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The pharmaceuticals and drug regulation agency in China has announced a steep hike in drug and medical device registration fees. The country, which is the second-largest medical devices market in the world, has taken this step as it find it increasingly difficult to process the glut of applications on account of skilled experts and resources.
With the new regulations coming into effect, the fees for registering a new drug that is made domestically will jump to 624,000 yuan (or US$ 100,637). In 2013, this rate was just 35,000 yuan. The announcement came from the China Food and Drug Administrator (CFDA) on Wednesday via an official statement.
Explaining this decision, the regulator said in the statement that it was facing tremendous delays and difficulties in handling applications for medical device and drug registrations. Given that examining such approvals calls for the deployment of considerable amounts of money and resources, the regulator was compelled to hike the fees for registering medical devices and drugs in China. This cost will now be directly shouldered by the applicants, the regulator informed.
However, gauging from immediate reactions, market players were far from disappointed. They opined that if the increase in fees is expected to make the application process smoother and faster, the move would be welcome. According to the CFDA, the country’s fees were comparatively lower than countries such as Japan and the United States.
Currently, the drug and medical devices approval machinery in China continues to reel under the deluge of applications and requests. According to official figures, about 18,500 drugs were pending approval as of 2014 end. The fees are charged differently for generic drugs, imported products, and medical devices. While registering a generic drug could cost US$ 81,897, the same for an imported drug could be US$ 156,423.
This is the first time since 1995 that the country has announced a revision in the drug and medical devices approval fees.
This Press Release (Applications for Domestic Drug and Medical Device Approvals to Cost More in China) Distributed By CULRAV.ORG http://www.culrav.org