EU

The EU has been early in conducting PV, and possesses a sound PV system which is also divided into three layers for regulation: directives, regulations, and guidelines. See the following table for the main establishment process of regulations of the EU PV system.

Table 1 Main Regulation Documents within Legal Framework of the EU PV System

EMA plays a key role in pharmaceutical product approval and supervision in the EU PV system; its responsibilities are mainly to coordinate the PV work of EU, including establishing and maintaining EudraVigilance database, establishing periodic safety update report (PSUR) repository, establishing and maintaining EMA portal website, setting the format for electronic submission of pharmaceutical product information, regularly reviewing PV activities, assessing risk management system, and cooperating with WHO, etc. Furthermore, marketing authorisation holders (MAHs) are responsible for guaranteeing the safety of pharmaceutical products throughout the life cycle, and drug regulators of member states of EU are responsible for inspecting premises, records, and PV master files of MAHs.

Currently, the basic norms for the EU PV implementation are EU Guideline on good pharmacovigilance practices (GVP) which includes 16 modules: Pharmacovigilance systems and their quality systems, Pharmacovigilance system master file, Pharmacovigilance inspections, Risk management systems, Collection, management and submission of reports of suspected adverse reactions to medicinal products, Periodic safety update report (PSUR), Post-authorisation safety studies (PASS), Signal management, Additional monitoring, Public participation in pharmacovigilance, Safety communication, Risk-minimisation measures: selection of tools and effectiveness indicators, and International cooperation, etc. The new EU PV system established through the said guideline has basically covered the entire life cycle of pharmaceutical product, and established stronger relationships between pharmaceutical product safety assessment and regulation actions.

Related:

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--U.S.

Overview of EU and U.S. PV Regulations and PV Regulation Trend after China Joined ICH--China

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