China FDA wants to end use of intermediaries on drug approval process

China's cabinet, the State Council, has circulated a proposal to tighten up the practice of using insiders and others as intermediaries to get access to drug and other regulators and their approval processes.

The circular said the third parties hired to deal with the bureaucracy "often have government links," creating an atmosphere for administrative and bureaucratic corruption. The council said the practice also is a source of delay in granting approvals.

The council also criticized intermediaries as often arbitrary in what they charge their clients, highly monopolistic and disruptive of the market order. It ordered intermediaries to specify clearly for their clients the administrative procedures required by law that they will face.

In order to prevent a monopoly of service providers, they would be required to ensure that any person or group wishing to do so legally be allowed to serve as an intermediary. At the other end, government officials would not be allowed to limit the number of service providers they deal with.

Another provision would separate the services provided by industry and commercial associations from the government body responsible for reviewing and approving their applications. Also, government officials would be banned from working for intermediaries.

Drugmakers and companies in other regulated industries usually hire intermediaries familiar with China government regulations and procedures to take their products through all the steps to approval.

The new guidelines would also help eliminate the time wasted by government officials in dealing with the intermediaries as well as being a burden on the companies and general public.

- here's the release from CFDA

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