10 years of pharmacovigilance legislation: the perspective of a national agency

AdobeStock_303039330

In 2012, the new pharmacovigilance legislation came into force, which established a uniform standard for the safety monitoring of medicines in Europe. These new legal requirements resulted in impactful changes, including the creation of a further scientific committee at the European Medicines Agency’s (EMA), the Pharmacovigilance Risk Assessment Committee (PRAC). It also resulted in a new framework for signal management, the establishment of a periodic safety update report (PSUR) single assessment and additional requirements for risk management plans (RMPs). This article reflects upon the past 10 years’ experience, including the recent pandemic. Suggestions are made on areas where the legal framework may need to be further adapted to a changing regulatory environment.

How to read this journal article 

Thank you for visiting Regulatory Rapporteur. Journal articles are restricted to TOPRA members and registered users.

If you are a TOPRA member, or have already registered for limited free access, log in now (Option 1 below).

Not yet a member? You can either join TOPRA (Option 2 below) or register to view limited content for free (Option 3 below).

1. LOGIN

Already a TOPRA member?

Log in now using your MyTOPRA credentials, for unlimited access to all Regulatory Rapporteur journal articles, the online archive and latest industry news and podcasts.

Already registered for free content?

If you are not a TOPRA member but have already created an account to access limited free content, log in here using your registered user email and password.

Login

2. JOIN TOPRA

Interested in TOPRA membership?

Become a TOPRA member and join our global regulatory affairs community.

  • Great savings on our events and training.
  • Be part of our dynamic international community.
  • Contribute to the profession.
  • Grow your skills and knowledge.
  • Take your career to the next level.

Become a member

3. REGISTER FOR FREE

Want free access to selected content?

Register now to continue to access industry news, editorials and podcasts plus one member-only journal article each month.

  • Create your own library to save your favourite content.
Create a free account