+86 21 2215 7611 228 Weihai road • 16F Merchant Plaza • SHANGHAI 200041 • CHINA 

China to give up drug price regulation

Oct
19
2014

Drug price regulation has been an issue in terms of price quality and was a very hard move for global companies. The central government announced that a new regulation details will be published by July but the objective is already clear: free-market pricing for pharmaceuticals.
To Ms. Chen, partner and director of L.E.K Consulting, ‘it means the [commission] recognizes that forcing prices down and focusing purely on price does sacrifice drug safety, quality and availability’. Until now, the central government was encouraging provinces to reduce healthcare costs and prices to make healthcare services more affordable.

Source: The Wall Street Journal                                              Publication Date: 2014-05-19

Chinese scientists’ findings on the H7N9 virus

Oct
9
2014

A study published in the Nature Communication announced that Chinese scientist discovered in Hangzhou a human blood protein that would be associated with the H7N9 virus. Blood plasma levels of angiotensin II are higher in H7N9 patients and could be the root of physical deterioration.

According to Li Lanjuan, researcher at the Chinese Academy of Engineering and specialist in H7N9 prevention, this new finding may be a significant help in clinical practice and the executive editor of Nature Communication commented that ‘this study will provide a new perspective to H7N9 pathology and potential threatment for the future cases’.

Source: Shanghai Daily                                                                Publication Date: 2014-05-09

160 healthcare criminal gang members detained in Shanghai

Oct
21
2014

After seven months of investigation, Chinese authorities have arrested 160 members of a criminal gang in Shanghai for luring patients with overpriced drugs (10 times the original value). More than 500 victims were cheated through corrupt doctors for an amount reaching about CNY1.7.

On the other hand, 20 people have been arrested for selling more than 1.6 million fake Durex condoms and 19 detentions about counterfeit medical device in Henan province.

This large wave of ‘crack-downs’ is definitely highlighting the will of Xi Jinping’s government to drastly corruption and lures.

Source: Reuters                                                                     Publication date: 2014-04-21

Highlights of the CFDA Restructuring Plan

Oct
1
2013

After the re-organization, the CFDA expanded its internal departments from 10 offices to 17, including the General Office, the Department of Policy, the Department of Legal Affairs, the Departments of Food Safety Supervision (I, II and III), the Department of Registration of Drugs and Cosmetics, the Department of Registration of Medical Devices, the Department of Drug and Cosmetics Supervision, the Department of Medical Device Supervision, the Bureau of Investigation and Enforcement, the Department of Urgency Management, the Department of Technology and Standards, the Department of Communications, the Department of Human Resources, the Department of Planning and Finance, and the Department of International Cooperation (Office of Hong Kong, Macao and Taiwan Affairs). Notably, the Department of Food Safety Supervision increased from 1 to 3, in order to exercise oversight over the entire supply chain and strengthen the vigilance system.

 

The CFDA retrieved legislative authority concerning food and drug laws, as well as qualifying authority for the food safety testing institutions from the Ministry of Health. The agency also retrieved the certification authority for medical devices as well as the manufacturing approval authority and compulsory inspection authority concerning cosmetics from the General Administration of Quality Supervision, Inspection and Quarantine (the “AQSIQ”).

Some of the CFDA’s approval authorities are delegated to the provincial Food and Drug Administrations (the “Provincial FDAs”), including:

  • GMP certifications for drugs and medical devices,
  • Renewal of drug registrations and supplementary applications relating to drug registration (excluding those changes affecting product quality),
  • Application for change of registration (excluding those changes affecting product quality) for locally-produced Class III medical devices,
  • Drug contract manufacturing, and
  • Approvals related to imported non-special-use cosmetic products.

Source: www.lexology.com                                                                                                Publication Date: 2013-05-21

China Plans to Boost Innovative Medical Device Industry

Oct
1
2013

China’s CFDA (China Food and Drug Administration) wants to boost the country’s innovative device industry. A response to new European legislation on medical devices. Recently the CFDA has released a draft, “Special Review and Approval Process for Innovative Medical Devices,” which makes the review and approval process for innovative devices more efficient.

To define “innovative” as part of the eligibility requirements, “The primary functioning mechanism of the medical device shall be the first of its kind in China, and the device’s efficacy or safety profile shall be fundamentally improved as compared with other similar products.”

Apart from the efforts to improve the efficiency of the review and approval process for medical devices, the CFDA also intends to simplify the application materials required in the license re-registration process for medical devices.

Source: http://www.china-briefing.com/news/2013/05/03/china-to-boost-innovative-medical-device-industry.html?src=mddionline

Publication date: 2013-05-03

Import of Medical Devices in China Sees Rapid Growth

Oct
29
2013
“Recently, China’s Chamber of Commerce for Import & Export of Medicines and Health Products analyzed the customs statistics of 2012.   According to such statistics, the value of China’s import and export of medical device reached US$ 30.062 billion last year, increasing by 13.03%. The import value reached US$ 12.472 billion, increasing by 14.56% compared with the previous year.

Behind the growth, three features are notable:

1.         The import market is centralized.

China imported medical devices from over 100 countries during the last year, but, unsurprisingly, Europe and North America are the top two regions from which medical devices were imported into China.  Imports from Europe reached US $4.695 billion, representing 37.64% of the total imports, and imports from North America reached US $4 billion, representing 32.10% of the total imports.

2.         31 types of medical devices have import values exceeding US $100 million.

According to the statistics, the import values of 31 different types of medical devices, including, for instance, color ultrasonic diagnostic instruments, X-ray computed tomography apparatus and magnetic resonance imaging devices, exceeded US $100 million. The import value of orthopedic products has increased by 72.59%, representing the most rapid growth among all different types of medical devices.

3.         Shanghai has the largest share of the import market.

According to the statistics, 36.77% of the import value of medical devices is attributable to Shanghai, which has seen the largest import of medical devices in many years.  Among the importers in Shanghai last year, 69.51% of the companies are foreign invested.”

Source : www.insidemedicaldevices.com                           Publication Date : 2013-03-18