Updated on 25 April 2012
He adds that the ICH may gradually open its gate wider to other parts of the world, including Asia, and "the whole world can comply with a single standard for biologics manufacturing, such as the ISO system".
Sharing a brighter side of China's regulatory compliance, Bio Plan Associates shares that Chinese biologics are approved for export to Africa, Middle East, Nepal, and some other countries. However, China is not exporting to developed regions, because it does not qualify the cGMP guidelines for biopharmaceutical manufacturing.
"This is changing because some companies are now designing and installing fully compliant cGMP facilities for contract biopharmaceutical manufacturing. Those are led by capable teams with experience from the US and Europe and will be in line for domestic operations in the next three to five years. In addition, multinational pharmaceutical companies continue to look at potential CMO partners in China. Some of the interest in China outsourcing may be derived from general interest in establishing such relationships," says Mr Eric S Langer of BioPlan Associates.
Biological manufacturing has been recognized as a promising field by the government and several measures have been taken by the central and local governments on different aspects, such as financial, regulatory and services. National funds, including the National Twelfth Five-Year-Plan and the National ‘863' Program are the local funds that strongly support the development of biomanufacturing. Funding from the government combined with other private funds are now actively seeking opportunities in the biomanufacturing area.