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CHINA'S SFDA EXTENDS APPLICATION DEADLINE FOR NEW GMP


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2014-04-24 07:30:35 - The SFDA made an announcement that manufacturers of blood products, vaccines and sterile injections must have received their newly revised GMP certification in order to market their products after January 1st, 2014.

The SFDA made an announcement on December 31st, 2013 ( www.sfda.gov.cn/WS01/CL0087/95646.html) that manufacturers of blood products, vaccines and sterile injections must have received their newly revised GMP certification in order to market their products after January 1st, 2014.

As such, if they have not received the GMP certification (2010 revision), these manufacturers can sell any products that have been produced and packaged prior to December 31st, 2013. However, if the goods have been produced, but not packaged prior to December 31st, 2013, the manufacturers of blood products, vaccines and injections must hold onto their stock until after the new certification is received.

The SFDA also made clear that if the facility has adopted the new GMP standards, has had an on-site inspection

and passed, but hasn't received the new GMP certification yet, they can continue to produce their products. However, these factories must keep the products off of the market until their new GMP certification is received.

If after January 1, 2014, manufacturers of the aforementioned products haven't adopted or applied for the revised GMP certification, they must apply. Furthermore, they must stop production and shut down their facility until they pass, or they will be punished for illegally producing such goods.

To further clarify, this does not apply to all pharmaceutical manufacturers in China, as there are different deadlines for manufacturers of different products. The SFDA made an announcement, giving beneficial treatment to some and outlining deadlines on January 8th, 2013 ( www.sfda.gov.cn/WS01/CL0051/77486.html), to accelerate new GMP adoption. It stated that manufacturer's that have already acquired GMP from an international organization (such as WHO or by a PIC/S member organization) would be given preferential inspection and certification treatment. Also, they may receive immediate certification if their production lines and company policies are already in line with China's new GMP requirements.

Sterile injection manufacturer's were originally given the deadline of July 1st, 2013 to apply for the new GMP (which has since been extended), while manufacturers of other pharmaceutical products are given until January 1st, 2015 to apply for the new regulation or face shut down. New drug manufacturers are excluded from such timelines and can apply when their new workshops are ready.

It should be noted that a final deadline for currently existing manufacturers of blood products, vaccines and sterile injections to apply for the new GMP has not been issued.

Article can be found at: www.mercatorpharma.com/index.php/news/sfda-extends-application-d ...

Company website: www.mercatorpharma.com/.


Contact Information:
Mercator Pharmaceutical Solutions



Contact Person:
Rick Narner

Phone: +86 21-6240-0367
email: email

Web: www.mercatorpharma.com



Author:
Rick Narner
e-mail
Web: www.mercatorpharma.com
Phone: +86 21 6241 7021

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