Why does drug approval take so long in Japan?

“Partly this is because Japanese regulators, with more than 14,000 drugs listed for government-funded medical benefits (Australia has about 600), demand more stringent proof that a new drug is not only safe, but more effective than those already on the market. But there is more than a suspicion that this is just window-dressing for a government policy designed to protect Japan’s fragmented and backward pharmaceutical industry from foreign competition” Princess Masako pg 255

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