International regulatory authorities

Currently, there are a number of harmonization activities in progress. Most of these involve harmonization of data and dossier formats and tend to be paper based. Harmonization efforts on work sharing are also currently under way among international regulatory authorities. Work sharing is facilitated by common formats for data... 

Foreign literature/NOT both serious and unexpected Foreign literature/serious and unexpected U.S. Consumer/NOT both serious and unexpected U.S. consumer/serious, unexpected Foreign consumer/NOT both serious and unexpected Foreign consumer/serious, unexpected FDA, initial/serious and unexpected FDA, initial/serious and unexpected International regulatory authority/serious and unexpected International regulatory authority/NOT serious and unexpected NOT 15-day, NOT Periodic 15-day Periodic 15-day NOT 15-day, NOT Periodic 15-day 15-day Periodic, NOT 15-day 15-day NOT 15-day, NOT Periodic... 

The various national and international regulatory authorities have used different hazard classification systems in the past. In light of the importance of hazard classification, the Organisation for Economic Cooperation and Development (OECD) recently harmonized criteria for hazard classification for global use. For example, the five harmonized categories for acute oral toxicity (in mg/kg body weight) are 0-5, 5-50, 50-300, 300-2000, and 2000-5000. 

The CDER Forum for International Regulatory Authorities provides information about the U.S. drug regulatory processes in an organized and integrated manner. It will explain the role of CDER as well as the science, technology, regulations, and processes used to do our work. 

The biopharmaceutical industry is a highly regulated industry where many of the activities and tasks performed by company staff are defined by regulations and guidelines issued by international regulatory authorities. The training requirements for clinical staff of pharmaceutical companies or sponsors can be relatively well defined. 

The requirements for reporting clinical trials to international regulatory authorities are similar in intent but differ in detail. Sponsors approach preparation of NDA/BLA/MAA documentation in a modular format. Each module satisfies a specific documentation need. The modules are generally organized as follows ... 

Federal and international regulatory authorities-Department of Transportation in the United States Transport Canada in Canada... 

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