China raising regulations over radioactive drugs

China is finessing oversight on radioactive pharmaceuticals. According to a joint notification by the National Medical Products Administration (NMPA) and State Administration of Science, Technology and Industry for National Defense, manufactures and operators of radioactive drugs will undergo a more rigorous regulatory process.

The companies that file for such matters in free trade zones (FTZs) in Chongqing, Fujian, Guangdong, Guangxi, Hainan, Hebei, Heilongjiang, Henan, Hubei, Jiangsu, Liaoning, Shaanxi, Shandong, Shanghai, Sichuan, Tianjin, Yunnan, or Zhejiang, will have to be checked and reviewed on the spot by the provincial medical products administrations (MPAs) and national defense local science and technology units. Those outside FTZs will submit filings to the provincial drug administrations, who will issue an examination opinion and report to the NMPA. Approved manufacturers will receive a permit from the provincial MPAs, valid for five years.

Radioactive drug manufacturing licenses and business licenses are printed by the NMPA, but processed by MPAs.


Related news
China plans new regulations on expanded clinical studies for medical devices, according to a draft proposal issued in a joint notification by the National Medical Products Administration (NMPA) and National Healthcare Commission (NHC).
China is revving up post-marketing management for medical devices.
China’s National Medical Products Administration (NMPA) released a notification in relation to basic data tracking for the Market Authorization Holder (MAH) system.
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA:600196; HKG:02196) subsidiary Shanghai Henlius Pharmaceutical Co., Ltd (HKG.02696) announced a clinical trial filing for its anti-receptor activator of NF-КB ligand (RANKL) monoclonal antibody (mAb) HLX14.
The National Medical Products Administration (NMPA) released a draft proposal in relation to drug filing and data management, soliciting public feedback until March 15.
Recent news
The National Medical Products Administration (NMPA) last week revealed that Celgene’s Abraxane (paclitaxel, albumin bound) would lose its import clearance after agency inspectors uncovered manufacturing issues at the Fresenius Kabi plant responsible for manufacturing the drug. The news impacts Chinese biotech BeiGene Inc., which generated around USD 100 million with Abraxane in China as the drug's marketing agent under license from Celgene.
  • 1585666816337
  • China
Pfizer subsidiary Wyeth this week obtained a marketing approval from Brazil's National Health Surveillance Agency (ANVISA) for its iron replacement therapy Monofer (ferric derisomaltose), as GBI analysis shows.
Hugo Sigman, founder of of Argentina-based group Insud Pharma, last week commented on Argentina’s biopharmaceutical industry as the COVID-19 pandemic puts the health sector to test.
China-based Shanghai Fosun Pharmaceutical (Group) Co., Ltd (SHA:600196; HKG:02196) released its Q4 2019 financial report.
According to GBI analysis, Mexico’s Federal Commission for the Protection against Health Risks (COFEPRIS) has published recent market approvals for Swiss major Novartis subsidiary Sandoz’s Arasamila (rituximab), Japan-based Daiichi Sankyo’s factor Xa (FXa) inhibitor Lixiana (edoxaban), and compatriot Takeda branch Baxalta’s antihemophilic Adynovate (rurioctocog alfa pegol).
GoBroad Healthcare Group broke ground on construction of a research hospital in Beijing’s Future Science Park this week.
Analytics Snapshot

Analytics Snapshot