MHRA asks people what they think of its plans
Consultation
has started on the key challenges and priorities that the Medicines and Healthcare products Regulatory Agency believes it will face over the next five years.
The consultation paper says that the agency’s overall objective
is to safeguard public health by deciding whether the benefits of any
medicine or medical device outweigh its risks and continue to do so throughout
the life of the product. This will require further strengthening of the
agency’s reporting systems and other sources of information.
Second on the MHRA list of priorities is information and communication;
information, because most regulatory action after initial licensing leads
to changes to the information, advice or warnings associated with a product,
rather than to its withdrawal, and communication, because this information
needs to be communicated effectively both to health professionals and
to the public.
The agency also believes that it needs to ensure that the regulatory
system does not make research and development unduly slow or expensive
and that it should enable, rather than hamper, the development of new
treatments.
At an international level, the MHRA is keen to maintain its position
as one of the leading regulators in Europe and worldwide. It notes that
some national regulators in the EU are specialising in particular types
of work, but believes that it should retain expertise across all types
of medicine and enhance its capacity in new areas, such as tissue engineering.
The consultation runs until 2 November 2007 and will include meetings
with organisations that represent patients, the public and health care
professionals,
because the MHRA believes that it needs to foster more effective links
with these groups. The outcome of the consultation process is expected
to be published as a strategy document before April 2008.
The consultation paper is available online
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The
Pharmaceutical Journal
Acrobat
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