Clinical trials regulations now in force
MHRA update
A new management structure has been introduced at
the MHRA. Pharmacists Gordon Munro (responsible for inspection)
and Clive Bray (responsible
for device technology evaluation and safety) are among those who
sit on the executive board, which takes strategic direction from
the agency board, which itself includes the MHRA executive chairman
Sir Alasdair Breckenridge, chief executive Kent Woods and six
non-executive directors drawn from the private and public sectors. |
New regulations concerning how clinical trials are run came into force on 1 May. The Medicines for Human Use (Clinical Trials) Regulations
2004 are designed to ensure that the rights, safety and well-being of clinical
trial subjects are protected, by requiring sponsors of trials to be responsible
for designing, conducting, recording and reporting trials according to
internationally recognised principles of good clinical practice. They also
require good manufacturing practice standards to be applied to the preparation
of products used in clinical trials, provide for inspections to be carried
out and grant enforcement powers.
The regulations implement the EC Clinical Trials Directive. Consideration
of some of their likely implications was set
out in last December’s issue of Hospital Pharmacist (p495).
The Medicines and Healthcare products Regulatory Authority (MHRA) has updated
its website accordingly (see www.mhra.gov.uk). Information on transitional
arrangements and obtaining a “EudraCT number” (clinical trial
identifier) online is set out. Also included are details about applying
for a manufacturer’s authorisation and becoming a “qualified
person” under the regulations. A statement about the responsibilities,
liabilities and risk management of clinical trials, including for product
manufacturers and any pharmacists who act as investigators, is also contained.
Guidance on preparing “site master files” for staff working
at units holding or applying for licences relating to small-scale manufacture
(eg, the making of “specials” and clinical trial products)
was published on 14 April. It is available via the MHRA website
(details above) or directly as a PDF file
(160K).
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Hospital Pharmacist