News & Analysis as of

Mutual Recognition Agreement

eCTD Format Required for all Mutual Recognition Procedure Submissions

by Hogan Lovells on

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

FDA to Rely on Drug Inspections Performed by Certain European Regulatory Authorities Beginning November 1, 2017

by Hogan Lovells on

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

Financing Hotels in the United States: Key Considerations

by Shearman & Sterling LLP on

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

Is the Oasis now a Mirage? Dwindling scope of the DIFC Courts' 'conduit jurisdiction'

by White & Case LLP on

Recent decisions of the Judicial Tribunal and the Dubai Court of First Instance limit the scope of the DIFC Courts' 'conduit jurisdiction'.   ...more

EU - US mutual recognition of GMP inspections: agreement published

by Hogan Lovells on

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

Hong Kong Regulatory Update - June 2015

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

Launch of Mutual Recognition of Funds Between Mainland China and Hong Kong

by K&L Gates LLP on

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

Exporters will soon be able to take advantage of C-TPAT benefits! BIG news

by Baker Donelson on

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

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