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Pharmacovigilance in Europe: Place of the Pharmacovigilance Risk Assessment Committee (PRAC) in organisation and decisional processes
- Source :
- Therapie. 71(2)
- Publication Year :
- 2015
-
Abstract
- The new European legislation that came into force in July 2012 reinforced the organisation of pharmacovigilance by setting up a committee in charge of risk assessment for medicines, the Pharmacovigilance Risk Assessment Committee (PRAC). The PRAC has a remit covering the assessment of all aspects of the safety and the risk management of medicinal products for human use in the European Union. It deals with issues regarding pharmacovigilance signals, the periodic evaluation of benefit/risk reports from marketing authorization holders (MAH), risk management plans, post-marketing studies, variations or renewals of marketing authorisations, management of under surveillance drugs lists, inspections for pharmacovigilance reasons and audits of pharmacovigilance systems. The PRAC works with the pharmacovigilance systems of the European Member States, which draw up evaluation reports. These evaluations are circulated and discussed by Member States so as to issue recommendations, which serve as a basis for other European medicines committees, the Committee for Medicinal Products for Human Use (CHMP) or the Coordination Group for Mutual Recognition and Decentralised Procedures-Human (CMDh) which then give their opinion. The final decision, which applies to all Member States and to the concerned MAH, lies with the European Commission (EC). This decisional procedure thus rests on coordination involving the PRAC, the CHMP, the CMDh, the EC, the Member States and the pharmaceutical companies. In the 3 years from July 2012, the PRAC has processed nearly 4500 procedures and is still facing an increasing workload.
- Subjects :
- Drug-Related Side Effects and Adverse Reactions
Legislation
Audit
Marketing authorization
030226 pharmacology & pharmacy
Risk Assessment
03 medical and health sciences
Pharmacovigilance
0302 clinical medicine
Medicine
media_common.cataloged_instance
Adverse Drug Reaction Reporting Systems
Humans
Pharmacology (medical)
European Union
European union
Risk management
Decision Making, Organizational
media_common
Risk Management
business.industry
Workload
Public relations
Legislation, Drug
Europe
business
Risk assessment
030217 neurology & neurosurgery
Subjects
Details
- Language :
- French
- ISSN :
- 00405957
- Volume :
- 71
- Issue :
- 2
- Database :
- OpenAIRE
- Journal :
- Therapie
- Accession number :
- edsair.doi.dedup.....051a6f8ccbf89a27f4843c6c9fc8a5eb