L’EMA a publié le plan de travail de son Comité pour l’évaluation des risques en pharmacovigilance (PRAC), pour l’année 2021.


Activités concernant les médicaments à usage humain

Activités Pré-AMM  Objectifs 2021
Population particulière et guides produits   

Grossesse et allaitement


Finalisation of GVP P. III on ‘Product or populationspecific considerations: pregnancy and breastfeeding’ postpublic consultation.

Evaluation des risques et collecte d’informations   

Révision des Bonnes pratiques de Pharmacovigilance 


  • Initiate the public consultation of revision 3 of GVP module XVI on ‘Risk minimisation measures: selection of tools and effectiveness indicators’ with addendum II on ‘Risk minimisation measures effectiveness evaluation
  • Finalise revision 3 of GVP module XVI and addendum II postpublic consultation, subject to COVIDrelated work as a priority.
  • Finalise GVP module XVI addendum III on ‘Pregnancy prevention programme’ in view of initiating a public consultation.


Evaluation des plans de gestion des risques 


  • Contribute to further optimise close cooperation with CHMP and CAT as regards RMP assessments,including RMPs for generic medicinal products and RMP requirements for ATMPs.


Suivi des effets indésirables spécifiques : utilité des questionnaires 


  • Consolidate the review on the use and utility of specific adverse reaction followup questionnaires as a routine pharmacovigilance activity.
Activités post-AMM   Objectifs 2021
 Informations résultants des données en vie réelle 

Le PRAC précise « Data and information from the realworld use of medicines is a key enabler for access to new treatments and will support the PRIME scheme and Adaptive Pathway initiatives »


Registres patients – Analyse des données 


  • Provide expert input in the implementation of the recommendations from the HMA/EMA Big Data Steering Group.


  • Provide expert input to the EMA initiative on patient registries and the crossCommittee task force on registries on the development of guidance on methodological aspects and governance of patient registries: input in the review of the guideline on registrybased studies post public consultation.


  • Review of experience gained within the pilot of rapid data analysis: build a checklist based on the experience from actual cases with possible and nonpossible data analyses, summarising experience and feedback obtained (including feedback from questionnaire).
Activités de Pharmacovigilance Objectifs 2021
Détection et gestion des signaux 



Améliorer la gestion des signaux 


Provide expert input in improving methods and outputs including data analytics and retrieval to ensure continuous improvement of signal management, including piloting the algorithm for detecting unexpected increases in frequency of ADR reporting, and machine learning based on EudraVigilance data. This includes methodologies for COVID19 safety monitoring and input in methodologies to be used during the vaccination campaign.

Mesurer l’impact des activités de Pharmacovigilance   

Impact des interventions règlementaires 


  • Provide expert input and scientific guidance for industry and regulators on impact research objectives and methodologies, including training to assessors (related to GVP module XVI, see  under 1.1.2. ).
  • Oversee and advise on the conduct of impact research of pharmacovigilance regulatory interventions, including prioritisation of research topics.
  • Enhance engagement of patients and HCPs in measuring the impact of regulatory interventions 

En ce qui concerne les activités transversales : deux grands objectifs sont fixés pour 2021