International Trade Health

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Health Alert (Australia) - June 29, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgments: Australian Capital Territory (ACT). Medical Board of Australia v Hocking [2015] ACAT 44 - The ACT Civil and...more

Real Guidance (Finally) On the Compliance Oversight Role of Boards

New guidance for boards of directors on what it means to have “reasonable oversight” for the implementation and effectiveness of corporate compliance programs could signal the beginning of a global trend towards more—and more...more

Health Alert (Australia) - June 15, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: New South Wales. O'Sullivan v Medical Council of New South Wales [2015] NSWCATAD 113 The New South Wales Civil and...more

Kyiv Tax Newsletter (Ukrainian)

Cancellation of the Military Tax on Currency Exchange Transactions - On 12 May 2015 the Verkhovna Rada of Ukraine adopted the Law of Ukraine “On Amendments to the Tax Code of Ukraine in Respect of the Military Tax” which...more

Kyiv Tax Newsletter

Cancellation of the Military Tax on Currency Exchange Transactions - On 12 May 2015 the Verkhovna Rada of Ukraine adopted the Law of Ukraine “On Amendments to the Tax Code of Ukraine in Respect of the Military Tax” which...more

U.S. OSHA and Health Canada continue “partnership” to coordinate labelling and classification of hazardous chemicals, implement...

Health Canada and the U.S. Occupational Safety and Health Administration (OSHA) have announced that they will “continue their partnership” to “align United States and Canadian regulatory approaches regarding labelling and...more

China Removes Price Ceilings from Most Drugs

Chinese consumers have long complained about high drug prices. To address this problem, in 2000 the Chinese government adopted a price ceiling system for drugs. At that time, the medical insurance system and the drug bidding...more

The Oman Update - The Official Gazette 1102

Sultani Decrees - Sultani Decree 20/2015 - Promulgating the GCC Common Law of Anti-dumping, Countervailing Measures & Safeguards. Sultani Decree 21/2015 - Granting Omani nationality to 288 named...more

Health Alert (Australia) - June 9, 2015

In This Issue: - Judgments; Legislation; and Reports. - Excerpt from Judgements: Australia. Fair Work Commission Marr v Western Health [2015] FWC 2970 The Fair Work Commission has held that it was...more

Congress Returns From Memorial Day Recess

The House and Senate return this week from the annual Memorial Day recess for a four-week work period that runs through June. Both chambers then break for one week for Independence Day. After that, the House is scheduled to...more

Health Alert (Australia) - June 1, 2015

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Australia. Family Court - 22 May 2015 - Re Ashley [2015] FamCA 37 The Family Court has found that a 17 year old...more

The Continuing Evolution of the French Sunshine Act

Since the general disclosure rule for provider-manufacturer relationships in France was enacted into law on January 1, 2012, its compliance and enforcement have been a common point of discussion for health care professionals,...more

Africa Update - May 2015 #3

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News - Excerpt...more

[Webinar] Mid-Sized Companies and Anti-Corruption: How to manage corruption risks with limited resources - May 28, 11:00 am EST

Instances of corruption can have a significant impact on a company’s finances and reputation. With international anti-bribery enforcement actions on the rise, it is essential for companies to implement an anti-corruption risk...more

Health Alert (Australia) - May 18, 2015

In This Issue: Judgements; Legislation; and Reports. - Excerpt from Judgments: Queensland - 8 May 2015 - Vega Vega v Hoyle [2015] QSC 111 - The Queensland Supreme Court has held that...more

Why the Health Care Industry Needs to Focus on Data-Flow Restrictions in China

U.S. health care providers, device manufacturers, lab managers, health information technology and telemedicine/telehealth project investors, and other industry members involved in projects in China, need to be aware of a long...more

Health Alert (Australia) - May 11, 2015

In This Issue: Judgments, Legislation; and Reports and Publications. Excerpt from Legislation: Commonwealth - 5 May 2015 - Australia New Zealand Food Standards Code — Standard 1.4.2 — Maximum Residue...more

Life Sciences Spotlight - Asia Pacific - Issue 5, 2015

In This Issue: - Harper Review Dispenses Important Recommendations For The Life Sciences Sector - Pharmaceutical Patent Term Extensions In Australia - PRC Anti-Corruption Regime 101 - Revisions To The Medicines...more

April Whistleblower News Digest | Consider Targeted Anti-Retaliation Training as part of Your Ethics and Compliance Training...

If April showers bring May flowers, then May is going to be a veritable hurricane of whistleblower-related fines (and also pollen). Our first three items come to us from the SEC, with awards and fines galore, most notably the...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

OIG Report: FDA Has Made Progress on Oversight/Inspections of Manufacturers of Generic Drugs

Yesterday the OIG posted a report entitled “FDA Has Made Progress on Oversight and Inspections of Manufacturers of Generic Drugs” in response to a Congressional request expressing concerns about the safety and quality of...more

Health Alert (Australia) - May 4, 2015

In This Issue: Judgments; Legislation; and Reports & Publications. Excerpt from Reports & Publications: Queensland. Office of the Health Ombudsman 24 April 2015 - Health Ombudsman releases third...more

Africa Update - April 2015 #4

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub - Saharan Africa - General Africa News -...more

Can My U.S. Company Offer Online Second Opinions in China?

This post is the sixth in Foley’s blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the Chinese telemedicine market. As U.S. companies continue...more

FDA Issues Draft Guidance Addressing Reliance on Ex-U.S. Clinical Data in Medical Device Premarket Submissions

On April 22, 2015, the U.S. Food and Drug Administration (FDA) posted draft guidance that articulates the agency’s policy for the acceptance of clinical data from trials conducted outside the United States (OUS) in support of...more

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