| answer text |
<p>In order for a human medicinal product to be granted a marketing authorisation,
legislation requires robust data to be generated to demonstrate satisfactory quality,
safety and efficacy of the proposed medicinal product and show that the benefit to
risk balance is positive in the intended patient group.</p><p>Studies to evaluate
the toxicity profile of a medicine using in vitro or animal models are generally performed,
prior to initial safety studies (Phase I) in human volunteers. Further clinical trials
(Phase II and III) are then typically performed to establish safety and efficacy in
patients, prior to the submission of a marketing authorisation application.</p><p>The
Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for the
regulation of medicines in the United Kingdom. At this time, the MHRA is not aware
of any clinical trials having been planned or conducted on a product that is for oral
administration to enable imaging or identification of breast cancer. Therefore, at
present, it cannot provide a timeline for the licensing of such a medicine.</p>
|
|
