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Sunday, December 24, 2006


A recent FOI request to the MHRA was finally 'answered' by Andrew French, Group Manager, Licensing Division of the MHRA. I would be grateful if anyone out there could determine the definition of the cleverly constructed language he uses?

Mr Robert Fiddaman

19th December 2006

Dear Mr Fiddaman

REF: FOI 06/384

Thank you for your letter dated 21st November 2006 regarding a request under the Freedom of Information Act (FOIA), and which has been passed to me for reply. You raised several questions which I have reproduced below and which I will address in turn.

I also note from Sir Alasdair’s reply which you quote, that UK Public Assessment Reports (UKPARs) are mentioned. I should point out that UKPARs only came into being for medicinal products authorised in the UK on or after the 30th October 2005, and as such there was no UKPAR for Paroxetine / Seroxat. However,

Returning to your questions;

1) Please explain what is meant by "data". Does it mean

a) the mere existence of trials

b) company interpretation of data

c) the part of the company interpretation of data actually passed to the MHRA

d) the actual raw and complete data.

"Data" generally means the complete data package generated in support of the application submitted to the competent authority. This includes all data seen as both favourable and unfavourable to the support of the licence application as is required by the current European legislation. This data is normally provided in summary format and does not comprise the "raw data", although the regulatory authority can demand this if it is thought necessary. In the UKPAR, "data" are usually summarised rather than reported in full.

2) Will such "data" also include a listing of the data known to exist, but which the MHRA did not use to make its decision. (please answer only yes or no)

As stated above, all data, favourable and unfavourable, must be submitted.

3) Have the MHRA placed such "data" relating to Paroxetine/Seroxat on the MHRA website (answer yes or no). If yes, please refer me to such data

The report of the Committee on Safety of Medicines Expert Working Group on SSRIs was published on the website. This provided summaries of all the data, including clinical trial data, which underpinned the decisions of the group. In the case of paroxetine, clinical trial study reports were examined by the Agency in parallel with MAH analyses of their clinical trials. Link to data below.

4) The word "transparency" was used. Please supply a definition of this word as used in MHRA communications

The release of a national public assessment report for a medicinal product has two aims (i) to give transparency to the regulatory process, and (ii) to provide information on the product and the data supporting its authorisation or refusal. Transparency, as used, means providing all of the data on which the licensing decision was reached, together with the reasons for the opinion of the licensing authority, after deletion of any information of a commercially confidential nature.

I hope this information satisfies your queries

Yours Sincerely

Andrew French
Group Manager, Licensing Division

....and they call themselves transparent!


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