The China Food and Drug Administration revised the Medical Device Supervision and Administration Regulations (MDR) and enforced it from June the 1st. As expected, this review, simplifies medical devices’ registration process, but some new regulations are in conflict with the new ones. A notice has been published about issues bound to paradoxes between the former […]
The Suzhou toxicology facility of WuXi PharmaTech obtained the statement of Good Laboratory Practice (GLP) from the Organization for Economic Cooperation and Development (OECD). The inspection was conducted by the Belgium GLP Monitorate. The inspection was made on 22 studies including toxicology, genetic toxicology, safety pharmacology, dermal irritation, skin phototoxicity, and immunology. Dr. Ge Li, […]
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 […]
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 […]
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 […]
The French biopharmaceutical company Immutep S.A and Eddingpharm started the production of their ImmuFact IMP321 product in WuXi AppTec facilities according to European, US and Chinese GMP standards. Immutep will technically support the development of the production of the anti-cancer drug and was, as well as Eddingpharm, very satisfied by the Chinese manufacture’s quality as […]
A large investment program is launched by the China’s National Health and Family Commission (NHFPC) to enhance drug development against cancer, cardiovascular and cerebrovascular diseases, neurodegenerative disorder, mental disorders, diabetes, autoimmune disease, drug resistant pathogen, tuberculosis and others. On the other hand, given to the still unmet medical needs of the Chinese population, the China […]
For 6 years, The Innovation Prize® has become increasingly successful at an International scale and became a reference in biotechnology. With the support of public organizations (The National Research Agency, The Pasteur Institute), the healthcare industry (Myriad Genetics, Ipsen, Servier and Pierre Fabre) and Universal Biotech, this prize awards biotechnology companies’ projects and academic research […]
Healthcare sector is one of the most active industries in terms of inbound M&A by foreign investors. With sales slowing in the West, the global drugs giants want a share of the booming profits in China. In particular, the biotechnology industry is part of the driving force behind this activity. China remains a compelling story […]
The Asia Pacific market is a vast underserved market. With three quarter of the Chinese and Indian populations considered as diabetic, nearly 200 million people may use self monitoring of blood glucose products. However no more than 45 percent of these patients have been diagnosed. Worst, inadequate education and awareness have led to a lack […]
In a current atmosphere of system’s reform aiming at turning over a whole new leaf and accentuated by the media’s spotlights focus on the recent investigations and crackdowns on companies in China. Thus, the healthcare industry will have to operate with tougher compliance risks and more frequent interaction with the Central government. Policies and procedures are changing […]
China’s biomedical sector is rapidly transforming itself from a manufacturing base to an innovation hub. First, the government is investing billions of dollars and setting up innovation centers in a bid to catch up with the western countries by the end of its 12th Five-Year Plan. Thus, the R&D investments, reaching a cumulative $160 billion last year […]
After the re-organization, the CFDA expanded its internal departments from 10 offices to 17, including the General Office, the Department of Policy, the Department of Legal Affairs, the Departments of Food Safety Supervision (I, II and III), the Department of Registration of Drugs and Cosmetics, the Department of Registration of Medical Devices, the Department of […]
China’s CFDA (China Food and Drug Administration) wants to boost the country’s innovative device industry. A response to new European legislation on medical devices. Recently the CFDA has released a draft, “Special Review and Approval Process for Innovative Medical Devices,” which makes the review and approval process for innovative devices more efficient. To define “innovative” […]
According to the CFDA : “On March 26, 2013, the secretariat of Tissue Engineered Medical Products Subcommittee of National Technical Committee on Implants for Surgery and Orthopedic Devices of Standardization Administration of China received the notification of the International Organization for Standardization (ISO), declaring that China has registered as a P-member of the ISO/TC150/SC7 (International […]
“Recently, China’s Chamber of Commerce for Import & Export of Medicines and Health Products analyzed the customs statistics of 2012. According to such statistics, the value of China’s import and export of medical device reached US$ 30.062 billion last year, increasing by 13.03%. The import value reached US$ 12.472 billion, increasing by 14.56% compared with […]
China’s 12th National People’s Congress has approved a plan to establish a ministry-level agency named China Food and Drug Administration (CFDA), which replaces the State Food and Drug Administration (SFDA). The agency has started a reorganization under the leadership of a new commissioner, Mr. Zhang Yong. Since March 22, 2013, SFDA replaced the sign on […]
“In order to better ensure the safety of medical devices, the State Food and Drug Administration (SFDA) organized the National Medical Electrical Equipment Standardization Technical Committee to complete the drafting of the industry standard for medical devices YY 0505-2012 “Medical electrical equipment—Part 1-2: General requirements for safety—Collateral standard: Electromagnetic compatibility—Requirements and tests (IEC 60601-1-2: 2004, […]
An aging population with unmet medical needs is driving the Chinese government to invest in the rapid development of innovative sensing technologies. China’s domestic Diagnostic Industry is still immature, with the current market structure dominated by Western companies and multinationals. However, emerging Chinese firms are gathering to challenge the Western players in the sensor and […]
The People’s Republic of China’s (PRC) National Development and Reform Commission has issud a “Consolidation Guidance”, on the 22nd of January 2013, aiming to accelerate consolidation within the pharmaceutical sector. The goals, to be achieved by 2015, set out by the Consolidation Guidance are : Combined Sales Revenues from the top 100 pharmaceutical companies in […]
Healthcare News Chinese Guideline to Forbid Doctors’ Incomes Linked to Medical Expenses (新华网, 2013-02-20) The Chinese government has released a guideline on its basic medicine system forbidding hospitals from linking doctors’ incomes with their patients’ medicine and medical exam expenses. In fact, in China some hospitals adjust doctors’ salary depending on the revenues earned through […]
The call for proposals Innovation Prize will be open from February 4 until April 15. NEW: You will have to fill in your letter of intent on the Open Innovation Management© platform. Our team will send you your personal username and password by email once you will have registered to the following form: APPLICATION FORM […]
The Chinese State Food and Drug Administration announced a reform plan concerning regulations. The SFDA is asking for public comments concerning the plan. The key strategic priorities expressed in the plan are: The will to accelerate technical reviews and regulatory approvals for innovative drugs. For this the SFDA has proposed to reward drug R&D capable […]
In a plan to regulate manufacturing and use of pharmaceutical excipients, Chinese State Food and Drug Administration will publish, by next month, a list defining which excipients must be licensed or require a Drug Master File (DMF) under new quality reglementations due to be introduced. These risk-based assessments will lead to a master list of […]
The State Food and Drug Administration (SFDA) announced that a Chinese institute has been designated to be a World Health Organization (WHO) Collaborating Center for the standardization and evaluation of biological products. “The designation will help China become a major player in biological product standardization and evaluation and boost the country’s global competitiveness in the […]
Universal Medica Group team wishes you the best for 2013!
To read the May edition articles : follow this link
The big chance to know investment and start-ups combined in China, especially Shanghai September 2-6, 2012, Shanghai, China. Shanghai International Business Incubator (SHIBI) International workshop is the premier event in the incubation industry in China, which has attracted more than 300 industry professionals from 20 countries and regions in the world attending it in the […]
About the Innovation Days 2012: The leading meeting in Paris for early-stage biotech sector! Innovation Days is designed to promote early-stage innovation biotech and to enable Pharma and investors in their business development & licensing efforts to source new platform technologies and innovative products. Key figures of 2012 edition: 450 attendees 50 + speakers with […]
Healthcare News Dehaier Medical Enters European Homecare Medical Product Market (Market Watch, 2011-12-16) Dehaier Medical Systems Ltd., an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, announced that it has signed on three Romanian companies to distribute Dehaier’s DHR-5L oxygen concentrators in Romania. This marks […]