4、Adopting associated appraisal step by step to establish a scientific and effective evaluation system
In China’s traditional structure and mechanism of drug appraisal, separate appraisal and regulation are conducted on drugs, pharmaceutical excipients and pharmaceutical packaging materials. Despite its advantage of clear management structure for different industries, such a separate management mechanism has shortfalls when it comes to comprehensive evaluation and regulation on drug quality. The major problem is that appraisal institutions are unable to combine the quality of excipients and packaging materials with their usages when evaluating whether the excipients and materials meet the sales requirements.
An old joke in pharmaceutical industry goes like that “API is added by bad excipients and loaded into bad bottles, which turns into the drug for our use.” The joke reflects the reality that many excipient industries associated to drugs cannot meet the drug requirements since the current separate management drives pharmaceutical researchers and developers to focus on whether excipients and packaging materials are qualified for regulations instead of their appropriateness and quality.
After long-term appeal by pharmaceutical professionals, people in charge of CFDA registration management have recently revealed at meetings the incoming adjustment in registration management of excipients and packaging materials. The authority plans to replace separate registration approval with associated appraisal during the application of drugs and preparations from 2015.
