Japan’s Drug Lag and National Agenda
Eriko Tsukamoto, MBA and Satish Tripathi, PhD

Regulatory Focus (January 2011: Journal of Regulatory Affairs Professionals Society)

Since 1999, a drug called Doxil has been used in 75 countries as the standard treatment for recurrent ovarian cancer. In Japan, however, patients waited nearly 10 years before Doxil received approval and became listed in April 2009.

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Opportunities & Challenges in Latin America
Yelena Sheftelevich, J.D. , Satish C. Tripathi, Ph.D.

Developing markets have been a source of interest to pharmaceutical companies for decades and it is not a revelation that the developing markets of Latin America, in particular, have been growing in importance over the years. Indeed, the attractiveness of this region has become more and more apparent as the governments of these countries have taken great strides in developing a more robust market for the pharmaceutical industry. As the regulatory framework has evolved in this region, so too has its appeal.

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Small Latin American Countries Think Big
Policies in Chile, Peru, and Argentina Are Drawing Favorable International Attention

Feature Article: Genetic Engineering News Dec 1, 2010 (Vol. 30, No. 21)

The first article in this two-part series appeared in the June 15 issue of GEN. It examined the challenges and opportunities associated with Brazil, Mexico, and Colombia. This article picks up from where the other left off, providing insight into the unique aspects of the pharmaceutical markets in Chile, Peru, and Argentina.

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Drug Registration in Russia and the New Law
Yelena Sheftelevich, J.D. , Satish C. Tripathi, Ph.D.

Regulatory Focus (September 2010: Journal of Regulatory Affairs Professionals Society) 15:36-44

On 13 April 2010, after much controversy and critique, the Russian government enacted a far reaching piece of new legislation to regulate the pharmaceutical industry. This new law went in to effect on 1 September 2010, and although its exact implications cannot be known with certainty, it is clear that the regulatory landscape in Russia will be fundamentally changed. Read more:

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