Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 69

These are reviewed elsewhere in this manual. Most of the consensus documents that have been developed have been done by international organizations, such as CIOMS and ICH. These documents represent the agreed-on consensus for best/optimal practices by governments and pharmaceutical companies and others involved in pharmaceutical research, development and sales. Many countries and governments do indeed adopt these documents as the laws or regulations in their countries. Others adopt them with changes.

The key point here is that these documents themselves do not hold the force of law and do not have to be followed unless a particular country or health agency indeed makes them into law or regulations. Thus, one must examine the PV requirements in each country or jurisdiction where one is working.