Safety Specification

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Chapter: Pharmacovigilance: Risk Management - a European Regulatory View

The starting point for proactive pharmacovigilance, the safety specification, summarises what is known and what is not known about the safety of the product.


The starting point for proactive pharmacovigilance, the safety specification, summarises what is known and what is not known about the safety of the product. This encompasses the important identified risks and any important information and outstanding safety questions which warrant further investigation, in order to refine understanding of benefit:risk during the post-authorisation period. The epidemiology of the indication is to be included, together with background incidence rates of events of interest for further inves-tigation. Additional EU requirements for inclusion in the safety specification are potential for overdose, potential for transmission of infectious agents and potential for misuse for illegal purposes. The safety specification also forms the basis for the risk minimi-sation plan if this is required.


The purpose of the pharmacovigilance plan is not to replace but to complement procedures in place to detect safety signals. For medicines with important identified risks, important potential risks or important missing information, additional pharmacovigilance activities to address these concerns should be consid-ered. The EMEA Guideline describes a range of study designs (e.g., active surveillance, comparative obser-vational studies) and data sources. An inventory of European pharmaco-epidemiology centres and health-care databases is to be created by EMEA to facilitate the implementation of pharmacovigilance plans.


A risk minimisation plan is only required in circum-stances where standard information provision via the medicine’s summary of product characteristics, patient information leaflet and label is not considered adequate to address identified safety concerns. Where a risk minimisation plan is considered necessary, both routine and additional activities are to be included. Some safety concerns may have more than one risk minimisation activity, each of which should be eval-uated for effectiveness.


The need for agreement of risk management plans for new medicines, and when an unexpected new hazard has been identified, has been rapidly incorporated into regulatory procedures as a matter of routine. This includes Opinions of the Committee for Human Medic-inal Products and the Coordinating Group. Around 50 risk management plans were reviewed in the first 6–9 months. The early experience has suggested a need for appropriate pharmaco-epidemiology and biostatistics expertise to be available, and this has also been co-opted into the membership of the Pharmacovigilance Work-ing Party from March 2006. There has also been discus-sion about wider public access to risk management plans. To date, this has been limited to isolated exam-ples such as the risk management plan for lumaricoxib, a  Cox  II  inhibitor  published  in  December  2005 (Medicines and Healthcare Products Regulatory Agency).

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