BaiPharm Pharmaceutical Regulatory News – Dec 13, 2022
Welcome to the first LinkedIn newsletter of BaiPharm, where you'll find the latest pharmaceutical regulatory updates and industry activities in China.
China Bans a List of Drugs from Online Sales: Vaccines, Anesthetics, and More
08 December, 2022
After consulting the draft list in early November, China National Medical Products Administration issued the List of Drug Banned from Online Sales (1st Version). The list took effect on the same day as the Administrative Measures for Supervising Online Sales of Drugs came into force on Dec. 1, 2022.
The banned drugs are divided into two general categories. Compared to the draft list, the formal list specifies the category 2.2 banned drugs. Other categories stay the same.
China Pharma Industry Sees More M&A Deals
02 December, 2022
More and more mergers and acquisitions (M&A) deals take place in China's pharmaceutical industry. In 2021, Chinese pharma companies participated in a total of 782 domestic and cross-border M&A deals, amounting to 34,436 million USD.1
From 2017 to 2021, the number of M&A deals continuously increased. The total value topped in 2020 due to China's polices for encouraging medical innovation and the relaxation of listing and refinancing rules. In 2021, the deal value slightly declined with fewer huge-value deals.
China Requires Electronic Submission of All Drug Registration Application Documents from Jan. 1, 2023
02 December, 2022
On Nov. 30, 2022, China National Medical Products Administration (NMPA) announced that all documents for drug registration applications, as well as supplemental documents sent during the review, shall be submitted electronically in compact disks with no paper required, from Jan. 1, 2023.
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China Permits Online Sales of Prescription Drugs Nationwide
01 December, 2022
On Dec. 1, 2022, China's Administrative Measures for Supervising Online Sales of Drugs?takes effect, allowing the online sales of #prescriptiondrugs nationwide after regional pilot programs in Hainan and Shenzhen. To ensure safety for selling drugs online, the Measures specifies regulatory requirements for online sellers and third-party online platforms.
Qualifications and Obligations of Online Drug Sellers
Monthly Recap: China Pharmaceutical Regulatory Updates | November 2022
09 December, 2022
Monthly Report: New Drug Approvals in China | November 2022?
05 December, 2022
In November 2022, China NMPA approved 14 new drugs, including 12 chemical drugs and 2 biological products.
Chemical drugs
1. 绿叶制药集团有限公司 's Toludesvenlafaxine Hydrochloride Sustained-release Tablets, 2. YL-Pharma's Linperlisib Tablets, 3. 天津红日药业股份有限公司 's p-Toluenesulfonamide Injection, 4. Vifor's Ferric Carboxymaltose Injection, 5. Lantheus ' Perflutren Lipid Microsphere Injection, 6. Mundipharma 's Oxycodone Hydrochloride and Naloxone Hydrochloride Dehydrate Prolonged-release Tablets, 7. Zhejiang Heze Kunyuan Pharma's Potassium Chloride Oral Solution, 8. Lepu Medical's Clopidogrel Bisulfate and Aspirin Tablets, 9. Sichuan Meida Kangjiale Pharma's Tirofiban Hydrochloride Injection, 10. CF PharmTech, Inc. 's Azelastine Hydrochloride and Fluticasone Propionate Nasal Spray, 11. Suzhou Xiehe Pharmaceutical Co., Ltd. 's Eliglustat Capsules, 12. Chimin Health Management's Sorbitol and Mannitol Irrigation Solution
Biological products
1. Shanghai Institute of Biological Products' Influenza Vaccine (Split Virion), 2. MSD 's Pembrolizumab Injection