Drug Development Technology - A Shrinking World: Realizing Regulatory Harmony

Author:

Gillian King and Joel Finkle

The life sciences industry faces a number of tough challenges in 2012 - not the least of them the growing reach of increasingly onerous regulatory requirements.

While new international market opportunities are emerging all the time, exploiting them remains challenging because of the differing ways each region and country handle regulatory submissions. Even when submissions follow the guidance of the International Conference on Harmonization (ICH) - which indeed has brought greater cohesion to the ways such activities are managed across the three major markets of the US, the European Union (EU), and Japan - there remain differences in interpretation involving submission formats, such as the electronic Common Technical Document (eCTD). To be able to take full advantage of all of the market opportunities open to them, companies must ensure their submissions can meet the requirements of the evolving formats, the developing standards, and the old and new regulations stipulated by the respective authorities.

The following explores some of the major developments that have taken place throughout the past year in major markets and what those developments mean for the industry in the future. Read full article starting on page 18 in Drug Development & Delivery. (PDF, 5.2 MB)