A few weeks ago, The Economist published an excellent article that drew a contrast between the trade protectionism dominating U.S. politics and the more proactive trade agendas being pursued by other countries, such as the...more
The U.S. Food and Drug Administration’s (FDA) commitment to expand mutual reliance with trusted regulatory partners may be a silver lining for biomedical innovation during an unprecedented public health emergency. ...more
Recent regulatory developments of interest to all financial institutions. Includes COVID-19 and Brexit-related updates, and more. ...more
The pharmaceutical supply chain is extremely complex and relies on manufacturing sites located throughout the world. The COVID-19 pandemic has placed significant strain on this complex system. ...more
In a 3-1 decision, the National Labor Relations Board (Board) in Johnson Controls, Inc., 368 NLRB No. 20 (July 3, 2019), adopted a new standard that applies to an employer’s anticipatory withdrawal of union recognition, and...more
The European Commission and the Personal Information Protection Commission of Japan have agreed mutual adequacy decisions regarding the transfer of personal data. This is a significant development, and allows businesses to...more
The European Commission has issued an "adequacy decision" in respect of Japan reducing the regulatory burden of transferring personal data from the EU to Japan. Japan has made an equivalent decision for transfers to the EU....more
Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”)....more
Earlier yesterday, FDA announced that it has determined that the regulatory authorities of Austria, Croatia, France, Italy, Malta, Spain, Sweden, and the United Kingdom are “capable of conducting inspections of...more
Hotels differ from other types of stabilized properties in several major ways. The purpose of this article is to highlight how the distinguishing factors impact the way that owners and lenders approach the negotiation of key...more
On 4 March 2017, the agreement between the EU and the US governing the reciprocal recognition of GMP inspections of manufacturing sites for medicinal products for human use was published in the Official Journal of the EU:...more
This Hong Kong regulatory update is intended to provide a brief overview of the principal Hong Kong regulatory developments in the preceding three months relevant to companies listed or proposed to be listed on The Stock...more
On 22 May 2015, the Securities and Futures Commission of Hong Kong (SFC) and the China Securities Regulatory Commission (CSRC) signed a Memorandum of Regulatory Cooperation on Mainland-Hong Kong Recognition of Funds, which...more
Until now, eligibility for a Customs-Trade Partnership Against Terrorism (C-TPAT) certification has been an importers only program. Now a plan is in the works to expand the program to exporters. One proposed benefit would be...more