COMPARISON OF NEW DRUG APPROV AL PROCEDURES AND REGULATORY STRUCTURES IN TURKEY AND CANADA

A regulatory process, by which a person/organization/sponsor/innovator gets authorization to launch a drug in the market, is known as drug approval process. Every country has its own regulatory authority, which is responsible to enforce the rules and regulations and issue the guidelines to regulate the marketing of the drugs. A drug approval process comprises of various stages: application to conduct clinical trials, conducting clinical trials, application to marketing authorization of drug and post-marketing studies. The purpose of this article is to present a concise overview of the drug approval process in Turkey and Canada. Key Words: Drug approval process, clinical trials, marketing, regulatory authority, post marketing studies.