The European Medicines Agency (EMA) has released an updated procedural guidance document on the "Appointment of CHMP, CAT, and PRAC Rapporteurs and Co-Rapporteurs for the Committee for Medicinal Products for Human Use (CHMP), Committee for Advanced Therapies (CAT), and Pharmacovigilance Risk Assessment Committee (PRAC)". This guidance ensures scientific integrity, transparency, and expertise-driven assessments for medicinal product evaluations under the centralised procedure.
Rapporteurs: A rapporteur is a designated expert from a national competent authority (NCA) responsible for leading the scientific evaluation of medicinal products submitted through the centralised procedure.
Types of Rapporteurs in EMA Committees:
CHMP Rapporteur: Leads the scientific evaluation of human medicines under the centralised procedure.
CAT Rapporteur: Focuses on Advanced Therapy Medicinal Products (ATMPs), such as gene and cell therapies
PRAC Rapporteur: Assesses the safety and risk management of medicines, including pharmacovigilance referrals.
Rapporteurs are supported by co-rapporteurs to ensure a comprehensive scientific review.
Methodology for Rapporteur Selection
Rapporteurs are chosen using a structured methodology:
✔ Scientific competence and regulatory experience in the relevant therapeutic area.
✔ Ability to meet EMA assessment timelines.
✔ Availability of additional expertise from within their national agency.✔ Previous performance in marketing authorisation assessments.
✔ Workload balance among EU Member States.
If multiple candidates meet the selection criteria, the rapporteur is assigned based on equitable distribution across EU regulatory agencies.
Appointment Process for Rapporteurs & Co-Rapporteurs
A) Centralised Procedure
Rapporteurs are nominated from EMA Member States.
Selection is based on objective criteria, including previous assessment experience and workload balance.
For ATMPs, CAT members are prioritised, with CHMP co-rapporteurs supporting the evaluation.
B) Generic & Hybrid Medicines
CHMP rapporteurs are appointed for the initial evaluation and post-authorisation changes.
If multiple applications exist for generics of the same reference drug, the same rapporteur is assigned to ensure consistency.
C) Referral Procedures & Pharmacovigilance
PRAC rapporteurs assess safety referrals, including Article 20 (EU-wide safety concerns) and Article 31 (national referral procedures).
Re-examinations require new rapporteurs to ensure impartiality.
D) Post-Authorisation Safety Studies (PASS)
Rapporteurs for Post-Authorisation Safety Studies (PASS) are selected from PRAC, ensuring continuity in safety monitoring.
The EMA has specific procedures for appointing rapporteurs and co-rapporteurs for various types of applications and procedures, including:
Centralized Procedures: For initial marketing authorization applications.
Generic/Hybrid Applications: Streamlined approaches are in place.
Re-examinations: In cases where an initial opinion is re-examined.
Referral Procedures: For issues affecting multiple medicines or involving safety concerns.
Signal Management: For evaluating potential safety signals.
PSURs/PSUSAs: For periodic safety update reports and assessments.
Post-Authorization Safety Studies (PASS): For protocols and results of mandated safety studies.
The selection process considers objective criteria at both the assessment team and individual levels. These criteria ensure that the most qualified individuals are chosen to lead the evaluation. The EMA also has procedures in place for managing changes that may affect the appointment of a rapporteur or co-rapporteur during an ongoing assessment.
🔗 For full procedural details, refer to the official EMA guideline: EMA Procedural Advice on Rapporteur Appointments 📅 Adopted: February 2025 (Revision 4)
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