Some Interesting Foreign Drug Regulatory Features

Abstract

The process involved in the registration and sales of drug products abroad are not a simple matter. While there are some efforts toward standardization through the Nordic Council, the European Community and via the World Health Organization, the activities required, sequence, procedures, etc. vary greatly around the world. Moreover, it is a jungle of rules of varying rationale in doing business internationally. Some countries require local clinical trials, others do not; some others require extensive toxicity testing while others do not. Then one is faced with requests for price information, cost data, requests for bribes, rules about patents, patent licensing, domestic joint venture requirements and others.

The article presents an abbreviated road map of some of these most common obstacles that should be considered by persons working in this area with an interest in developing an international presence.