Health International Trade

Read need-to-know updates, commentary, and analysis on Health issues written by leading professionals.
News & Analysis as of

USA vs. Europe: Patients Hang in Balance as Big Pharma Reports Drug Side Effects Differently to FDA, EMA

A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug...more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

Ukraine simplifies the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or Canada...

On 20 April 2016 the Cabinet of Ministers of Ukraine adopted Resolution No. 312 amending the Procedure for State Registration (Registration Renewal) of Medicinal Products (the Procedure.) The changes took effect on May 13....more

On May 4, 2016 changes to the procedure for applying the “third one is out” rule in state procurement of medical devices entered...

RF Government Resolution No. 102 of February 5, 2015 approved a list of certain types of foreign-manufactured medical devices (the “List” and “Devices,” respectively) in the procurement of which state and municipal customers...more

Changes in the regulatory control of the pharmaceutical market - Q1 2016 Review

Until January 1, 2017, for confirming the state registration of a foreign medicinal product, it is permitted to present a certificate of GMP ?ompliance (obtained in the country of origin) to the applicable GMP standards in...more

The Digital Download - Alston & Bird’s Privacy & Data Security Newsletter – May 2016

Special Focus on “Safe Harbor 2.0,” Privacy Shield and E.U. Data Transfers: Alston & Bird’s privacy team has been closely following the development of Privacy Shield, the proposed successor to the E.U.-U.S. Safe Harbor...more

Tobacco Cases Expose Tension Between Antitrust and Public Health

A recent decision of the European Court of Justice (“ECJ”) regarding the sale of tobacco products highlights a long-standing tension between two sets of laws: antitrust/competition laws, which seek to keep products affordable...more

Veterans Affairs to Permit Acquisition of Non-TAA-Compliant Drugs

In a significant policy reversal, the Department of Veterans Affairs (VA) has announced that it will require all covered drugs under the Veterans Health Care Act (VHCA) to be offered on Federal Supply Schedule (FSS)...more

Top Takeaways from IAPP

The world of privacy grows every day as more data goes through the cloud. The new trends and weekly data breaches make conferences like the Global Privacy Summit all the more relevant. Earlier this month we went to...more

FCPA compliance and Ethics Report-Episode 249-Reflections on Cuba, with Adam Turteltaub [Video]

In this episode, I share some reflections and observations on Cuba with Adam Turteltaub who was coincidently on a tour in Cuba at the same time as myself. ...more

Public Health Organizations Urge Congress to Reject Trans-Pacific Partnership Agreement

In a letter sent to members of Congress earlier this month, 58 public health organizations urged Congress to reject the Trans-Pacific Partnership (TPP) in its current form, stating that the coalition was "alarmed by the...more

U.S. Market Entry for the German Healthcare IT Company

The healthcare market in the United States is massive, with total spending in excess of $3 trillion. Federal government incentives for the adoption of electronic health records has resulted in an increasingly interoperable...more

DHS Warns of New Ransomware Threats

The Department of Homeland Security (“DHS”) recently issued a joint alert with the Canadian Cyber Incident Response Centre warning of two new ransomware threats behind recent well-publicized attacks against healthcare...more

China Issues First Update to Medical Device Clinical Trial Guidelines in 12 Years

The Chinese Food and Drug Administration (“CFDA”) recently announced its first update to the medical device clinical trial guidelines in 12 years. The finalized revision to the 2004 Medical Device Clinical Studies Rules...more

Your daily dose of financial news The Brief – 4.11.16

The UK’s Daily Mail is reportedly joining Verizon in the field of suitors for Yahoo’s assets – WSJ - It’s no surprise when mega mergers attract the government’s attention, as we’ve seen in past weeks around here. But...more

Indiana Medical Device Manufacturer’s Deferred Prosecution Agreement with DOJ Extended for a Second Time

On March 25, an Indiana-based medical device manufacturer announced that the deferred prosecution agreement it entered into with the DOJ to settle FCPA charges in 2012 would be extended a second time. The company reported...more

Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On March 23, the SEC announced that it settled FCPA allegations with a Switzerland-based pharmaceutical company, via a cease and desist order finding that the company violated the FCPA’s book and records and internal controls...more

Novartis Agrees to Settle Bribery Charges Against Chinese Subsidiaries for $25 Million

On March 23, 2015, Swiss-based pharmaceutical company Novartis AG (“Novartis”) reached a civil settlement with the United States Securities and Exchange Commission (“SEC”) for violating the internal controls and books and...more

Africa Update - March 2016 #4

Leading the News - Libya - On March 28th, Libya’s United Nations (U.N.)-backed unity government accused authorities in Tripoli of closing down the capital’s airspace to prevent it from travelling to Libya from...more

Africa Update - March 2016 #3

Leading the News - Republic of Congo - On March 20th, the Republic of Congo (ROC) held voting in a presidential election that was predicted to see President Denis Sassou Nguesso extend his three-decade rule....more

Novartis FCPA Enforcement Action, Part II

Yesterday, I used a quotation from the Oscar winning animator, Chuck Jones who described two of his well-known creations, Roadrunner and Wily E. Coyote, by referring to philosopher George Santayana’s description of fanaticism...more

Novartis Coughs Up $25 Million to SEC for China FCPA Violations

Last week, the SEC announced another FCPA settlement involving the pharmaceutical industry for bribery in China. The SEC’s settlement filing represents yet another example of the pharmaceutical industry run amok in China,...more

Novartis FCPA Enforcement Action, Part I

The philosopher George Santayana is usually best remembered for the pithy saying, ‘Those who cannot remember the past are condemned to repeat it.” Santayana was an essayist, poet, professor and novelist. According to...more

Foreign Corrupt Practices Act Alert

Busy Q1 Yields Several Significant FCPA Resolutions - Overview - On February 19, during the US Securities and Exchange Commission’s (SEC) annual “SEC Speaks” conference, Kara Brockmeyer, Chief of the SEC’s FCPA...more

European Life Sciences Review: Issue 2

Welcome to the second issue of our EU life sciences alerter that covers some of the most critical developments in the pharmaceutical and medical technology sectors in the last month and is produced by our life sciences...more

510 Results
|
View per page
Page: of 21

Follow Health Updates on:

JD Supra Readers' Choice 2016 Awards

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.
×