International


FDLI's International News items are provided by RegLink News, which tracks regulatory, policy and health technology assessment developments around the world. FDLI Members can enjoy a 30-day free trial and receive a 15% discount on subscriptions to RegLink’s weekly Global Updates.



International News

Certification of Needles and Syringes Takes Effect

July 2013

Brazil’s National Agency for Sanitary Surveillance (Anvisa) confirmed that as of July 1 maufacturers of needles and syringes must f...

Manual of Brazilian Nonproprietary Names Launched

June 2013

Brazil’s National Agency for Sanitary Surveillance (Anvisa) launched on June 26 the country’s first Manual of Brazilian Nonpr...

China Implements Revised Good Quality Control Standards for Drugs

June 2013

The China FDA has issued a Notice that as of July 1, 2013, new start-up pharmaceutical enterprises, as well as pharmaceutical enterprises...

Anvisa Launches Best Practices for Device Industry

June 2013

Brazil’s National Agency for Sanitary Surveillance (Anvisa) launched the Guide on Assistance in the Implementation of Best Practice...

Chinese Provinces Get Class III Device and IVD Inspection and Approval Authority

June 2013

In order to implement the "State Council institutional reform and functional transformation plan" designed to further deepen the reform o...

Books & Primers

Food Law and Regulation, Inspection and Enforcement – an FDLI Primer

June 2015

By Marc C. Sanchez, Contract In-House Counsel and Consultants, LLC This resource offers an overview of the regulation of food from the p...

Brazilian Drug and Medical Device Regulation: A Practical Guide

January 2013

The Food and Drug Law Institute (FDLI) is pleased to provide Brazilian Drug and Medical Device Regulation: A Practical Guide as a compa...

International Prescription Product Recalls - A Practical Guide

March 2010

About This Monograph Prior to 2012, FDLI published the FDLI Monograph Series, which consisted of six monographs annually. We no...

Articles

Members Only Content2016 Annual Conference: Top Food and Drug Cases, 2015 & Cases to Watch, 2016

May 2016

As in years past, one of the most popular sessions at FDLI’s Annual Conference brought law professors and practitioners together to...

Members Only Content2016 Annual Conference: Honorable Royce C. Lamberth Video

May 2016

At FDLI’s recent 2016 Annual Conference, The Honorable Royce C. Lamberth, offered candid insight into the Vascular Solutions case....

2016 Annual Conference: FDA Commissioner Robert M. Califf's remarks

May 2016

“…there are few events that encompass such a longstanding tradition and offer as important and meaningful an opportunity to ...

Update Magazine March / April 2016

March 2016

Contents Letter Letter from the President & CEO Features Managing the Risks Embedded in Embedded Marketing: Five Things Every Manuf...

FOOD & DRUG LAW JOURNAL

Food and Drug Law Journal Volume 70, Issue 4 2015

February 2016

To purchase articles, go to https://shop.heinonline.org/.   Table of Contents i Rep...

A Legislative Reform for the Food Safety System of China: A Regulatory Paradigm Shift and Collaborative Governance 70 FOOD AND DRUG LAW JOURNAL 453-480 (2015)

December 2015

After describing the historical development of China’s food safety system from the perspectives of legislation and administration, ...

Most Serious Offenses and Penalties Concerning Unsafe Foods under the Food Safety Laws in Bangladesh, India, and Australia: A Critical Analysis 70 FOOD AND DRUG LAW JOURNAL 409-433 (2015)

December 2015

The right to food is an internationally recognized human right, which inherently denotes the right to safe food simply because unsafe foo...