Drugmakers whose products are authorized in the EU can expect regular, risk-based and independent audits of their pharmacovigilance systems, and they should be prepared to communicate any safety risks with regulators and health professionals, according to two new guidelines related to the 2010 pharmacovigilance law that took effect July 2.
Module IV, on pharmacovigilance system audits, details the different levels of audit planning and reporting that will be required of drugmakers and member state regulatory authorities.
Audit strategies should cover a pharmacovigilance system’s governance, risk management and internal controls. The audit itself should focus on such risk factors as:
- Whether a drug is the first on the market;
- Outcomes of previous audits;
- New legislation or regulatory guidance; and
- Whether a company’s quality system is run by trained and experienced pharmacovigilance staff.
Investigators should be independent, unbiased and able to gauge and communicate whether a system’s risks are critical, major or minor.
EU member state authorities must report results of initial pharmacovigilance system audits to the European Commission by Sept. 21, 2013, and then every two years going forward, the guideline states.
These new regulations will force myriad changes in the way you do business in Europe. New and changed definitions. New regulatory bodies. New reporting requirements. Fortunately, help is at hand with FDAnews’ EU Pharmacovigilance: 2012 Compliance Guide.
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