If you manufacture drugs in China — or you plan to — you need to master China’s new GMPs. China adopted updated GMP regulations in 2011 — effective immediately for new plants and no later than 2015 for existing facilities.

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Some key differences between China and the US and EU:

• A plant’s certification to operate following inspection in China is valid for only 5 years.
• China spells out specific education and professional requirements for quality directors, production managers and authorized persons.
• The quality department is to be completely autonomous under Chinese GMPs.
• China has specific requirements for the locations of plants relative to the local environment to address Chinese pollution concerns.

The revisions also make significant changes from prior Chinese GMPs, including:

• New requirements for documents, such as SOPs, not addressed before
• Adoption of ICH-style risk-management guidance for creating quality systems
• New requirements for CAPA
• New standards for sterile production that match EU requirements

Only one guide aims specifically to help non-Chinese drug manufacturers get into compliance with China’s GMPs. By special arrangement, that guide is now available to FDAnews clients.

Based in Nanjing, Access China Management Consulting Ltd. specializes in helping foreign firms navigate the often-baffling Chinese drug market.

The new Chinese rules run 14 chapters and 313 articles. Latest Guide to Chinese Pharmaceutical GMP Regulations summarizes and explains them in an easy-to-understand digest covering all the provisions you need to be aware of.

China’s pharmaceutical market is projected to become the world’s second-largest in 2015. In 2015, where do you want to be? If you answered “China,” order your copies of Latest Guide to Chinese Pharmaceutical GMP Regulations now.

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Latest Guide to Chinese Pharmaceutical GMP Regulations is available in pdf format only (7 chapters, 136pp.) for $750. Act now: place your order here.

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