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

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...


Winckler to Step Down as FDLI President and CEO; Recruitment Underway

March 2014

The Food and Drug Law Institute, the premier educational organization in the field of food and drug law, announced today that President a...

The Food and Drug Law Institute To Honor Axelrad, Gibbs, Holcombe, Kingham

December 2013

Honorees Will Receive Distinguished Service and Leadership Awards at Holiday Reception December 10 December 5, Washington, DC -- The Food...

Members Only ContentDrug Development Models in China and the Impact on Multinational Pharmaceutical Companies

September 2013

China represents a huge potential opportunity for the pharmaceutical industry in both commercial and research and development spaces. In ...

Members Only ContentReform of China's Food Safety Regulatory System: Are You Ready?

August 2013

In March 2013, the annual sessions of China's National People's Congress and the Chinese People's Political Consultative Conference (refe...


Food after Fukushima – Japan's Regulatory Response to the Radioactive Contamination of its Food Chain, 67 Food and Drug Law Journal, 51-64 (2012)

March 2012

The nuclear accident in Fukushima triggered a process of regulatory action, inspections, and market restrictions that has deeply affected...

A Perspective on Emerging Law, Consumer Trust and Social Responsibility in China's Food Sector: the "Bleaching" Case Study

August 2011

Trust underpins the Chinese social system, and yet it is lacking from a Chinese food system that is riddled with safety disasters and dis...

Identifying Gaps in International Food Safety Regulation

May 2011

The rise in food importation in countries such as the United States, coupled with food safety incidents, has led to increased concern wit...