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 MDR and update one in which three points are clarified: manufacturers should rely on ‘currently effective provision’ as long as the new rules are not totally validated and effective and medical registrations issued after June 1st have a five year license term (vs 4 with the revised MDR); class II and III devices manufacturers and distributors will follow the current ‘administrative rules and guidance documents’; in case of illegal actions committed before June 1st, penalties will rely on the former MDR.
Source: National Law Forum Date of Publication: 2014-07-03
WuXi PharmaTech gains the OECD’s certification
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, CEO of the company, said ‘with this recognition, WuXi has further solidified its leadership in offering the highest-quality toxicology service in China’.
Source: TrueblueTribune Publication Date: 2014-05-30
WuXi PharmaTech manufactures ImmuFact IMP321
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 Dr. Triebel, Medical Director of Immutep said: ‘We have been very impressed by WuXi’s know how and motivation’.
Source: First Word Pharma Publication Date: 2014-04-11
China investing USD3.2 billion in drug development program and speeding up approvals
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 Food & Drug Administration is speeding up innovative medical device approvals by creating a specific unique division. The objective is to shorten the whole approval process to 160 days.
Source: Seeking Alpha Publication Date: 2014-03-28
Call for Proposal for The Innovation Prize 2014
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 teams in life sciences.
The fields concerned are drugs, medical devices, medical technologies and e-health solutions.
Each year, 120 candidates apply from 25 countries to win the overall prize of 50.000 € including cash and consulting services provided by Universal Biotech and its partners.
The call for proposal of the Innovation Prize 2014 will be launched on February 3rd, 2014. The candidates will be able to register on the dedicated online platform: www.universal-biotech-prize.com
This key event for innovation projects is a real springboard for your cluster, institution, university… It is an international showcase for companies and innovative projects in the field of biotechnology.
The call for proposal will be launched on February 2014 but feel free to contact us now to relay information on your communication supports and to exchange logos and visuals so we can give you maximum visibility on our website.
China healthcare sector among the most active industries in terms of investment opportunities
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 for global firms in the hunt for investment opportunities. As China’s global economy has moved to center stage, these opportunities have expanded into new sectors and new technologies. Among them pharmaceuticals and biotechnologies are driving the shift. They lead the increasing number of foreign interest and investors, and keep on developing new ranges of perspectives on the China inbound M&A market.
The Chinese government is specifically encouraging private investment in the medical industry. Taken together, these elements provide ample opportunities for cross-border integration of the pharmaceutical and health care industry. China is willing to keep on increasing domestic and foreign investments in healthcare services as part of restructuring the service sector.
Moreover, the value of mergers and acquisitions in China’s healthcare industry grew by 35% year over year to USD 7.4 billion in the first 8 months of 2013, according to Dealogic figures. The number of mergers and acquisitions rose by 8% during the same period to reach 178. In particular, USD 1.1 billion worth of deals involved American firms targeting Chinese healthcare firms.
Source: http://www.bbc.co.uk Publication Date: 2013-09-06
Diabetes & Digital in Emerging Markets
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 of use of self monitoring in the region, with less than 10 percent of the diabetic population using it.
As a consequence, the market is expected to reach $358.70 million in 2017 thanks to the development by equipment manufacturer, governmental and non-governmental organizations, and hospitals of camps and drives to awareness among patients.
In particular, regarding the China Diabetes market, it has been forecasted to expand by 20% annually to reach a value of around USD 3.2 billion by 2016, spurred by guidelines that set higher treatment standards. The rapid economic development has brought mass urbanization, changing diets and increasingly sedentary lifestyles. China has already the largest number of people with diabetes compared to any other country, with around 92.3 million adults suffering from the disease in 2013. Thus it represents a crucial issue for the central government as well as a booming market for pharma companies.
In deed, diabetes has become a rapidly growing public health problem in China over the past 20 years. Recently many pharma companies are deeply committing to developing a diverse range of innovative products for the growing type 2 diabètes population.
Source: http://www.biospectrumasia.com Publication Date: 2013-07-23
How to comply with new standard requierements in China?
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 in order to be simplified and more transparent, leading Big Pharmas and the other healthcare actors implement programs to ensure they will respect these and upgrade their activity processes to comply with the new regulations.
Among the main actions to implement and deal with the new standards, companies will first have to prepare a training courses for employees on how to handle investigations; they will also need to conduct compliance and legal risk assessment; financial and accounting practices have to be reviewed with internal control procedures; companies must conduct proactive internal audits and investigate on suspected violations, as well as detailed due diligence on third party intermediaries such as agents and sales representatives;
Globally, the current situation requires from every company to be able to take prompt action if faced with evidence or allegations of wrongdoing.
Chinese government authorities’ actions have led to new behavior requirements that can be reached only through compliant structural improvement.
Source: www.mondaq.com Publication Date: 2013-08-01
China’s biomedical sector transforming itself into an innovation hub
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 and close to surpassing Japan’s spending, are starting to pay off.
Moreover, the exponential increases in pharmaceutical related patent filings are catapulting the Asian giant over the U.S. and Japan. Also, the country’s five major provinces have formed “super clusters” thanks to the remarkable pace of establishment of 15 new drug innovation centers.
In particular, China’s biomedical sector is relying on sustained investment as its booster to rapid growth. The Major New Drug Innovation Program (MNDIP) has emerged as its main source of innovation since 2009 with a special focus on cancer, the leading cause of death in China. Timely changes in patent and related laws, since the nation joined the Trade-Related aspects of Intellectual Property rights (TRIPS) agreement in 1992, have also contributed to this growth.
Source: www.usa.chinadaily.com.cn Publication Date: 2013-08-08
China got ISO/TC150/SC7 Voting Rights
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 Organization for Standardization/ Technical Committee 150 for Implants for Surgery/ Sub Committee 7 for Tissue Engineered Medical Products) and obtained the ISO/TC150/SC7 voting rights”
Source : http://eng.sfda.gov.cn/WS03/CL0757/79617.html Publication Date : 2013-04-08
China Food and Drug Administration (CFDA) replaces the State Food and Drug Administration (SFDA)
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 its headquarters with a new sign that has its new name in Chinese, and also began displaying the new name on the agency’s official Chinese and English websites, showing “China Food and Drug Administration” as its English name. The agency has announced that all of the previous functions of the SFDA have been merged into the new CFDA.
As a result of this restructuring, CFDA will be a full ministry agency reporting directly to the State Council, which is China’s highest administrative body.
This new development seeks “to strengthen regulation and boost people’s confidence in the country’s food and drug products” by eliminating “blind spots” and overlaps in regulatory authority, according to a Chinese official.
The Chinese government has also stated that this change will help to promote regulatory oversight and identify responsible parties, especially with respect to the regulation of food, which has been undertaken by SFDA and several other government ministries and agencies.
The newly elevated and expanded CFDA will integrate the functions of various agencies that regulate food, while also keeping its authority over drugs, devices, and cosmetics. At present, the primary focus has been on the consolidated regulation of food products, so the impact of these structural changes on the regulation of medical devices in China is unclear. Companies whose products are regulated by the agency should closely monitor the developments.
Source : http://www.sfda.gov.cn/WS01/CL0051/79254.html Publication Date : 2013-03-22
SFDA : Electromagnetic compatibility standard medical electrical equipment issued
“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, IDT)”. The Standard was issued on December 17, 2012 and will be put into practice as of January 1, 2014. As a basic general safety standard which is parallel with GB 9706.1 “Medical electrical equipment—Part 1: General requirements for safety”, YY 0505-2012 is a mandatory industry standard for medical electric equipment.”
Source : www.sfda.gov.cn Publication date : 2013-03-14
$183 Million Funding Destined to Transform China’s Diagnostic Market
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 diagnostic market, according to Lux Research.
In fact, the government is planning to jump start a homegrown industry, with stated goals in the 12th Five Year Plan (FYP) to improve overall healthcare, especially in rural areas, and increase fundings in a number of key sensing and diagnostic research areas. In the 2011-2012 funding period, $82.9 million was distributed in molecular, biochemical, immunological, and physical diagnostic spaces, and China will aldo spend an additional $103 million on basic research in the sector during the 12th FYP.
In other words, Chinese domestic companies are switching strateg from a “me-too,” go-to-market strategy based on low cost production, to novel solutions requiring long R&D cycles.
In the $1.5 billion Chinese medical imaging market, Mindray, Wandong, and Neusoft have a rising market share of 10% based on sophisticated product development strategies.
Moreover the Beijing Genomics Institute, which is claimed to be the world’s largest genome sequencing organization, is eyeing a big payoff by developing drugs specifically designed for Chinese and non-Caucasian populations, filling a gap left by U.S. drugmakers, based on recognizing differences in response to marketed drugs between different populations.
University research in China is finding its way into the business value chain. Beijing Largev Instrumentation, a developer of dental CT, was founded by Tsinghua University and Nuctech, and is a major player funded under the “key technologies and product development of major digital medical equipment” mandate for the 12th FYP (Five Year Plan).
Source : www.businesswire.com Publication date : 2013-03-05
Consolidation Guidance for Pharmaceutical Companies
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 China should account for more than half of the total PRC pharmaceutical sector sales revenue.
- The top 20 pharmaceutical companies in China, selling “Essential Pharmaceuticals”, which are mostly generic pharmaceuticals listed in the Essential Drugs list published by the MoH (Ministry of Health) and are subject to price regulations, should account for 80% of all “Essential Pharmaceutical” sales in China.
Source : www.mondaq.com Publication Date : 2013-02-28
Call for Proposals – Innovation Prize 2013
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
Should you have any questions, do not hesitate to contact us using this e-mail: email@example.com
SFDA Unveils Regulatory Reform Plan
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 of delivering better therapeutic effects on critical diseases. The reward results in indigenous intellectual property by accelerated technical reviews and regulatory approvals for the resulting innovative drugs. Moreover, innovative drugs whose R&D is sponsored by the Chinese government will be treated with high priority in technical reviews. Pre-clinical studies for innovative drugs were also mentioned, stating they should be risk-based ant that their technical evaluation should aim for a higher level of control of the quality risks. The SFDA might outsource pre-clinical studies’ technical review. They will also consider allowing the transfer of clinical trial authorizations.
- Technical reviews and regulatory approvals for high priority generics are also to be accelerated. In fact, the SFDA is going to define an evaluation mechanism for marketed generic drugs. “Generic drugs which fail to demonstrate sufficient clinical values will be discouraged from further development and manufacturing”. Generics which have a shortage in supply, insufficient competition, limited patient access and affordability, an indication for pediatric, rare or special diseases and have been evaluated as urgently required for clinical use will therefor receive high priority in technical reviews and regulatory approvals. “The quality consistency evaluation for generics will be a major policy initiative in the next couple of years and will lead to the formation of a Chinese Orange Book.” According to Mondaq.
- Clinical studies’ quality control will be improved “SFDA will establish an information disclosure mechanism to enhance transparency of clinical studies and raise public awareness of the notion of, and need for, clinical studies.”
- To boost development and manufacturing of pediatric drugs.
Source : www.mondaq.com Publication Date : 2013-01-14
SFDA to Publish Excipient List for GMP
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 excipients requiring different levels of regulatory supervision.
“Provinicial SFDA will conduct on-site inspections and random tests according to Excipients GMP (good manufacturing practice).”
The list will specify which registration documents manufacturers will need.
Source : www.in-pharmatechnologist.com Publication Date : 2013-01-22
Chinese Institute designed WHO collaborating center for biological products
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 research and development of biotechnology,” said Wang Junzhi, director of the IBPC (Institute for Biological Product Control). In fact, the IBPC belongs to the National Institutes for Food and Drug Control (NIFDC) in China, it is the first WHO Collaborating Center for the standardization and evaluation of biological products located in an emerging country, and is the seventh in the world, according to the SFDA.
The WHO official website indicates that the work plan includes a various amount of activities that will contribute to the development of international standards for vaccines and other biological products, and also help their implementation into regulatory practice. Moreover, the initial period of designation is four years.
Source : www.xinhuanet.com – Publication date : 2013-01-17
Newsletter : Lifescience e-novation
To read the May edition articles : follow this link
15th International Workshop on Business Incubation
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 past 14 years.
The one-week workshop features keynote speech, incubator tours and networking opportunities.
• China’s innovation and entrepreneurship system
• The innovation and entrepreneurial environment in Shanghai
• Entrepreneurial pre-incubation promotes higher entrepreneurship success rate
• Innovative practice of technological finance in the entrepreneurship
• Developing way of business incubator combined by incubation and capital
• Construction of professional incubation service system
• Presentation and matchmaking with excellent start-ups in Shanghai.
To register, please click here: http://www.ypbase.com/Application.html
Innovation Days 2012
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 conferences, workshops and presentations
- 40 + exhibitors at the exhibition hall and the Innovation Gallery
- 800 partnering meetings
Download the post event report.