Industry News

The EG.5 substrain of the Omicron variant of COVID-19 has become the most prominent source of coronavirus infections in China, the Chinese Center for Disease Control and Prevention said on Saturday.

Recently, another traditional Chinese medicine (TCM) compound preparation Pipa Qingfei granules regulated as one of the ancient classic formulae (which is a category 3.1 innovative TCM) is approved for marketing through technical evaluation. The formula of this TCM is derived from the Yi Zong Jin Jian (Golden Mirror of Medicine) by Wu Qian etc. from Qing dynasty, and enlisted in the Directory of Ancient Classic Formulae of Traditional Chinese Medicine (the first directory). The marketing authorization holder of this TCM is Jilin Aodong Taonan Pharmaceutical Co., Ltd.

Recently, the new traditional Chinese medicine (TCM) compound preparation Qijiao Tiaojing Granule of Hunan Anbang Pharmaceutical Co., Ltd. was approved for marketing by China NMPA.

Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Shenge Bushen Capsule of Xinjiang Huachun Biological Pharmaceutical Co., Ltd was approved for marketing by China NMPA.

Recently, the innovative product Single-port Laparoscope Surgery System of Beijing Surgerii Robotics Company Limited is approved by China NMPA.

To further standardize the regulation on labels of prepared slices of Chinese crude drugs, in accordance with laws, administrative regulations and provisions including the Drug Administration Law of the People's Republic of China, the Regulations for Implementation of the Drug Administration Law of the People's Republic of China and the Provisions for Drug Insert Sheets and Labels, the NMPA organized to formulate the Rules for Labels of Prepared Slices of Chinese Crude Drugs, which is hereby released and shall be implemented since August 1, 2024. The labeling of expiration date according to the Rules shall be implemented since August 1, 2025.

Recently, the Category 1 innovative drug Anaprazole Sodium Enteric-coated Tablets of Xuanzhu (Beijing) Pharmaceutical Technology Co., Ltd. is approved by China NMPA. It is an innovative drug independently developed in China and has independent intellectual property rights, indicated for the treatment of duodenal ulcers.

To align the technical standards for drug registration with international standards, the NMPA upon deliberation decided to adopt the ICH(International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) Guidelines M10: Bioanalytical Method Validation And Study Sample Analysis (hereinafter referred to as M10) Q&As documents and FAQs documents. The relevant items are hereby announced as follows:

Recently, the Category 1 innovative drug Retagliptin Phosphate Tablets of Jiangsu Hengrui Pharmaceuticals Co., Ltd. is approved by China NMPA. It is indicated for improving the blood glucose control for adult patients with type 2 diabetes

Recently, the Category 1 innovative drug Oteseconazole Capsules of eVENUS PHARMACEUTICAL LABORATORIES INC. is approved by China NMPA. It is indicated for the treatment of severe vulvovaginal candidiasis (VVC).