The Medicines and Healthcare products Regulatory Agency (MHRA) wants the European Commission to tighten rules over providing drug safety information.

Companies should be legally obliged to disclose information on adverse effects even if noted outside of the European Union or when used outside of marketing authorisations, the MHRA says.

It also wants clear time scales for reporting information and sanctions for failing to comply.

Health minister Dawn Primarolo promised to strengthen the law 'to make it clear to all pharmaceutical companies that they should disclose any information that would have a bearing on the protection of health'.

The call follows a four-year investigation by the MHRA into handling of information on use of Seroxat (paroxetine) in under-18s by manufacturers GlaxoSmithKline (GSK).

The drug regulators say GSK should have disclosed data from some clinical trials earlier, although government prosecutors saw no realistic prospect of a conviction.

GSK has said it acted 'properly and responsibly'.

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