Pharma GMP News of the Week: 5-December-2021

Period: November 28, 2021 to December 04, 2021

FDA releases draft guideline: Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products Guidance for Industry

Date of news: November 29, 2021

For the purposes of this guidance, a registry is defined as an organized system that collects clinical and other data in a standardized format for a population defined by a particular disease, condition, or exposure.

This guidance provides sponsors and other stakeholders with considerations when either proposing to design a registry or using an existing registry to support regulatory decision-making about a drug’s effectiveness or safety.

Source: https://www.fda.gov/media/154449/download

MHRA updated guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF)

Date of guideline update: November 30, 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) of United Kingdom has added guidance on requesting a pharmacovigilance system master file (PSMF) number in it.
 
Source: https://www.gov.uk/guidance/guidance-on-qualified-person-responsible-for-pharmacovigilance-qppv-including-pharmacovigilance-system-master-files-psmf#history