A U.S. China-focused newspaper says multinational drugmakers (MNCs) are fighting an uphill battle to survive in China, citing three types of problems with government regulations. China Business News said international drug companies cite problems with the China Food and Drug Administration (CFDA) as the main source of their concerns, adding the agency needs to be reformed in the way it regulates drugs. Other major issues, the publication said, are reimbursement and market access.
Ironically, many of the problems the MNCs cite are the result of China government reforms themselves, according to the report. The CFDA has become stricter in its review of drug applications, particularly in regards to quality.
The MNCs' main concern with the agency, the newspaper said, was operational inefficiency in reviewing approval applications, leading to long delays regardless of the past history in a company's performance.
Foreign drugmakers want the CFDA to give priority to companies with good records of past performance and capability instead of having their applications wait in long lines behind local drugmakers that may be notorious for failing to meet good standards and incapable of manufacturing quality products.
Another MNC complaint cited was a discouraging reimbursement system in China that tends to make foreign products less competitive in the country. That problem, the newspaper said, is caused by policies that allow hospitals to sell drugs at higher prices while discriminating against MNC medicines already subjected to price caps.
Finally, CBN said, MNC executives complain that the recent decline in the growth rate of China's pharmaceutical sector has them concerned about their investments in the country. Some already have switched their focus back to more reliable Western markets.
- here's the story from China Business News