Since 2006, the National Center for Drug Evaluation (CDE) under the National Medical Products Administration (NMPA) has no longer distinguished between "sustained-release" and "controlled-release" preparations in naming based on their in vitro release characteristics, but has uniformly named them "sustained-release preparations". When JUPOPINE^® was approved for marketing in 2010, despite its technical attribute being a controlled-release preparation, it was named "Nifedipine Sustained-Release Tablets (Ⅲ)" in accordance with the regulations at that time. The suffix "(Ⅲ)" is not suitable to clearly reflect its controlled-release attribute.

• The renaming work was once at a standstill

  To "rectify the name" of JUPOPINE^®, we submitted applications multiple times and raised the issue again during the review of the consistency evaluation of the quality and efficacy of generic drugs. Six relevant departments also held multiple rounds of inter-departmental coordination meetings to advance the renaming process. However, due to epidemic prevention and control measures at that time, review experts were absent on multiple occasions, causing the review process to be delayed and unable to proceed effectively. The renaming work was once at a standstill.

• The change of generic name has been successfully completed

  In 2020, when JUPOPINE^® was about to pass the approval for the consistency evaluation of the quality and efficacy of generic drugs, our company reported the difficulty in renaming to higher authorities. This case received high attention from the central government. Upholding the principle of treating domestic and foreign-invested enterprises equally, the government fully protected the legitimate demands and fair development rights and interests of foreign-invested enterprises, and finally promoted the smooth completion of the generic name change.

  The Chinese Pharmacopoeia Commission and CDE re-examined JUPOPINE^®’s technical characteristics and confirmed that it meets the standards for osmotic pump-type controlled-release preparations. Accordingly, the generic name of JUPOPINE^® was officially corrected to "Nifedipine Controlled-Release Tablets", and it was also clarified that the product is bioequivalent to the innovator drug.