The new article describes in detail the key aspects related to the Pharmacovigilance Risk Assessment Expert Committee (PRAEC).
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The Drug Regulatory Authority of Pakistan (DRAP), a country’s agency in the sphere of healthcare products, has published a new revision of the guidelines on the national pharmacovigilance system. The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved in order to ensure compliance.
At the same time, the authority reserves the right to make changes to the document, should such changes be reasonably necessary to reflect corresponding amendments to the underlying legislation.
Establishment and Notification
The Pharmacovigilance Risk Assessment Expert Committee (PRAEC) is an expert advisory body notified by the Drug Regulatory Authority of Pakistan (DRAP) under Sub-rule (1) of Rule 9 of the Pharmacovigilance Rules, 2022. This notification, issued through F. No. 9-25/2019-DD (PS), dated June 10, 2022, outlines PRAEC’s role in supporting the National Pharmacovigilance Centre (NPC) in managing pharmacovigilance activities across Pakistan.
PRAEC operates at the national level, advising the NPC on key areas of risk management associated with therapeutic goods. This includes signal detection, signal management, risk minimization, and risk communication. The ultimate goal is to detect risks associated with therapeutic goods at the earliest opportunity, enabling timely recommendations for regulatory action through DRAP’s Boards or Committees.
Composition of PRAEC
As per Sub-rule (3) of Rule 9 of the Pharmacovigilance Rules, 2022, the committee is composed of experts from diverse fields.
The members and roles are as follows:
- Chairman – Appointed by DRAP from within PRAEC members.
- Co-Chair (Ex-Officio) – Director of the Division of Pharmacy Services.
- Secretary (Ex-Officio) – Additional Director or Deputy Director, Division of Pharmacy Services or Pharmacovigilance, nominated by the Authority.
- Professor of Pharmacy Practice – Nominated by DRAP.
- Expert in Basic Pharmacology – With at least 10 years of experience, nominated by DRAP.
- Expert in Clinical Pharmacology – With at least 10 years of experience, nominated by DRAP.
- Expert in Clinical Pharmacy or Clinical Pharmacist – With at least 10 years of hospital experience, nominated by DRAP.
- Expert in Medicine or Medical Specialist – With at least 10 years of hospital experience, nominated by DRAP.
- Expert in Epidemiology or Pharmacoepidemiology – With at least 10 years of experience, nominated by DRAP.
- Expert in Toxicology or Forensic Medicine – With at least 10 years of experience, nominated by DRAP.
- Expert in Pharmacovigilance – With at least 10 years of experience in pharmacovigilance activities, nominated by DRAP.
- Expert in Clinical Trials or Drug Research – With at least 10 years of experience, nominated by DRAP.
- Expert in Biologicals – With at least 10 years of experience, nominated by DRAP.
- Expert in Biostatistics – With at least 10 years of experience, nominated by DRAP.
Functions of PRAEC
Under Rule 10 of the Pharmacovigilance Rules, 2022, PRAEC has the following responsibilities:
- Advisory Role in Risk Management
Provide advice to NPC-DRAP on all aspects of risk management associated with the use of therapeutic goods, including:
- Signal detection and prioritization.
- Risk minimization strategies.
- Risk communication concerning adverse drug reactions.
- Signal Detection and Management
PRAEC plays a pivotal role in:
- Supporting NPC in prioritizing signals.
- Conducting further signal assessment.
- Offering recommendations related to the signal management process.
- Assessment of Pharmacovigilance Reports
PRAEC reviews and provides recommendations on:
- Periodic Benefit-Risk Evaluation Reports (PBRERs).
- Risk Management Plans (RMPs).
- Post-Authorization Safety Studies (PASS).
Additionally, the committee may appoint a rapporteur for detailed analysis.
- Regulatory Recommendations
Based on assessed pharmacovigilance data, PRAEC advises NPC-DRAP to recommend necessary regulatory or remedial actions to relevant Boards, Committees, or Divisions.
- Safety Studies
PRAEC advises NPC on the imposition of:
- PASS (Post-Authorization Safety Studies).
- PAES (Post-Authorization Efficacy Studies).
These studies may be required of registration holders in response to identified safety concerns.
- Reliance Case Safety Reports
PRAEC provides expert advisory recommendations on safety reports of reliance cases. NPC reviews safety reports and alerts published by reference regulatory authorities and submits recommendations for their implementation in Pakistan.
Conclusion
In summary, PRAEC serves as a cornerstone in Pakistan’s pharmacovigilance system, combining expertise across multiple disciplines to ensure the safety of therapeutic goods. As explained by the authority, PRAEC strengthens the national pharmacovigilance framework, ultimately safeguarding public health by advising the NPC and facilitating timely regulatory actions.
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