Regulatory Focus™ > News Articles > China: Deadlines Established For Opthalmic GMP Implementation

China: Deadlines Established For Opthalmic GMP Implementation

Posted 30 April 2012 | By Ansis Helmanis

The Chinese State Food and Drug Administration (SFDA) issued a notice on 25 April to Chinese Provinces and Municipalities regarding the deadlines for implementing the revised Good Manufacturing Practices (GMPs) for ophthalmic solutions.

The circular pointed out that the implementation of revised GMPs for sterile pharmaceuticals and sterile bulk drugs is effective as of 31 December 2013.

These sterile bulk drugs include ophthalmic preparations, such as those for intraocular injection, insert agent within the eye for surgery, wound, corneal penetrating injury with ophthalmic preparations, and eye liquid preparations.

These preparations are regulated in accordance with the relevant provisions of the "Chinese Pharmacopoeia (2010 edition)" special provisions for ophthalmic products.

All ophthalmic preparations should comply with the new GMPs as of 31 December 2015.


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SFDA - GMPs for Opthalmic Solutions

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