Medicines

This branch covers regulatory writing for human medicines. It divides the work by regulatory purpose: the shared framework, clinical trials, marketing authorisation, pharmacovigilance, transparency and document management. Device regulation, product classification, veterinary medicines and the development science behind the documents belong to neighbouring branches and topics.

• The regulatory framework — the development document set, governing guidance, regional requirements, the EU regulatory network and US drug legislation
• Clinical trials — trial ethics, quality standards, applications, protocols, operational records and reporting
• Marketing authorisation — applications and procedures, dossier documents, exchanges with agencies and product classes with distinct requirements
• Safety and pharmacovigilance — the discipline and legal framework, case processing, signals, aggregate reports, risk management, safety studies and the system master file
• Transparency and disclosure — disclosure’s purpose and development, document preparation, registries, EU trial disclosure, regulators’ publication programmes and data sharing
• Managing regulatory documents — responsibilities, planning, coordination, authoring, quality, systems, submission leadership and post-approval work