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Health Alert (Australia) - July 28, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: New South Wales (NSW) - 22 July 2014 - Lane v Northern NSW Local Health District (No 3) [2014] NSWCA 233 - This...more

Health Alert (Australia) - July 14, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Commonwealth - 4 July 2014 - Angelos v Minister for Health [2014] FCA 706 - This was an application made to the...more

China’s National Auditing Office Notes Compliance Concerns with Sponsorship of Academic Conferences in the Healthcare Sector

In China, it is common industry practice for pharmaceutical companies to sponsor academic conferences. As long as such events are aimed at enhancing the practice of medicine and patient welfare, the practice has been allowed....more

Snapshot of Sunshine Rules in EU Countries for The Pharmaceutical Industry

Since the enactment of the Physician Payments Sunshine Act (US Sunshine Act) by the United States, a number of EU Member States have adopted similar rules or strengthened pre-existing regulation in order to improve the...more

Singapore: Opportunities for Medical Innovation

In addition to mobile health opportunities in the United States, tremendous potential for growth exists throughout the world, including in Southeast Asia. Singapore in particular is working to become a leader in healthcare...more

Health Alert (Australia) - June 23, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Queensland. Department of Health: - 18 June 2014 - Public patients get private sector boost. Thousands of public patients...more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

Health Alert (Australia) - June 10, 2014

In This Issue: Judgments, Legislation and Reports. Excerpt from Reports: Queensland. Department of Health - 3 June 2014 - Strong plan delivers improving health services. The Health budget for...more

New Clinical Trial Rules in the EU: A First Overview

Last week, Regulation (EU) No 536/2014 on clinical trials on medicinal products for human use was published in the Official Journal of the European Union. The Regulation establishes a single, EU-wide harmonised set of rules...more

Significant Revisions to China’s Regulations on the Supervision and Administration of Medical Devices (State Council Order No....

China’s State Council released its new Administrative Regulation on the Supervision and Administration of Medical Devices March 7, 2014, which will be effective June 1, 2014 (the “New Regulation”). The State Council...more

Health Alert (Australia): Week of May 30, 2014

In This Issue: Judgments; Legislation; and, Reports. Excerpt from JUDGMENTS: New South Wales (NSW) - 21 May 2014 - Neville v Lam (No 3) [2014] NSWSC 607 - The practitioner is a gynaecologist...more

FDA Targets Medical Device Companies

FDA Developing New Risk and Benefit Perception Scale - Since 2008, the U.S. Food and Drug Administration has increased its presence and tightened its control over medical device companies, and this trend is expected to...more

Health Alert (Australia) - May 19, 2014

In This Issue: Judgments, Legislation, and Reports. - Excerpt from Judgments: Commonwealth - 13 May 2014 - Sklavos v Australasian College of Dermatologists [2014] FCA 476 - This was a Federal...more

IARC Advisory Group Recommends Multi-Walled Carbon Nanotubes as High Priority

An International Agency for Research on Cancer (IARC) Advisory Group met on April 7-9, 2014, to recommend priorities for IARC Monographs during 2015-2019. The Advisory Group assessed the responses to a call for nominations...more

Health Alert (Australia) - May 12, 2014

In This Issue: Judgments; Legislation; and Reports. JUDGMENTS - New South Wales (NSW)- 6 May 2014 - Health Care Complaints Commission v Khalsa (No 2) [2014] NSWCATOD 47 - This was an application...more

What are anonymous data?

Problems relating to what data/images/information can be consider anonymous is one of the major data protection issues of privacy law having an impact in any sector including the Internet of Things, eHealth and on any...more

Health Alert (Australia) - May 5, 2014

In This Issue: Judgments; Legislation; and Reports: Excerpt from JUDGMENTS- New South Wales - 2 May 2014 - Health Care Complaints Commission v Qasim [2014] NSWCATOD 42 - This was a...more

China Amends Regulations on Supervision and Management of Medical Devices; Prior Marketing Approval Requirement to Import Medical...

On March 31, 2014, China Premier Mr.Li Kequiang signed Decree No. 650 on the amended Regulations on Supervision and Management of Medical Devices (“the amended regulations”), which update the original regulations1 released in...more

Legal and Ethical Risks of Healthcare Businesses in China

Recent disputes and controversies involving Chinese subsidiaries of foreign pharmaceutical companies have sounded warning bells on legal and ethical issues regarding participation in China’s rapidly growing and evolving...more

Changes of the Amended Regulations on Supervision and Administration of Medical Devices

The Regulations on Supervision and Administration of Medical Devices was amended and promulgated by the State Council on March 7th, 2014, effective June 1st, 2014. The last version is from 2000. The following highlights the...more

Overview of Primary Provisions of U.S. and French Sunshine Reporting Requirements

2013 was a year of unprecedented scrutiny of financial relationships between manufacturers and health care professionals, such as physicians. Both the United States and France imposed sweeping new reporting and disclosure...more

Global Food, Drugs, Medical Devices and Cosmetics Newsletter

Welcome - We are pleased to provide you with the Spring edition of the Global Food, Drugs, Medical Devices and Cosmetics newsletter. As stated in our inaugural issue, this newsletter provides updates on important...more

One Step Away: European Parliament Approves New Clinical Trials Regulation

On April 2, 2014, the European Parliament approved the new clinical trials regulation (the “Regulation”) for the European Union (“EU”), with 594 votes in favor, 17 opposed and 13 abstentions. The European Parliament approved...more

China Cracking Down On Pharmaceutical Corruption

Stricter Blacklist Regime - On December 25, 2013, the National Health and Family Planning Commission of China (“National Health Commission”, former Ministry of Health) issued the amended Provisions Regarding the...more

The Elevator Speech Overview

The House and Senate were both on recess this week. On Tuesday, the U.S. suspended the operations of Syria’s U.S. embassy and consulates as the Syrian civil war enters its fourth year. Also Tuesday, details of an NSA...more

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