Effective Pharmacovigilance System Development: EFPIA-IPVG Consensus Recommendations.

ABSTRACT: Pharmaceutical legislation provides a legal framework to ensure the safe and effective use of medicines. This framework requires national regulatory authorities (NRAs) to establish and maintain a pharmacovigilance system (PV system) stating and enforcing the regulatory commitments that key stakeholders, including marketing authorisation holders (MAHs), are required to fulfil. In recent years, national legislative bodies and NRAs across the world have issued a significant amount of legislation and guidance enforcing the obligation to perform pharmacovigilance activities. In countries where the NRA is a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), safety management requirements are generally consistent with ICH guide

SUBMITTER: Peters T 

PROVIDER: S-EPMC7813705 | biostudies-literature | 2021 Jan

REPOSITORIES: biostudies-literature