Regulators demand drug transparency
17 Mar 08
Source: Healthcare Republic
The DoH has promised to act after UK drug regulators called for tougher legislation on disclosure of adverse effects by drug manufacturers.
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'.