Ask a CFIUS Expert: Is Crypto Spying on Us?
Hot Topics in International Trade-Braumiller Law Group-FDI Into Mexico from China
4 Key Takeaways | Solar Industry & Chinese Tariff Update
10 Key Trade Developments: Trade Remedy Cases
Episode 309 -- Alex Cotoia on Compliance with the Uyghur Forced Labor Prevention Act
10 Key Trade Developments: China
Noteworthy Points in the Rules for the Implementation of China's Patent Law 2023
JONES DAY TALKS®: Corporate Compliance in Asia: Managing Rapid Regulatory Change and Ambiguity
Hot Topics in International Trade. Braumiller Law Group Partner & Founder Adrienne Braumiller joins Vp of Marketing Bob Brewer for an Update on Forced Labor
Episode 292 -- 3M's $6.5 Million FCPA Settlement with the SEC
5 Key Takeaways | How to Effectively Leverage the Chinese Patent System
Third Party Observation in Patent Prosecution in China
The Grace Period for Novelty in Chinese Patent Law
One Month to a More Effective Compliance Program with Boards – Day 14 - Boards and Doing Business in China
Episode 276 -- Review of Phillips and Franks Int'l SEC FCPA Settlements
Sanction and the Increasing Complexity of Trade Compliance
Braumiller Law Group Help With China Imports
Coming Conflict with China: Part 5 - Good Compliance Is Good Business
JONES DAY PRESENTS®: Taiwan's Enhanced Trade Secret Restrictions and Stricter Penalties
JONES DAY PRESENTS: The Challenges of Defending Trade Secrets in China
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
This article provides a general overview of certain Chinese legal considerations for licensing and collaboration deals in the life sciences industry. In particular, this article focuses on two types of transactions...more
After years of waiting, China’s Ministry of Science and Technology (MOST) finally released the final version of the Implementing Rules on the Human Genetic Resources Administration Rules (Implementing Rules) on 1 June 2023,...more
Life sciences companies engaged in early development programs face a number of strategic considerations, such as where and how to administer the early stage scientific studies and each phase of clinical trials that are needed...more
ACI is excited to welcome you back in-person to the 14th Advanced Forum on FCPA & Anti-Corruption for the Life Sciences Industry, taking place on July 21–22, 2022 in Boston! Legal and compliance professionals from...more
The Ministry of Science and Technology of China has finally issued the draft of Implementation Rules for the Regulations of Human Genetic Resources Administration for public comments on March 21, 2022, which gives more...more
The Administrative Regulations of the People’s Republic of China on Human Genetic Resources (the “Regulations”), promulgated by China’s State Council, have been in effect for almost three years. As the administrative...more
On July 1, 2019, the Administrative Regulations on Human Genetic Resources (人类遗传资源管理条例) (the “Regulations”) issued by the State Council of the People’s Republic of China (the “PRC”) came into effect. On October 17, 2020, the...more
Multinational pharmaceutical companies, by nature of their business, handle a great deal of data, often transferred across borders, whether based on research, clinical trial data, and employee personal data....more
Report on Research Compliance 18, no. 9 (September, 2021) - A former Harvard Medical School and Massachusetts General Hospital (MGH) researcher who was the principal investigator on a 2014 NIH award of $939,495.27 and...more
China recently amended its primary regulation governing medical devices, the Regulation on Supervision and Administration of Medical Devices (2021 RSAMD), which will replace its previous 2014 version and become effective on...more
On January 6, 2021, Everest Medicines (HKEX 1952.HK) announced that the National Medical Products Administration (NMPA) of the People’s Republic of China approved a Clinical Trial Application (CTA) for sacituzumab...more
In Tuesday's Report: changes in Italian trademark law; new insolvency trends in China; tips for corporate boards to prepare for crisis; potential conflicts of interest in U.S. COVID-19 contracts, and other Congressional...more
The medical device industry in China is highly-regulated and China adopts a “pre-market” recordation or approval system for medical devices. Before any medical device can be manufactured, imported, distributed, or sold in...more
The World Health Organization (WHO) has determined that the 2019 novel coronavirus is a “global pandemic” and President Trump has declared a national emergency as the impact of the virus on all aspects of daily life continues...more
Due to the COVID-19 emergency and the consequent lockdown that is affecting non-essential services in Italy, including some health care services, on March 12, 2020 the Italian Medicines Agency ("AIFA") issued a Guidance,...more
The pharmaceutical and biotech industries are assessing how the coronavirus (COVID-19) pandemic may impact business operations. Presently, most countries have confirmed cases of COVID-19 and thousands of people have had...more
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has issued guidance on the management of clinical trials in the context of coronavirus....more
How is the manufacturing, marketing, distribution, and sale of medical devices regulated in the People’s Republic of China? This article outlines the regulatory framework and pathways, the classification of devices, and...more
The past few weeks have seen the following biosimilar developments in China: ..On December 16, 2019, Qilu Pharmaceutical received approval in China for ANKADA, a biosimilar to AVASTIN (bevacizumab). ANKADA has been...more
Faster review periods and waiver of requirement for Chinese clinical trials are intended to encourage marketing applications - On 28 March China's National Medical Products Administration (NMPA) published a list of an...more
In an effort to increase the availability of pharmaceutical treatments in China, the China National Drug Administration has recently released guidelines to allow pharmaceutical drugs that have already undergone clinical...more
On April 26, 2018, the China Drug Administration (CDA) released a draft guideline of implementing rules on pharmaceutical data exclusivity for public comments. The draft guideline expands the scope of data protection from...more
This is the first time the China Drug Administration (CDA) provides details on how the data exclusivity applies to pre-clinical and clinical data submitted to the agency. Companies with plans to launch pharmaceutical products...more
On October 8, 2017, the General Office of the CPC Central Committee and the General Office of China's State Council jointly issued Opinions of the State Council on Promulgating the Reform of Review and Approval System for...more