Читать книгу Cobert's Manual Of Drug Safety And Pharmacovigilance (Third Edition) - William Gregory - Страница 109

The Pharmacovigilance Risk Assessment Committee (PRAC) has experts from each member state; it provides its advice and recommendations to the EU network, and for many procedures these recommendations are considered by the CHMP before they become legally binding. They meet for 3–4 days each month (except August).

The PRAC was formally established in July 2012, replacing the former PV Working Party (PhVWP); it is responsible for assessing all aspects of risk management of human medicines, including the following:

The detection, assessment, minimization and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account to evaluate the benefit/risk balance;

The design and evaluation of post-authorization safety studies (PASS);

Pharmacovigilance audits/inspections.

The PRAC also advises the EMA on the development of guidelines, standards, and provides advice on operational aspects of the EU pharmacovigilance system.

The PRAC provides recommendations on questions involving pharmacovigilance and risk management systems, including the monitoring of their effectiveness, to the following:

CHMP for centrally authorized medicines and referral procedures;

CMDh for mutual recognition and decentralized procedures;

The EMA secretariat, Management Board, and European Commission, as applicable.

The PRAC’s primary duties include evaluation of potential signals arising from spontaneous reports and or PSURs/PBRERs, advising on risk and risk management (including regula-tory options) and monitoring regulatory actions. Their domain is largely in the post-approval area, but they do have authority for drugs under study.

The PRAC’s member contact information and declarations of interest are published on the EMA website. The PRAC includes independent experts from all EU member states in pharmacoepidemiology, clinical pharmacology, biologics, signal detection, risk communication, and vaccine vigilance. The Detailed Rules for PRAC procedures have been published (http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp&mid=WC0b01ac058058cb18).

A yearly PRAC work plan is published during the first quarter of the year. They issue work programs in advance of their monthly meetings and publish meeting highlights and meeting minutes which usually involve safety issues on specific drugs. The meeting highlights are posted on the EMA website the day after the meeting and the minutes are published after PRAC’s about a month later (http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/general/general_content_000537.jsp).

An analysis of the first 18 months of PRAC activities has been published and concluded positively: “Early signs, … based on process indicators such as those reported here for RMPs, ADRs, signals, PSURs and EU Pharmacovigilance Referrals, point to more systematic and proportionate risk management planning, the promotion of reporting (including from patients), greater coordination of real-time signal management, faster assessment and decision-making, and thus strengthening of the link between pharmacovigilance assessments and regulatory actions such as labelling changes to optimize safe and effective drug use.”¹