In an effort to boost the efficiency and transparency of the application and review process, the China NMPA has announced a draft guideline for the review and acceptance of the registration of chemical and biological drugs. With regard to the acceptance of submissions, an online system will be adopted for filing the application form. The completeness check after submission will be conducted on electronic dossiers, rather than the hard copies.
Regarding the patent linkage system, the applicant is required to make declarations for the drug patents related to generic drugs (reference drugs – drugs with the same name and prescription) and compare them verse the information in the patent disclosed by the CDE’s Drug Patent Information Registration Platform.
Another major change is an addition of a classification code to the Drug Production License for statistical classification in accordance with the Drug Production Supervision and Administration Measures. The applicant may also specify the CMO model or in-house manufacturing model, in addition to the MAH information and manufacturing site information.