The regulatory framework

This branch covers the framework shared by regulatory documents for medicines, divided into the development document set, governing guidance, regional differences, the EU regulatory network and the making of US drug legislation. Requirements specific to individual documents, management of document consistency and device regulation sit outside this branch.

• The documents a development programme produces — documents across development and after approval, their readers and their role in the evidence for authorisation
• The guidance a regulatory document answers to — regulations, guidances, ICH families, document-specific requirements, finding updates and justified departures from guidelines
• Where national and regional requirements still diverge — national regimes, China and Japan, UK proposals, Eurasian harmonisation and US–European convergence
• The EU medicines regulatory network — legislative and strategic change, medicine shortages and cooperation with other agencies and regulators
• How US drug legislation comes about and reaches the writer — tragedy and public outrage as legislative drivers, and implementation of statutes through regulations