2024-03-26-世界卫生组织-ACSoMP_Terms_of_Reference_5页_96kb

Advisory Committee on Safety of Medicinal Products (ACSoMP) Summary

Core Content

The Advisory Committee on Safety of Medicinal Products (ACSoMP) is an advisory body established by the World Health Organization (WHO) to provide expert guidance on pharmacovigilance policy and issues related to the safety and effectiveness of medicinal products. Its primary role is to support WHO in developing and implementing pharmacovigilance strategies, particularly in low- and middle-income countries (LMICs) and regions with underdeveloped pharmacovigilance systems.

Main Functions

The ACSoMP has three main functions:

1. Pharmacovigilance Systems

   • Advise on the introduction and integration of safety monitoring systems within WHO programmes.
   • Provide guidance on advancing vigilance systems using appropriate tools, mechanisms, and platforms.
   • Develop metrics and methodologies for evaluating pharmacovigilance system performance.
   • Formulate and share recommendations to WHO for policies related to vigilance functions, especially for LMICs and countries with low maturity PV systems.

2. Pharmacovigilance Methods

   • Guide on innovations and novel methods for collecting and interpreting safety data.
   • Promote and apply pharmacoepidemiology principles in risk assessment of medicines.
   • Advise on risk minimization and risk communication strategies, including their implementation and impact assessment in countries.

3. Safety of Medicines

   • Review the latest scientific knowledge on medicines, including WHO prequalified and recommended medicines.
   • Advise on responding to current and potential safety issues relevant to national and international health programmes (e.g., HIV, malaria, TB).
   • Monitor, evaluate, and develop risk minimization and communication strategies for priority medicines.
   • Guide safety monitoring in special populations such as pregnant women and children.
   • Support training and capacity building in pharmacovigilance in countries introducing priority medicines.

Composition

• The ACSoMP consists of up to 20 members, appointed in their personal capacities.
• Members are selected based on technical expertise, geographical representation, and gender balance.
• The Chairperson is chosen with consideration to gender and geographical diversity.
• Members serve for 3 years and may be reappointed, but the Chairperson is limited to one term.
• The Chairperson is responsible for chairing meetings and liaising with the WHO Secretariat.
• Members must not accept instructions from external authorities and must avoid conflicts of interest.
• All members must complete a declaration of interests form and sign confidentiality agreements before being appointed.
• Travel costs and per diem for in-person meetings are covered by WHO, while other work-related expenses are not.

Operation

• The ACSoMP meets at least twice a year, either in person or virtually.
• Meetings may be held in open or closed sessions.
  • Open sessions are for non-confidential discussions and may include observers.
  • Closed sessions are for confidential deliberations and recommendations.
• Quorum is set at two-thirds of the members.
• Observers may be invited by WHO to attend open sessions. They are required to complete confidentiality undertakings and declaration of interests forms.
• The ACSoMP may form smaller working groups for specific tasks, which operate via teleconference or videoconference.
• Members are expected to attend meetings regularly; missing two consecutive meetings may result in termination of their appointment.
• All recommendations are advisory to WHO, which retains full authority over final decisions.
• Recommendations are made by consensus, with minority opinions recorded if consensus cannot be reached.
• Members must not represent the ACSoMP or WHO to third parties.

Secretariat

• The WHO Secretariat provides all necessary scientific, technical, administrative, and logistical support to the ACSoMP.
• It prepares the agenda, working documents, and discussion papers for each meeting.
• It also determines who may attend as observers and whether sessions are open or closed.

Information and Documentation

• All information and documents provided to members are confidential and proprietary to WHO or its partners.
• Members and observers must not quote, circulate, or use ACSoMP documents for any purpose other than those specified in the Terms of Reference.
• Publication of ACSoMP reports is under WHO's full control.
• Members must refer any inquiries from non-WHO sources to WHO for official statements.