Northerner
Admin (Retired)
- Relationship to Diabetes
- Type 1
Arrangements need to be put in place to ensure that the National Institute for Health and Care Excellence (NICE) can access all the evidence underlying product licensing decisions taken by the Medicines and Healthcare products Regulatory Agency (MHRA) and the European Medicines Agency (EMA), says the National Audit Office (NAO).
Because NICE has no automatic access rights to manufacturer information submitted to either EMA or the MHRA, the Institute?s legal position is not as strong as the regulators, and this leads to duplication of effort by NICE and also the possibility of gaps in the evidence available to it, says the NAO, in a memorandum sent to the House of Commons Committee of Public Accounts (CPA).
http://www.pharmatimes.com/Article/..._for_pharma_licensing_decisions_says_NAO.aspx
Because NICE has no automatic access rights to manufacturer information submitted to either EMA or the MHRA, the Institute?s legal position is not as strong as the regulators, and this leads to duplication of effort by NICE and also the possibility of gaps in the evidence available to it, says the NAO, in a memorandum sent to the House of Commons Committee of Public Accounts (CPA).
http://www.pharmatimes.com/Article/..._for_pharma_licensing_decisions_says_NAO.aspx