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EMA’s New Draft Guideline On Good Pharmacogenomic Practice - Implications For Personalized Medicine

Embracing personalized medicine, the European Medicines Agency (EMA) released a draft guidance document titled Draft Guideline on Good Pharmacogenomic Practice (“Guidance”) on good pharmacogenomic practice with the stated...more

Cuba an Untapped Market for Medical Device Exports

The United States is the world’s largest medical device exporter, according to reports accounting for $45 billion of over $140 billion in global exports in 2014. This is not surprising since it also produced the largest...more

The Supreme Court - June 2016 #4

The Supreme Court of the United States issued decisions in three cases on June 16, 2016: Universal Health Services, Inc. v. United States ex rel. Escobar, No. 15-7: Yarushka Rivera, a teenage beneficiary of...more

2016 Top Export Markets for U.S. Goods

Last week the Commerce Department’s International Trade Administration (ITA) released the second installment of its Top Markets Reports. The reports–nineteen different industries are highlighted in total–do an excellent job...more

Implications of Brexit for the mining and minerals sectors

The debate surrounding Britain’s proposed exit from the EU (Brexit) has primarily focused upon its potential impact on the British economy, Britain’s international standing and its capacity for self-governance. This article...more

IREG Update - Global pandemic emergencies: the insurance industry tackles a seemingly unmanageable risk

Global pandemic emergencies: the insurance industry tackles a seemingly unmanageable risk - On May 21, 2016, the World Bank Group announced the Pandemic Emergency Financing Facility (PEF), a new global financing...more

Colombian Organizations Send Letter to CEWG Regarding Imatinib Compulsory License

In letter from three Colombian organizations to the Chairman of the World Health Organization (WHO) 2016 Consultative Expert Working Group on Research and Development: Financing and Coordination (CEWG) (posted on the...more

European General Data Protection Regulation to Apply from May 2018

In Depth - On 4 May 2016, the General Data Protection Regulation (GDPR), was published in the Official Journal of the European Union (L 119/1). It will apply from 25 May 2018, at which point it replaces the current legal...more

RECAP: Highlights from the Sixty-Ninth World Health Assembly in Geneva, May 23rd to 28th

Every year in May, the health ministers from all 194 World Health Organization (WHO) Member States meet at the WHO headquarters in Geneva to attend the World Health Assembly (WHA). As the decision-making body of WHO, the WHA...more

EU Reaches Deal on New Medical Device Regulations

The European Parliament and European Council recently jointly announced an agreement regarding new rules on medical devices and in vitro diagnostic medical devices. The process that lead to the agreement began in 2012. ...more

China Competition Authority Initiates Drug Pricing Investigation

On May 22, 2015, the National Development and Reform Commission (the NDRC) of China promulgated a notice (the Pricing Investigation Notice) announcing that it would carry out a nationwide drug pricing investigation on...more

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

As we reported in our previous alert, the Cabinet of Ministers of Ukraine has recently adopted Resolution No. 312 simplifying the registration of medicinal products marketed in the US, the EU, Switzerland, Japan, Australia or...more

EU Law Making Bodies Entered into an Agreement on the New EU Medical Devices Regulations on May 25, 2016

On May 25, 2016, the European Parliament, European Council and the European Commission agreed on new rules regarding the approval and surveillance of medical devices and in vitro diagnostics for the European market. The...more

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

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