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Japan regulators to speed up drug approval

The Japanese government has said it is devising plans to accelerate drug development and regulatory approval time to allow faster access to medicines for patients

The Japanese government has said it is devising plans to accelerate drug development and regulatory approval time to allow faster access to medicines for patients.

Japan, which is the world's second largest pharmaceutical market in terms of value, is infamous for being overly slow in approving new treatments, with drugs coming to market on average four years 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.

A Japanese Health Ministry committee has called for the time it takes for 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 ministry also wants to increase the number of reviewers for new drugs and facilitate the simultaneous clinical testing of drugs by pharmaceutical companies in Japan, the US and the EU.

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 Japan drug trials 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 18 April.

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.

25th April 2007

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