How Regulatory Decisions Are Made - Comments Invited - MHRA, UK
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This document sets out:
-- the main regulatory decisions that are made about medicines and medical devices;
-- the principles that inform these decisions;
-- the questions that are considered to ensure that the decisions are reasonable, and
-- who makes decisions about medicines and medical devices - which includes bodies other than MHRA.
MHRA has drafted the document after consultation with a range of external stakeholders, including healthcare professionals, bodies which represent patients and the public, and the pharmaceutical and medical devices industries.
MHRA invites further comments on it. MHRA will consider all comments and expect to publish a revised version in the summer of 2007. Please e-mail any comments to john.watkins at mhra.gsi.gov.uk (at = @. @ was taken out to prevent spammers from picking up the email)
-- You may want to mark up your comments on the Word version of the document, save it on your own computer and then e-mail it back to us.
-- If you prefer just to use a simple e-mail, please make sure you note the page(s) and paragraph number(s) your comments refer to.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
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