(Yicai Global) Oct. 24 – China's Food and Drug Administration (FDA) has sought public opinions on its Drug Registration Management Measures intended to protect the data applicants submit when registering for innovative drugs and those for rare diseases.
Data protection shall apply to innovative drugs and those for treatment of rare diseases, special medicines for children, innovative therapeutic biological products and their test information, as well as other data submitted by successful patent applicants themselves and still undisclosed, Chinanews.com reported Oct. 24.
The data protection period begins from the date of drug approval. In the period of protection, the drug regulator will no longer approve licensing applications for products of the same type. Specific management requirements for data protection are separately formulated.
The measures also prescribe a system for holders of marketing authorization and require them to assume legal liability for the listed drug's safety, efficacy and quality control. The FDA reviews and approves clinical value oriented drug registration as a priority, it said.