As China emerges as a significant supplier of pharmaceutical ingredients, it must assure other countries of the safety
of its excipients. China's State Food and Drug Administration (SFDA) intends to revise its excipient-control regulations to
protect consumers at home and abroad. The agency has begun to meet with international trade organizations such as the International
Pharmaceutical Excipients Council (IPEC) to hear industry's concerns. The author describes the contacts between SFDA, IPEC,
and other international bodies. The article explains what SFDA has learned and how it may adjust its regulations for the future.
As China's role in the global pharmaceutical market increases, the Chinese State Food and Drug Adminstration (SFDA) and many
China-based pharmaceutical manufacturers and excipient producers are beginning to collaborate with their international counterparts
on excipient-control issues. Compliance with appropriate good manufacturing practices (GMPs) throughout the entire excipient
distribution supply chain and an understanding of international regulatory and pharmacopeial excipient controls are critical
components for ensuring that pharmaceutical excipients are safe and of acceptable quality. The recent tragedies related to
contaminated glycerin and other products sourced from China underscore the need for safe excipients.
China's proposed new license requirements for the manufacture and use of excipients
During the last two years, several regulatory developments related to the manufacture, importation, and use of excipient ingredients
in China have taken place. In the past, China has required certain types of licenses for the manufacture and use of excipients
in the country. Recent proposed changes to the registration requirements, however, could significantly affect the future availability
of excipients produced in China for the country's domestic market and for export.
SFDA issued new Drug Excipients Registration Application Materials requirements on June 21, 2005. The regulation covered various
excipient-registration requirements, including those for imported excipients. In December 2005, SFDA revised these requirements
and proposed a new set of regulations to control excipients used in products marketed in China. The regulations would establish
new GMP and manufacturing rules for excipients produced in China and new requirements for obtaining an import license for
pharmaceutical excipient ingredients that are produced outside of China.
To obtain an import license under these proposed regulations, excipient manufacturers would be required to provide additional
detailed information concerning the manufacture of their pharmaceutical ingredients and specific additional data to substantiate
the excipient's safety for its intended use. The regulations would apply to new excipients and commonly used compendial excipients
that have been used for years in China. The level of data and information that the proposed regulations would require significantly
exceeds what has been previously required in China. The requirements also exceed the amount of information generally required
in other major market countries, especially for compendial excipients. The proposed regulation would require the pharmaceutical
manufacturer to obtain a copy of the license for each excipient in its formulation from each of its excipient suppliers to
support the use of these excipients in drug products made in China.
Proposed regulations for excipients that are produced domestically in China are similar to those for excipients that are imported
into China from foreign manufacturers. Domestic excipient manufacturers must meet a higher quality and GMP standard than China
has typically required in the past, and they must supply more information to SFDA about their products and processes. In addition
to the current requirement of being registered with SFDA, excipient manufacturers would also be routinely inspected for GMP
compliance. The regulations as applied to domestic Chinese excipient manufacturers will significantly affect these domestic
excipients' availability and cost. Additionally, the proposed import license requirements would potentially increase costs
significantly for all multinational excipient companies who intend to supply their excipients to China. The requirements could
cause some companies to stop supplying the Chinese market because of cost and intellectual-property concerns.
The licensing requirements for imported excipients are somewhat different from those for domestic Chinese manufacturers and
contain many criteria that are especially difficult for many excipient manufacturers to meet (see sidebar, "SFDA's proposed
requirements for obtaining an import license").
SFDA proposed requirements for obtaining an import license