_changes_in_Life_Sciences_for_the_June-October_2022_period_upd ...
On November 7, 2023, Ohio voters passed Issue 2, a measure that will legalize the purchase and use of recreational marijuana. By passing this initiative, Ohio becomes the 24th state to legalize recreational marijuana. Issue 2 creates Chapter 3780 of the Ohio Revised Code. This new law will become effective on December 7, 2023 ...
Institutional Shareholder Services, Inc. (“ISS”) and Glass, Lewis & Co. (“Glass Lewis”) recently released their 2019 proxy voting policy updates. ISS and Glass Lewis are two of the leading proxy advisory services worldwide, and each evaluates and updates their proxy voting policies annually. The key ISS and Glass Lewis updates for the 2019 proxy season are summarized below. ISS ISS published its 2019 Proxy Voting Guidelines Updates on November 19, 2018 ...
Under the patent statute, any person who “invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent,” subject to the conditions and requirements of the law. The word “process” is defined by law as a process, act, or method, and primarily includes industrial or technical processes. The term “machine” used in the statute is self-explanatory ...
Through Resolution 2020012926 of April 3, 2020, INVIMA formalizes the measures adopted in connection with the person to person attention and proceedings that will be carried out before the entity during the health emergency, as well as the suspension of terms for some of INVIMA´s actions ...
INVIMA will prioritize the procedures for pharmaceutical products identified as essential for the treatment of symptoms and complications of COVID-19 ...
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 ...
The COVID-19 pandemic has exposed the difficulties in reacting at European level to a major health crisis and the intention of the European Commission is to respond more effectively to future problems in the area of health. As a result, it is currently conducting an initial assessment of possible legislative changes in the area of medicinal products for human use ...
Due to the active spread of coronavirus infection COVID-2019, the Russian authorities, at both the federal and regional levels, are taking significant measures to ensure the self-isolation of citizens. These measures include increasing the liability for violation of measures for preventing the spread of coronavirus infection, which caused adoption of a number of legislative acts. 1 ...
The currently unstoppable strong spread of COVID-19 and the resulting restrictions on public life, such as quarantine measures and curfews, which are imposed in EU Member States and worldwide and which are sometimes very drastic, are also increasingly impairing the ability to work and communicate. In the meantime, various IP Offices have also reacted to this. 1 ...
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 ...
With the Universal Community Testing Programme for COVID-19 detection by the Hong Kong Government and temperature screening in the workplace, the collection and use of biometric data (such as DNA samples, fingerprints and facial images) have raised concerns among the public. In August 2020, the Privacy Commissioner (PC) has updated its guidance note on how data users should collect and use biometric data in compliance with the Personal Data (Privacy) Ordinance (Guidance Note) ...
As the regulation system on human genetic resources ("HGR"), biosecurity and laboratory animals is experiencing continuous improvement, enforcement actions of the Ministry of Science and Technology ("the MOST") have become more active and tight in recent years ...
China began legislating the protection of human genetic resources in 1998, at which time the Ministry of Science and Technology (MOST) and the Ministry of Health jointly formulated the Interim Measures for Administration of Human Genetic Resources; however, there had been no corresponding implementing rules to implement it in practice ...
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 ...
On November 16, 2020, the Department of Health and Human Services Office of Inspector General (HHS OIG) issued Special Fraud Alert: Speaker Programs (Fraud Alert) to “highlight the fraud and abuse risks associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies ...
The U.S ...
In this report, you will find a summary of two important decrees published yesterday in the Official Gazette. Regulatory Decree of Law No. 27,350 of medical and scientific research on the medicinal use of the cannabis plant and its derivatives By means of Executive Branch’s Decree No ...
Regulators Expand Opportunities for Telehealth Services Under COVID-19 Shadow By: Phil Kim, Kayla Cristales, and Jennifer Kreick As the COVID-19 pandemic surges and the social distancing imperative continues, regulators have responded with various guidelines and policies that impact and expand the opportunities for telehealth services ...
More than two and a half years after the U.S. Food and Drug Administration (FDA) announced that it was reevaluating its regulatory framework for homeopathic products, the FDA released its Draft Guidance on Drug Products Labeled as Homeopathic. The Draft Guidance summarizes the FDA’s current enforcement perspective on homeopathic products and provides a list of the FDA’s enforcement priorities.The bills reawakened a debate about the pros and cons of POHs ...
Should States Embrace Telehealth Parity? Parity in telehealth is the notion that health services provided via telehealth technology should be treated equally as health services provided face-to-face. This is consistent with coverage parity, which requires payors to provide the same level of insurance coverage for patient encounters and services, while payment parity (a.k.a ...
In June 2022, at one of the annual meetings of the Employment, Social Policy, Health and Consumer Affairs (“EPSCO”) Council, health ministers expressed their concerns regarding the legislative transition to Regulation (EU) No 2017/745 of the European Parliament and of the European Council of 5 April 2017 on medical devices (“MDR”) and to Regulation 2017/746 of the European Parliament and of the European Council of 5 April 2017 on in vitro diagnostic medical devi
