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Chinese Pharmaceutical Enterprises Need to Be Cautious When Entering into the European Pharmaceutical Market -3

Post Time:2009-01-21 [Large Middle Small] View:
The MA in one EU member state can be used as the reference for the review and evaluation in the second country, which may save a lot of time. However, for innovative drugs, certain biological agents and other products, the assessment and approval in different countries are independent and strict from each other.
At the same time, the pharmaceutical enterprises need a lot of expenditure. These costs include the administrative examination and approval fee such as the registration of certification, which is only one very small part of the cost like about ? 10,000 for MA, and the cost of production management, quality control, the improvement of production lines to meet the GMP requirements and clinical trials, which is the large part. The registration of generic drug in Finland, an example of registration fee, needs about ? 9500 to obtain MA, the cost of review and approval of changing the form or the efficacy of drugs is about ? 3800, the cost of application for traditional herbal medicine is ? 3800.
On the other hand, if the product is needed to conduct clinical trials in Europe, the cost will be quite huge.  The clinical trials could be completed in China, but must ensure the integrity of data of clinical trials, and the Chinese pharmaceutical enterprises could ask the European expert advice for advice and guidance. According to different products, the works needed to be completed before the access to the European market are different, and the costs of clinical trials are different from one million euros to more than 100 million euros.


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