FDA
FDA seeks input on botanical drug development
FDA opened a public docket requesting stakeholder perspectives on botanical drug development in the United States, including challenges and potential solutions for gathering information required under the FD&C Act.
Read the official sourceMHRA
MHRA and NICE describe real world evidence dialogue
The agencies published information on a scientific dialogue programme intended to support decision making across product lifecycles and inform regulatory and health technology assessment evaluations.
Read the official sourceMHRA
MHRA publishes International Recognition Procedure guidance
The guidance explains how to use the International Recognition Procedure for medicines licensing applications.
Read the official sourceEMA
EMA issues EudraVigilance portal user manual
EMA published version 2.2 of its user manual for online access to suspected adverse reaction information through the adrreports.eu portal.
Read the official sourceMHRA
MHRA provides medicine reclassification guidance
The guidance explains how to apply to move a medicine among pharmacy, prescription only and general sale list classifications.
Read the official sourceWhy this matters
The FDA docket offers stakeholders a formal route to describe evidence challenges in botanical drug development. In Europe, the MHRA and EMA materials provide practical references for evidence planning, licensing, medicine classification and access to adverse reaction reports.
Scott Morvay
Founder, Gulfstream Intelligence
This brief provides general regulatory news and educational information. It is not legal or regulatory advice.