Pharmacy
— market authorisation
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Obtaining
a licence
Before a product
can be marketed in the UK a product license must be issued by the
Licensing Authority. A licence will only be granted by the Medicines
and Healthcare Products Regulatory Agency (MHRA) after the applicant
has been able to demonstrate that the medicine meets the its criteria
of safety, quality and efficacy. These are sometimes referred to
as the ‘three hurdles’.
- Safety evaluation
begins with the examination of toxicological data in a number
of areas. These include short, medium and long-term studies in
animals of mutagenicity, oncogenesis and teratogenicity.
The UK government
plans to establish a national centre, which will coordinate
work into the replacement, reduction and refinement of the use
of animals in medical research. Announcing the centre, science
and innovation minister, Lord Sainsbury said:
‘While
I believe that animals still need to be used in research and
testing, I also believe strongly that a major opportunity now
exists to make progress in replacing, refining and reducing
the use of animals and improving their welfare.’
Home Office
minister, Caroline Flint, endorsed these sentiments:
‘The
UK has one of the most rigorous licensing systems for animal
experimentation in the world… But it is vital we maintain
the good progress that has already been made.’
Funding
for the so-called ‘three Rs’ is set to double from
£330,000 to £660,000 with further increases expected
in the future. The move received a warm welcome from many parts
of the industry. The ABPI’s science and technology director,
Dr Philip Wright, said:
‘We
are confident that this will add further impetus to the many
initiatives under way that aim to replace the number of animals
used in medicines research with other methods, reduce those
that still have to be used and further refine procedures to
ensure even higher welfare standards.’
- Quality evaluation,
in relation to pharmacy and chemistry, begins by a definition
of the chemical structure and then a description of the method
of production defining the synthetic route used. A description
of the physico-chemical properties is required as well as details
of product formulation, impurities, sterility and shelf life.
Paediatric
medicines
A new initiative
to encourage the development of more medicines designed specifically
for use in children has been announced by the health minister, Lord
Warner. Most medicines are obviously designed for and tested on
adults but are widely prescribed for children. The evidence shows
that children and adults respond very differently to medicines and
that a treatment effective in adults may not be as suitable for
children. New European legislation in this area will come through
in 2006 and these new plans are part of a shorter term strategy
to encourage companies to get cracking now. They will also make
sure prescribers have better information about the effect of medicines
on children. The details of this new paediatric strategy are available
at the Medicines
and Healthcare products Regulatory Agency (MHRA). The
full document talks about the ‘reluctance’ of companies
to develop paediatric medicines because of ‘ethical concerns
about, and the practical difficulties of, conducting trials in children,
together with commercial considerations’.
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