The directives and regulations, which represented the biggest change to human medicine regulation in the EU since 1995, are designed to improve collection of data and provide means for rapid and robust assessment of safety issues.
For marketing authorisation holders and applicants, this results in:
- clearer roles and responsibilities;
- minimised duplication of effort;
- simplified reporting procedures;
- clarity over the legal framework for monitoring activities.
Implementation of the legislation
The pharmacovigilance legislation is accompanied by an implementing regulation, which provides operational details.
Further amendments strengthen the system, specifically by providing for prompt notification and assessment of safety issues.
The legislation created new tasks and activities for regulators and the pharmaceutical industry, which can be divided into four areas:
Collection of key information on medicines
- The legislation established or reinforced the need for and format of various reports, including:
- There are further requirements concerning data submission for authorised medicines and notification of action to withdraw a product (if the decision is taken on grounds such as the medicine being harmful).
- European citizens can report suspected side effects directly to MAHs and national regulatory authorities.
Analysis and understanding of data and information
- Signal detection and management for national and centrally authorised medicines was strengthened.
- The legislation introduced an inverted black triangle symbol, printed on the product information of medicines under additional monitoring.
Regulatory action to safeguard public health
- The Pharmacovigilance Risk Assessment Committee (PRAC) was established, while the Coordination Group for Mutual Recognition and Decentralised Procedures - Human now takes the lead on implementing safety recommendations.
- Referral procedures were enhanced to ensure emerging safety issues are quickly assessed by the PRAC.
- Monitoring of medical literature: EMA performs medical literature monitoring to screen selected medical literature, to identify suspected adverse reactions with medicines authorised in the European Union, and to enter the relevant information into the EudraVigilance database.
- Medicines under additional monitoring
- Agendas and minutes of all committee meetings are published by the Agency, and public hearings on safety issues can be arranged.
- To guarantee consistency, the Agency coordinates announcements on the safety of medicines across the EU, including nationally authorised products.
- Stakeholder meetings: EMA hosts stakeholder forums to raise awareness of the requirements of the pharmacovigilance legislation and promote the exchange of ideas, concerns and opinions and pharmacovigilance platform meetings provide an opportunity for both a general update and more focused discussions on specific processes or issues.