China proposes ways to speed up approval for imported drugs
It can currently take up to three or four years for a new drug to reach market in China, slowing patient access to the latest medication. It also means that the Chinese market is dominated by the domestic pharmaceutical industry, limiting the pool of drugs to treat patients with. This could be set to change as the China Food and Drug Administration (CFDA) has submitted proposals to speed up the rate at which foreign drugs are approved for use.
The changes would see the necessity of foreign approval or for the drugs to be going through Phase 2 or 3 trials dropped before being allowed to undergo International Multicenter Clinical Trials (IMCT) in China. This would mean the drugs would only need to be approved by the IMCT before being allowed to use for treatment in patients.
On top of this, the proposals also include scrapping regulations requiring approval in the country where the manufacturer is based. The proposals contain provisions for certain drugs to be prioritised through the process, which includes metabolic drugs, antibiotics and cancer treatments.
The changes would see strong competition enter into the Chinese drug market – with the domestic pharmaceutical industry likely to take a hit as a result of the changes.
However, the current system is under pressure from the public as treatments are often unaffordable or unavailable. This has led to a growing ‘grey market’ where the public are able to buy medicines at a cheaper price but running the risk of potentially being exposed to counterfeit pharmaceuticals.
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