GlaxoSmithKline, Global Clinical Safety and Pharmacovigilance, Harlow, Essex, CM19 5AW, UK.
Pharmacoepidemiol Drug Saf. 2010 Mar;19(3):232-7. doi: 10.1002/pds.1898.
The responsibility for monitoring the safety of marketed medicines is shared between regulatory authorities and the pharmaceutical industry and is underpinned by legal obligations on both sides. Both marketing authorisation holders (MAHs) and regulators initially evaluate and investigate potential safety concerns, and then work together on further review as appropriate. We wanted to test the feasibility of enhanced interaction between MAH and regulator via a regular monthly, two-way communication of potential safety concerns between the MAHs and the Medicines and Healthcare Products Regulatory Agency (MHRA). It was envisaged that such a process would aid prioritisation and planning by both parties, avoid duplication of effort and support a collaborative approach for decision making.
Four MAHs took part in the pilot, which was conducted between July 2007 and June 2008. Potential safety concerns were exchanged on a monthly basis. The MAH/MHRA proposed a timeline for evaluation of each potential safety concern. The pilot did not include serious public health issues which are immediately reported to regulatory authorities.
During the pilot, 136 potential safety concerns were exchanged. Thirteen per cent of these resulted in a change to product information for health professionals and patients. There was concurrence between the MAHs and MHRA on timelines proposed for evaluation.
The pilot proved feasible for the companies involved and indicated potential benefits of a system for avoiding duplication of effort and supporting a collaborative approach to planning and prioritisation of investigation of potential safety concerns between pharmaceutical industry and regulatory authorities.
上市药品的安全性监测责任由监管机构和制药行业共同承担，并以双方的法律义务为基础。药品上市许可持有人（MAH）和监管机构最初都对潜在的安全问题进行评估和调查，然后根据需要共同进行进一步的审查。我们希望通过 MAH 和监管机构之间定期每月进行潜在安全问题的双向沟通，来测试加强 MAH 和监管机构之间互动的可行性。设想这样的过程将有助于双方的优先排序和规划，避免重复工作，并支持协作决策方法。
四家 MAH 参与了该试点，该试点于 2007 年 7 月至 2008 年 6 月进行。每月交换潜在安全问题。MAH/MHRA 提出了评估每个潜在安全问题的时间表。该试点不包括严重的公共卫生问题，这些问题会立即报告给监管机构。
在试点期间，共交换了 136 个潜在安全问题。其中 13%导致了对专业医务人员和患者的产品信息的更改。MAH 和 MHRA 在评估时间表上达成了一致。
该试点对参与的公司来说是可行的，并表明了一种避免重复工作、支持协作方法的系统的潜在好处，以规划和优先考虑制药行业和监管机构之间潜在安全问题的调查。
