http://blog.pharmtech.com/2011/08/09/reinventing-a-national-manufacturing-strategy/ The blog of Pharmaceutical Technology magazine Thu, 09 May 2013 23:30:55 -0400 http://wordpress.org/?v=2.8.4 hourly 1 http://blog.pharmtech.com/2011/08/09/reinventing-a-national-manufacturing-strategy/comment-page-1/#comment-39738 cliffintokyo Mon, 15 Aug 2011 08:57:59 +0000 http://blog.pharmtech.com/?p=4508#comment-39738 A 'national manufacturing strategy', even just for pharma, may be a little too 'socialist' a concept for many US pundits. US gov/FDA probably does need to bring US pharma together to seriously consider the risks of not having a manufacturing base of excellence in quality within the US for producing complex NCE APIs, biotech APIs, and specialist Drug Products, perhaps solely (or mainly) for the US market. Overseas factories operated by US pharma should probably produce products for overseas markets, with regulatory enforcement by local authorities, according to their own standards. A ‘national manufacturing strategy’, even just for pharma, may be a little too ’socialist’ a concept for many US pundits.
US gov/FDA probably does need to bring US pharma together to seriously consider the risks of not having a manufacturing base of excellence in quality within the US for producing complex NCE APIs, biotech APIs, and specialist Drug Products, perhaps solely (or mainly) for the US market.
Overseas factories operated by US pharma should probably produce products for overseas markets, with regulatory enforcement by local authorities, according to their own standards.

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