|
|
May 8, 2007: The Japanese are learnt to
be working to cut short the time frame for drug
approval process. A committee formed by the
Japanese Health Ministry has called for the time
it takes for a new drug to receive market approval
in Japan to be reduced to around 18 months, a wait
similar to that in the US. The waiting time
reduction has a deadline of 1 April 2011 (end
FY10).
The Japanese pharmaceutical market has been
notoriously slow in approving new drugs. This
really posed a strong barrier for companies from
other countries to enter the world’s second
largest pharmaceutical market in terms of value.
It took four years on average approving new
treatments, after they have first been sold
overseas. The process is often retarded by high
costs and a lack of volunteers for clinical
trials, which has an impact on drug development.
Of 150 new products launched globally between 2002
and 2006, a mere 32, or 22 per cent, have been
launched in Japan, according to IMS data. In
addition, of the world's top selling 100 drugs, 26
remain unavailable in Japan. The Japanese
pharmaceutical market was valued at USD 56.7bn in
2006, added IMS.
The number of reviewers for the new drug approval
process will also be increased to facilitate the
simultaneous clinical testing of drugs by
pharmaceutical companies in Japan, the US and the
EU, ministry officials said.
The move is a response to the fact that
pharmaceutical firms have begun simultaneous
clinical trials. Wyeth, for example, has committed
to simultaneous drug development in Japan for all
of its drugs, but qualifies this by saying that it
remains to be seen whether increased investment in
drug trials in Japan will result in quicker
approval times.
However, Wyeth's Effexor (venlafaxine), which is
the most widely prescribed antidepressant, was
still waiting for approval in Japan, despite
positive clinical results and patient outcomes.
A reduction in approval times would certainly
benefit the UK’s number one drug company,
GlaxoSmithKline (GSK), which received approval for
two key drugs from Japanese regulators on April
18, 2007.
GSK’s asthma product, Seretide/Advair Diskus (salmeterol
and fluticasone), and anti-thrombotic, Arixtra (fondaparinux)
won approval from the Japanese Ministry of Health,
Labour and Welfare. Seretide/Advair will be
marketed as Adoair Diskus and was approved for
adult patients with bronchial asthma when
additional use of an inhaled corticosteroid and
long-acting beta-agonist is necessary. Adoair will
be the only combination respiratory medicine
available in Japan, targeting inflammation and
broncho-constriction, the two main causes of
asthma.
Swiss pharmaceutical firm, Roche, which owns a
majority stake in Chugai Pharmaceutical, would
also benefit from reduced approval times, while
Pfizer, which controls over five per cent of the
total Japanese pharmaceutical market, also has
many products pending.
BY OUR PHARMA CORRESPONDENT
|
