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Health Alert (Australia) - December 8, 2014

In This Issue: Judgments and Reports. Excerpt from Reports: Australia. Department of Social Services - 4 December 2014 - 2014 Aged Care Approvals Round (ACAR) results. Senator Mitch Fifield,...more

Health Alert (Australia) - November 10, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Reports: Australia. Health Practitioner Regulation Agency (AHPRA) and the boards - - 7 November 2014 - Media release AHPRA and the...more

IMDRF Releases International Framework for Regulating Device Software

On October 14, 2014, the International Medical Device Regulators Forum (IMDRF) issued a final version of “Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations” (“the...more

FDA Regulatory and Compliance Monthly Recap

Mobile health industry could get a boost as FDA draft guidance exempts certain medical devices, including digital health devices - The FDA’s decision to not require a number of mobile health devices to go through the...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

FDA Releases Unique Device Identification Final Rule, Draft Guidance

On September 24, 2013, the Food and Drug Administration (FDA) published a Final Rule, which will, over the next several years, require many medical devices distributed in the U.S. to carry a unique device identifier (UDI)....more

"Ranbaxy Resolves Criminal and Civil Charges Through Record Settlement"

Executive Summary - On May 13, 2013, generic drug manufacturer Ranbaxy USA Inc. (Ranbaxy), a subsidiary of Indian generic drug manufacturer Ranbaxy Laboratories Limited, pled guilty to seven felony charges as part of a...more

2013 Enforcement Predictions

I always like to make predictions at the beginning of each year. My track record is plus and minus – sometimes on target, sometimes off-target. The biggest story in the last five years has been the rise of FCPA...more

Corporate and Financial Weekly Digest - December 21, 2012

In this issue: - Nallengara to Replace Cross as Corp. Fin. Chief - FINRA Rule Relating to Private Placements of Securities Effective December 3 - Additional Guidance on FINRA’s Suitability Rule - No-Action...more

China Life Sciences and Health Industry Client Briefing – November 2012 (December 13, 2012)

In This Issue: Priorities, Practical Tips and Lessons Learned from Reed Smith’s China Device Regulatory Briefing on December 4, 2012; Programs of Designated Drug Production to be Initiated: Five to 10 Pilot Varieties...more

China Life Sciences and Health Industry Client Briefing – October 2012 (November 16, 2012)

In This Issue: - China Becoming Healthcare R&D Hub (China Daily 2012-10-09) – October 9, 2012 - Imported Drugs to Go on China's Electronic Monitoring Network (Xinhua News Agency 2012-10-08) – October 9, 2012...more

China Issues Human Genetic Resources Management Regulations

Those seeking to conduct research involving human genetic material within the People’s Republic of China or to import into China such material should review China’s recently issued draft regulations (“Draft”) for the...more

DOJ and SEC Issue Highly Anticipated FCPA Guidance

On November 14th, the U.S. Department of Justice (“DOJ”) and the U.S. Securities and Exchange Commission (“SEC”) published A Resource Guide to the U.S. Foreign Corrupt Practices Act, their long-awaited, highly anticipated...more

Chinese FDA Soliciting Public Comments on Rules for Re-Packaging of IVDs

The State Food and Drug Administration (“SFDA”) in China published a draft of the Tentative Measures for the Administration of the Registration of Re-Packaging In-Vitro Devices (IVDs) (“Draft Measures”) on November 2 for...more

OFAC Publishes New Iranian Transactions and Sanctions Regulations

Recently the U.S. Treasury Department Office of Foreign Assets Control (OFAC) issued new Iranian Transactions and Sanctions Regulations. Notably, the regulations formally address financing provisions for authorized sales to...more

Obama Extends Critical Immigration Programs

Critical EB-5 Regional Center, E-Verify, and Physician Conrad 30 Programs Reauthorized Until September 30, 2015 - Foreign Physicians Face New Licensure Hurdles On September 28, 2012, President Obama signed into law S....more

Under the Dome: Inside the Maine State House 9.21.12

Under the Dome: Inside the Maine State House provides a high-level overview of recent activity at the Maine State House. If you would like more specific information regarding an item in this newsletter or related to...more

‘Health Claim’ Definition to Be Interpreted Widely, EU Court Rules

In its first judgment on Regulation 1924/2006 on nutrition and health claims made on foods, the Court of Justice of the EU adopted a broad interpretation of the definition of “health claim” by ruling that claims for merely...more

French Sunshine Act: Implementing Decree to Be Published No Later than October 2012

French Law No 2011-2012 on the Strengthening of Health Protection for Medicinal and Health Products, dated 29 December 2011 (known as the French Sunshine Act), imposes new disclosure obligations to health products companies. ...more

International Employment Law Review - July 2012 / Issue 2

Welcome to the latest issue of the International Employment Law Review. In this edition, we examine the most significant employment law developments of the year thus far in Belgium, England and Wales, France, Germany,...more

Medical Device Manufacturer Resolves FCPA Violations Related to Conduct in Mexico

On July 10, medical device manufacture Orthofix International N.V. became the latest in a string of companies in the medical device sector to resolve an FCPA matter with the U.S. government....more

India's New Biosimilar Guidelines and Their Relationship to the Rest of the World

The Indian Ministries of Health & Family Welfare and Science and Technology have released their Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India (the “Indian Guidelines”). These...more

“But what is it, Doc?” – Health Care Professionals under Professionals under Regulation 1924/2006

Changes in the epidemiological profile in Western countries during the last three decades have shown an increasing trend in the development of non-transmissible chronic diseases in the adult population. Nutrition-related...more

Challenges in Ensuring Anti-Corruption Compliance by Distributors

The Justice Department’s recent enforcement action against Smith & Nephew underscored an important point – companies can be responsible for FCPA violations committed by distributors of the company’s products. FCPA compliance...more

High Noon: The Italians try to play solo the Health Claims game

On November 27, 2009, the Italian Government notified a draft regulation on the use of substances other than vitamins and minerals in food supplements before the European Commission, pursuant to the procedure laid down in...more

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