The UK Medicines and Healthcare products Regulatory Agency has achieved seven of the 12 key targets set for it by government to achieve its business objectives in 2006-7, according to its annual report.
An “unfortunate deterioration” in service for industry in product licensin
g, plus problems with some aspects of the processing of adverse drug reactions were due to the fact that the agency’s IT change programme, which ran from August 2004 to June 2006 and was accompanied by reorganisation of the medicines divisions, had a much greater impact than predicted, says the MH
RA’s chief executive, Kent Woods. However, he adds, the situation at year-end was much better than it had been in the middle of the year.
Nevertheless, these problems meant that the agency failed to realise the expected benefits for pharma of investing in the Sentinel IT system, to achieve t
he savings set out in the business case for Sentinel or to improve the service to industry stakeholders.
The introduction of the Sentinel pharmacovigilance system in May 2006 also meant the agency failed to reach its goal of identifying and transmitting suspected medical errors to the National
Patient Safety Agency within seven days, although this has been resolved and reports are now being transmitted to the NPSA within seven working days, according to the annual report.
Other targets relating to Good Practice inspections, safety warnings and consultation with stakeholders on risk
/benefit assessments were
achieved, but crucially the agency also missed its goal of developing an anti-counterfeiting strategy by the September – and this has still not been published, says the MHRA.
More success on ADR reporting, trial authorisations
During the period, t
he Agency had a 99% success rate for making reports of adverse drug reactions available for evaluation and analysis within three days of receipt in the case of fatal ADRs. For serious ADRs, the rate was 98%. Further, 99.6% success was achieved for the goal of assessing clinical trial authorisations
for Phase I trials within 21 calendar days (with an average of 14 calendar days or less), while for assessing all other trials within 30 calendar days, the rate was 99.8%.
Among the key targets outlined in the report for the agency to achieve in 2007-8 are those requiring it to:
– move to full electronic working and electronic Common Technical
Document (eCTD) standard, encourage companies to submit eCTD
applications and work with other European Union member states to
develop and implement a harmonised approach to electronic applications;
– achieve a success rate of at least 98% in completing assessment of
clinical trial authorisations for medicines within 30 calendar days,
with an average of 14 calendar days or less for Phase I trials;
– capture promptly reports of ADRs, initiate timely and appropriate
action to protect public health, ensure they are available for
evaluation and analysis within a maximum of: three working days of
receipt for fatal adverse drug reactions; five days for serious
reactions; and seven days for identification and transmission of
suspected medication errors to the NPSA; and
– continue to improve the transparency of MHRA decision-making and
accountability to the public by: publishing UK Public Assessment
Reports for products licensed within 60 days of final determination;
providing summaries of the evidence supporting major safety decisions
within one month of final regulatory decisions; introducing the
quarterly publication (as appropriate) of identified drug safety
signals and MHRA actions to ensure transparency; and ensuring that at
least 85% of requests under the Freedom of Information Act are
replied to within 20 working days.
