Wednesday, July 1, 2009

Chinese CROs trial express customs clearance

PharmaTimes reports that, three contract research organizations (CROs) operating out of China’s Zhangjiang Hi-Tech Park are trying out a new express customs clearance model that could eventually be extended to other CROs in the Park. Its been well-known that customs clearance for CROs has been a difficult process for many CROs, with the new customs clearance model high import/export volume and strict storage requirements could be alleviated.

What other processes can help CROs allevaite tight customs clearance requirements?


Chinese CROs trial express customs clearance
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1 comment:

  1. angelaJuly 2, 2009 at 7:16 PM

    According to Insider Analysis: Pharmaceutical Outsourcing to China, Companies contemplating outsourcing arrangements with Chinese companies to handle clinical trials, contract research or manufacturing should be aware of some of the major regulatory issues in China's pharmaceutical industry – as identified by the People's Republic of China (PRC) government – which may have an impact on outsourcing. Several of the issues frequently encountered by companies outsourcing to China are listed below; practical solutions for dealing with those issues also are discussed.

    In the wake of the corruption scandals involving the top leadership of China's State Food and Drug Administration (SFDA), as well as the deaths caused within China and in Central America by fraudulently produced drugs or bulk pharmaceuticals, the State Council has identified a litany of problems in the regulation of medical products:

    • fraudulent approval of registration of drugs;

    • fraud in implementing good manufacturing practices (GMPs) (i.e., Chinese GMPs), particularly in the manufacturing of injectable drugs;

    • local government interference in the monitoring of drug safety;

    • fraud in research submissions;

    • fraud in clinical trials;

    • fraudulently approved medical devices;

    • fraudulently approved drug distribution companies; and

    • inadequacies in informing the public about drug safety emergencies and adverse reactions.

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