12 Nov 2019
China Releases First List of Priority Drugs for Generic Manufacturing
China recently published its first catalogue of drugs deemed to be in short supply, with patents that have either expired or are approaching their expiration date and where applications for re-registration have not been forthcoming. All 33 listed items are to be considered as eligible to be manufactured in a generic form.
Among the medical products duly designated for this purpose are:
- Nitisinone (capsules)
- Fomoterol Fumerate (inhalation solution)
- Posaconazole (enteric-coated tablets)
In the case of all listed items, approval from the relevant government department must be secured prior to any clinical testing, the commencement of research on any related generic technologies, application for a priority review or any other regulated activity.
Full details of the catalogue and other associated items can be found in the Circular on the Issuance of the Catalogue of the First Batch of Encouraged Generic Drugs (Guo Wei Ban Yao Zheng Han No. 744 ), as jointly issued by the National Health Commission and four other government departments.
Source: National Health Commission