China: Quality Management project for Food for Special Medical Purposes
The Chinese FDA recently issued the trial version of a quality management project on Food for Special Medical Purposes (FSMP).
The project is a detailed rule on clinical trial implementation. It includes conditions, research protocols, organization, monitoring, recording, duties and rights of applicants, investigation and monitoring, quality control, data management, statistics and analytical plan, overall conclusions and reports. Besides these issues, manufacturing companies have the right to find a plant which they want to cooperate with and set up a suitable plan without the intervention of the Government. The FDA acts as inspector and monitoring body.
This is the first time that the Agency gives a direction for food for special medical purposes because most of it depended on foreign trade business before this trial.
In China, there is a huge amount of patients who suffer from diabetes and nephropathy, but FSMP study is very poor; the trial version will offer a new business chance to relevant companies.
