On August 18, 2008, the CFDA official website explained the relevant issues of the release of the reference preparation, and made the following points:
A product produced by the same manufacturer may be regarded as equivalent in the same company under the same company.
Second, the certificate is different under the same head office supply, the products of the same manufacturer, if you can provide appropriate evidence to prove that different licensed commercial product prescription, production technology and product quality are the same, can be treated as equivalent.
Three, the holder of the same business supplies, the public products of different regions, such as to provide appropriate evidence of different origin product prescription, production technology and product quality are the same, can be considered as equivalent; Otherwise, it is generally not considered equivalent, and the origin in the list of reference is subject to the origin.
Four, because of the slow-release controlled-release there may be multiple reference preparations, so the reference formulation selection expert review will only enterprise has been put on record for review, confirm the reference preparation for the record as the reference preparations, the reference formulation may not be applicable to other enterprise products, such as can not apply separately for the record.
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