Pharmaceutical raw material management regulations are expected to be released during the year

Zhang Wei, Director of the Drug Registration Department of the State Food and Drug Administration, introduced at the 9th China International Forum on New Drug Development Advanced Technology and Industrialization Development. The text of the “Regulations on the Administration of Pharmaceutical Raw Material Registration” is expected to be released this year. The guiding principles will also be introduced one after another, and related companies will be given a longer transition period.

It is understood that pharmaceutical excipients and packaging materials are one of the key areas and directions for the development of China's biomedical industry. The next five years will promote the development of serialized and functional pharmaceutical excipients that will improve the performance of drugs, provide special functions, and ensure the safety and efficacy of drugs.

In order to strengthen the management of pharmaceutical excipients, in September 2010, the State Food and Drug Administration drafted Regulations on the Administration of the Filing of Pharmaceutical Raw Materials, and publicly solicited opinions. The draft of the Opinions pointed out that pharmaceutical preparation research institutes and manufacturing enterprises should carry out full research and verification of the selected raw and auxiliary raw materials for pharmaceuticals. At the same time, they should also audit the qualifications of raw and auxiliary materials suppliers and the production quality assurance system to form a supplier audit report. When the Drug Review Center of the State Food and Drug Administration reviews an application for the registration of pharmaceutical preparations, the information on the use of raw and auxiliary materials for pharmaceutical preparations shall be used as part of the application materials for preparation for review.

According to industry sources, the current domestic pharmaceutical excipients account for 2%-3% of the output value of the formulation, which is lower than the general level of 10%-20% in foreign countries. With the continuous improvement and standardized development of industry standards, there is a huge room for growth in the domestic accessories market. Among the listed A-share pharmaceutical companies, the southwest synthetic and upcoming Aer Kang pharmaceuticals are more concerned. Huabei Pharmaceutical announced on September 15 that its research and development of “Pharmaceutical Excipient Grade Recombinant Human Blood Albumin” obtained the “Drug Production License” from the Hebei Province Food and Drug Administration and clinical trials have been initiated.