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Beijing, China
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News Article | April 21, 2017
Site: www.PR.com

WiCON Announces Upcoming Publication of China Pharmaceutical Guide 2017 (12th Edition) - The Chinese pharmaceutical market rose slower in 2016 at only 8.3% to CNY 1,497.5 billion at retail price level, compared with 11.0% in 2015, according to the China Pharmaceutical Guide 2017 (12th Edition), which is to be published in August 2017, and WiCON | Pharma China (www.pharmachinaonline.com) quoting official SMEI data. Princeton, NJ, April 21, 2017 --( On the other hand, CPIIC data suggests the Chinese pharmaceutical industry revenue and profit growth rebounded slightly in 2016 to 10.3% and 15.6% respectively, despite shadows of numerous challenges stemmed from the troubled Chinese economy, regulatory shakeups, cost containment measures and healthcare reform turbulences. Albeit the seemingly better industry performance, which may simply mean higher inventory in the face of slower market growth, the era of single-digit Chinese pharmaceutical market growth is here to stay, the China Pharmaceutical Guide 2017 summarizes. QuintilesIMS reported Chinese hospital drug sales were up 8.1% in 2016. The slowing growth was attributed by the company to be intensified government cost containment policies, implementation of rationalization policies for clinical drug consumption, control of drug sales share in total hospital revenues, and centralized hospital tender purchase. It also disclosed the sales of OTC drugs and health foods of Chinese retail pharmacy sector to have reached CNY 77.4 billion in 2016, up only 2.8%, continuing a slowing growth trend due to slower price rise and negative volume growth. The China Pharmaceutical Guide 2017, an indispensable reference for MNC pharma executives with China responsibilities for more than a decade, provides various data sets on the Chinese pharmaceutical market and drug consumption patterns from respected sources including QuintilesIMS, SMEI, CPIIC, CPA, Sinohealth, Nicholas Hall and other official sources. The publication, from the publisher of WiCON | Pharma China covers all aspects of the Chinese pharma/healthcare sector, aims to help HQ and local executives at proactive MNCs feel the dynamic and up-to-date pulse of Chinese healthcare in order to stay in the driver seat of their business in the country. In 2016 and early 2017, the CFDA’s move to elevate drug quality and reform drug approval system, though contradicted by other government agency’s preoccupation to slash drug costs, has advanced substantially in the past year. The real questions are that, with the world’s largest population, what kind of healthcare solution and product mix China can and should get for merely 5%-6% of GDP? Is the country willing or able to pay more for better drugs and healthcare being pushed? Despite superficial slogans and touted ambitions of the Chinese government, healthcare reform has been hijacked by cost containment and gone astray from the pledged path of improving efficiency and fixing structural flaws. With tax and other revenues drying up and under increasing threat of BMI system deficit amid a slowing Chinese economy, local governments are pressured by both the central government and the public to do more for healthcare with less financial resources. Pushed to the corner, the Chinese pharmaceutical industry is now at the brink of business bottomlines. Nonetheless, many drug company executives are still bullish about China's long-term growth prospects. As the government improves access to healthcare, the country’s pharmaceutical market is projected by QuintilesIMS to reach approximately between $140 billion and $170 billion by 2021 on slower annual growth between 5% and 8%. But the short-term picture is proving difficult, with reforms in the hospital sector affecting physician prescriptions and price pressures growing for most drugs. The Chinese economy and the reform of its healthcare system are once again at crossroads. Pharma companies, local or foreign, must change to remain competitive and fit with the market. Other than growing challenges on the ground in China, there are success stories from all categories of players, whether they are foreign or local, large or small, newcomer or established, private or state-owned. However, to be one of the success stories require a thorough understanding of the sector, ability to face and tackle challenges, flexibility to deal with changes, and skills to maneuver through complex situations. Now in its 12th edition, the China Pharmaceutical Guide 2017 continues to play an instrumental role in helping executives understand, navigate, manage and lead their pharmaceutical businesses in China. - Authored by James J. Shen, a veteran pharmaceutical executive and the Publisher/Chief Editor of Pharma China who has three decades of managing China and Asian pharma businesses as a leading China business consultant, multinational company executive and an entrepreneur. - Prepared for the real world executives to help them navigate through the complex and turbulent Chinese healthcare business environment for success. - Comprehensive and latest data on the Chinese pharmaceutical industry and market, the Chinese healthcare sector, drug evaluation and registration, and disease & drug consumption patterns – much of the data made available exclusively by reputable sources to China Pharmaceutical Guide and Pharma China. The China Pharmaceutical Guide 2017 (12th Edition) has been completely reorganized into four volumes: - Volume I: Overview of the Chinese Pharmaceutical & Healthcare Sectors (up-to-date coverage of China’s business environment, history and structure of the Chinese pharmaceutical industry, Chinese health sector structure and statistics, health insurance sector structure and data, as well as disease and drug consumption patterns); - Volume II: Chinese Pharmaceutical IP and Regulatory Guide (a complete and clear picture of the Chinese drug regulatory and IP framework is presented with thorough summaries covering all regulations in drug/biologic registration, drug pricing, research/GLP, clinical research/GCP, import and export, manufacture/GMP, packaging, distribution/GSP, OTC/ethical drug classification, drug advertising, adverse drug reaction monitoring, internet drug sales/e-commerce, physician drug prescription codes, contract manufacturing, international regulatory harmonization, compulsory licensing/technology transfer, patent and trademark application, enforcement, litigation and strategies, data exclusivity, counterfeit drugs and drug safety liabilities. Summaries of regulations are provided with needed analysis. In addition, a thorough introduction of all drug related government agencies and industry associations is given with their functions analyzed. - Volume III: Annual Review, Trends, Opportunities and Strategic Considerations (including a complete review of latest data, business trends, regulatory & IP/legal developments and healthcare reform progress of the Chinese pharmaceutical industry and market in 2016/1H2017, and a large collection of feature articles from industry experts relating to contemporary trends, issues and strategic considerations as well as promising opportunities of the present and future); and - Volume IV: Sales & Marketing, Entry Strategies and Case Studies (covering orientation, models and strategies of pharmaceutical sales, marketing and distribution in China, marketing entry strategies and execution, case studies featuring success stories of MNCs and domestic players, R&D and outsourcing, human resource management and legal/IP issues), as well as appendices with full texts of important healthcare/pharmaceutical related policies, laws and regulations. The China Pharmaceutical Guide 2017 (12th Edition), which will be published in early August 2017, had been thoroughly updated with ample latest data from many reputable sources, abundant analysis by leading industry experts, new regulations and more case studies. Its coverage was renewed and expanded in the following areas: - Hundreds of pages of new data, information, analysis and case studies. - Thorough summaries and analysis of the latest healthcare reform, drug pricing & reimbursement and hospital tender purchase policies. - Comprehensive industry, market and international trade data as well as health statistics are updated with the 2016 (full year) and available figures for the first half of 2017. - Expanded coverage on e-commerce and digital marketing opportunities, the primary healthcare sector, the OTC and consumer healthcare sector, high growth market segments, key regional hospital markets, and the pharmaceutical distribution sector, - Updated coverage of the Chinese biosimilars/biologics market prospects and regulatory outlook. - Updated coverage of emerging legal issues (including latest Chinese government crackdown on corruption in healthcare, FCPA/compliance and liability issues) and drug-related IP and trademark concerns. - Comprehensive top line data, research findings and observations from our collaborative partners such as IMS Health, Kantar Health, Nicholas Hall, ZS Associates, Rubicon Strategy Group and RDPAC, as well as other reputable sources including the Chinese Pharmaceutical Association, SMEI, CPIIC and Sinohealth. - All regulatory changes in 2016/1H2017 are updated to present a clear and most up-to-date picture of the Chinese drug regulatory framework with summaries and analysis of all pharmaceutical related regulations in effect by mid-2017. - Focused coverage of China’s ongoing efforts to revamp its drug regulatory regime through amendments of the Drug Administration Law, its latest proposal and preparations to overhaul the drug pricing mechanism, deepening reform of its drug registration and evaluation regime, new policies to support drug innovation and high clinical value generics, and its initiative to re-evaluate all generic drugs with bioequivalence studies. - An updated section covering proposed new drug-related laws and regulations under drafting process with selective previews of the draft versions. - Extensive review and analysis of China’s drug registration applications and approvals as well as Chinese drug innovation trends in recent years. - Comprehensive review of Sino-foreign M&A, joint venture, strategic alliance, licensing, research partnerships, co-marketing, and new drug research events in 2016 and early 2017. - Expanded coverage on MNC strategies in China with healthcare reform in the backdrop, intellectual property/patent law amendments, data exclusivity, patent litigation, drug regulations, pharma marketing and distribution strategies, drug consumption patterns, the Chinese R&D and outsourcing sector, clinical studies/practices, healthcare reform, community healthcare sector, essential drug policy, regional drug consumption patterns, and the vaccine and API sectors. - Numerous new case studies in five key areas of pharma business are added. All purchasers of the China Pharmaceutical Guide 2017 (12th Edition) will receive a one-year complimentary subscription of Pharma China Weekly e-Alert (Premium Edition) which provides a weekly summary of the top Chinese pharmaceutical news and Breaking News Alerts which notifies subscribers of any major unfolding events in the Chinese pharmaceutical and healthcare sectors. For further information, please contact WiCON International Group to request a free promotional PDF containing the executive summary, the table of contents, the lists of tables and charts, and preface. To download our promotional PDF and a brochure/order form, please visit: http://www.pharmachinaonline.com/download/index.asp. WiCON International Group LLC Tel: +86 10 84476010 Fax: +86 10 84476110 or +1 801 7515728 Email: info@pharmachinaonline.com ­WiCON International Group is the publisher of WiCON|Pharma China (www.pharmachinaonline.com), the most trusted English media and source of business intelligence covering the Chinese pharmaceutical / biopharmaceutical sector. WiCON|Pharma China caters for the growing needs of the global pharma industry for up-to-date and insightful intelligence on China’s burgeoning but increasingly complex healthcare marketplace. It is subscribed by most MNCs, leading CROs, investment banks, consulting firms and industry associations. WiCON | Pharma China publishes the following products: - Pharma China Journal Edition (monthly in PDF and Print) - Pharma China Web Edition (continuously-updated news and in-depth commentaries) - China Pharmaceutical Guide (the most comprehensive and authoritative reference for China’s healthcare sector) Princeton, NJ, April 21, 2017 --( PR.com )-- The Chinese pharmaceutical market rose slower in 2016 at only 8.3% to CNY 1,497.5 billion at retail price level, compared with 11.0% in 2015, according to the China Pharmaceutical Guide 2017 (12th Edition), which is to be published in August 2017, and WiCON | Pharma China (www.pharmachinaonline.com) quoting official SMEI data.On the other hand, CPIIC data suggests the Chinese pharmaceutical industry revenue and profit growth rebounded slightly in 2016 to 10.3% and 15.6% respectively, despite shadows of numerous challenges stemmed from the troubled Chinese economy, regulatory shakeups, cost containment measures and healthcare reform turbulences.Albeit the seemingly better industry performance, which may simply mean higher inventory in the face of slower market growth, the era of single-digit Chinese pharmaceutical market growth is here to stay, the China Pharmaceutical Guide 2017 summarizes.QuintilesIMS reported Chinese hospital drug sales were up 8.1% in 2016. The slowing growth was attributed by the company to be intensified government cost containment policies, implementation of rationalization policies for clinical drug consumption, control of drug sales share in total hospital revenues, and centralized hospital tender purchase. It also disclosed the sales of OTC drugs and health foods of Chinese retail pharmacy sector to have reached CNY 77.4 billion in 2016, up only 2.8%, continuing a slowing growth trend due to slower price rise and negative volume growth.The China Pharmaceutical Guide 2017, an indispensable reference for MNC pharma executives with China responsibilities for more than a decade, provides various data sets on the Chinese pharmaceutical market and drug consumption patterns from respected sources including QuintilesIMS, SMEI, CPIIC, CPA, Sinohealth, Nicholas Hall and other official sources. The publication, from the publisher of WiCON | Pharma China covers all aspects of the Chinese pharma/healthcare sector, aims to help HQ and local executives at proactive MNCs feel the dynamic and up-to-date pulse of Chinese healthcare in order to stay in the driver seat of their business in the country.In 2016 and early 2017, the CFDA’s move to elevate drug quality and reform drug approval system, though contradicted by other government agency’s preoccupation to slash drug costs, has advanced substantially in the past year. The real questions are that, with the world’s largest population, what kind of healthcare solution and product mix China can and should get for merely 5%-6% of GDP? Is the country willing or able to pay more for better drugs and healthcare being pushed?Despite superficial slogans and touted ambitions of the Chinese government, healthcare reform has been hijacked by cost containment and gone astray from the pledged path of improving efficiency and fixing structural flaws. With tax and other revenues drying up and under increasing threat of BMI system deficit amid a slowing Chinese economy, local governments are pressured by both the central government and the public to do more for healthcare with less financial resources.Pushed to the corner, the Chinese pharmaceutical industry is now at the brink of business bottomlines. Nonetheless, many drug company executives are still bullish about China's long-term growth prospects. As the government improves access to healthcare, the country’s pharmaceutical market is projected by QuintilesIMS to reach approximately between $140 billion and $170 billion by 2021 on slower annual growth between 5% and 8%. But the short-term picture is proving difficult, with reforms in the hospital sector affecting physician prescriptions and price pressures growing for most drugs.The Chinese economy and the reform of its healthcare system are once again at crossroads. Pharma companies, local or foreign, must change to remain competitive and fit with the market.Other than growing challenges on the ground in China, there are success stories from all categories of players, whether they are foreign or local, large or small, newcomer or established, private or state-owned. However, to be one of the success stories require a thorough understanding of the sector, ability to face and tackle challenges, flexibility to deal with changes, and skills to maneuver through complex situations.Now in its 12th edition, the China Pharmaceutical Guide 2017 continues to play an instrumental role in helping executives understand, navigate, manage and lead their pharmaceutical businesses in China.- Authored by James J. Shen, a veteran pharmaceutical executive and the Publisher/Chief Editor of Pharma China who has three decades of managing China and Asian pharma businesses as a leading China business consultant, multinational company executive and an entrepreneur.- Prepared for the real world executives to help them navigate through the complex and turbulent Chinese healthcare business environment for success.- Comprehensive and latest data on the Chinese pharmaceutical industry and market, the Chinese healthcare sector, drug evaluation and registration, and disease & drug consumption patterns – much of the data made available exclusively by reputable sources to China Pharmaceutical Guide and Pharma China.The China Pharmaceutical Guide 2017 (12th Edition) has been completely reorganized into four volumes:- Volume I: Overview of the Chinese Pharmaceutical & Healthcare Sectors (up-to-date coverage of China’s business environment, history and structure of the Chinese pharmaceutical industry, Chinese health sector structure and statistics, health insurance sector structure and data, as well as disease and drug consumption patterns);- Volume II: Chinese Pharmaceutical IP and Regulatory Guide (a complete and clear picture of the Chinese drug regulatory and IP framework is presented with thorough summaries covering all regulations in drug/biologic registration, drug pricing, research/GLP, clinical research/GCP, import and export, manufacture/GMP, packaging, distribution/GSP, OTC/ethical drug classification, drug advertising, adverse drug reaction monitoring, internet drug sales/e-commerce, physician drug prescription codes, contract manufacturing, international regulatory harmonization, compulsory licensing/technology transfer, patent and trademark application, enforcement, litigation and strategies, data exclusivity, counterfeit drugs and drug safety liabilities. Summaries of regulations are provided with needed analysis. In addition, a thorough introduction of all drug related government agencies and industry associations is given with their functions analyzed.- Volume III: Annual Review, Trends, Opportunities and Strategic Considerations (including a complete review of latest data, business trends, regulatory & IP/legal developments and healthcare reform progress of the Chinese pharmaceutical industry and market in 2016/1H2017, and a large collection of feature articles from industry experts relating to contemporary trends, issues and strategic considerations as well as promising opportunities of the present and future); and- Volume IV: Sales & Marketing, Entry Strategies and Case Studies (covering orientation, models and strategies of pharmaceutical sales, marketing and distribution in China, marketing entry strategies and execution, case studies featuring success stories of MNCs and domestic players, R&D and outsourcing, human resource management and legal/IP issues), as well as appendices with full texts of important healthcare/pharmaceutical related policies, laws and regulations.The China Pharmaceutical Guide 2017 (12th Edition), which will be published in early August 2017, had been thoroughly updated with ample latest data from many reputable sources, abundant analysis by leading industry experts, new regulations and more case studies. Its coverage was renewed and expanded in the following areas:- Hundreds of pages of new data, information, analysis and case studies.- Thorough summaries and analysis of the latest healthcare reform, drug pricing & reimbursement and hospital tender purchase policies.- Comprehensive industry, market and international trade data as well as health statistics are updated with the 2016 (full year) and available figures for the first half of 2017.- Expanded coverage on e-commerce and digital marketing opportunities, the primary healthcare sector, the OTC and consumer healthcare sector, high growth market segments, key regional hospital markets, and the pharmaceutical distribution sector,- Updated coverage of the Chinese biosimilars/biologics market prospects and regulatory outlook.- Updated coverage of emerging legal issues (including latest Chinese government crackdown on corruption in healthcare, FCPA/compliance and liability issues) and drug-related IP and trademark concerns.- Comprehensive top line data, research findings and observations from our collaborative partners such as IMS Health, Kantar Health, Nicholas Hall, ZS Associates, Rubicon Strategy Group and RDPAC, as well as other reputable sources including the Chinese Pharmaceutical Association, SMEI, CPIIC and Sinohealth.- All regulatory changes in 2016/1H2017 are updated to present a clear and most up-to-date picture of the Chinese drug regulatory framework with summaries and analysis of all pharmaceutical related regulations in effect by mid-2017.- Focused coverage of China’s ongoing efforts to revamp its drug regulatory regime through amendments of the Drug Administration Law, its latest proposal and preparations to overhaul the drug pricing mechanism, deepening reform of its drug registration and evaluation regime, new policies to support drug innovation and high clinical value generics, and its initiative to re-evaluate all generic drugs with bioequivalence studies.- An updated section covering proposed new drug-related laws and regulations under drafting process with selective previews of the draft versions.- Extensive review and analysis of China’s drug registration applications and approvals as well as Chinese drug innovation trends in recent years.- Comprehensive review of Sino-foreign M&A, joint venture, strategic alliance, licensing, research partnerships, co-marketing, and new drug research events in 2016 and early 2017.- Expanded coverage on MNC strategies in China with healthcare reform in the backdrop, intellectual property/patent law amendments, data exclusivity, patent litigation, drug regulations, pharma marketing and distribution strategies, drug consumption patterns, the Chinese R&D and outsourcing sector, clinical studies/practices, healthcare reform, community healthcare sector, essential drug policy, regional drug consumption patterns, and the vaccine and API sectors.- Numerous new case studies in five key areas of pharma business are added.All purchasers of the China Pharmaceutical Guide 2017 (12th Edition) will receive a one-year complimentary subscription of Pharma China Weekly e-Alert (Premium Edition) which provides a weekly summary of the top Chinese pharmaceutical news and Breaking News Alerts which notifies subscribers of any major unfolding events in the Chinese pharmaceutical and healthcare sectors.For further information, please contact WiCON International Group to request a free promotional PDF containing the executive summary, the table of contents, the lists of tables and charts, and preface. To download our promotional PDF and a brochure/order form, please visit:http://www.pharmachinaonline.com/download/index.asp.WiCON International Group LLCTel: +86 10 84476010 Fax: +86 10 84476110 or +1 801 7515728Email: info@pharmachinaonline.com­WiCON International Group is the publisher of WiCON|Pharma China (www.pharmachinaonline.com), the most trusted English media and source of business intelligence covering the Chinese pharmaceutical / biopharmaceutical sector.WiCON|Pharma China caters for the growing needs of the global pharma industry for up-to-date and insightful intelligence on China’s burgeoning but increasingly complex healthcare marketplace. It is subscribed by most MNCs, leading CROs, investment banks, consulting firms and industry associations.WiCON | Pharma China publishes the following products:- Pharma China Journal Edition (monthly in PDF and Print)- Pharma China Web Edition (continuously-updated news and in-depth commentaries)- China Pharmaceutical Guide (the most comprehensive and authoritative reference for China’s healthcare sector) WiCON Announces Upcoming Publication of China Pharmaceutical Guide 2017 (12th Edition) The Chinese pharmaceutical market rose slower in 2016 at only 8.3% to CNY 1,497.5 billion at retail price level, compared with 11.0% in 2015, according to the China Pharmaceutical Guide 2017 (12th Edition), which is to be published in August 2017, and WiCON | Pharma China (www.pharmachinaonline.com) Filename: ChinaPharmaceuticalGuide2017.pdf Click here to view the list of recent Press Releases from Wicon International Group LLC


Pu R.,Peking University | Geng X.-N.,Chinese Pharmaceutical Association | Xin X.-X.,Peking University | Chen Z.,Peking University | And 3 more authors.
Chinese Pharmaceutical Journal | Year: 2012

OBJECTIVE: To examine the characteristics of the evidence-based clinical literatures regarding the Chinese patent medicines on the National Essential Medicine List of China (2009 Edition) so as to lay a foundation for the establishment of an evidence-based pharmaceutical review system for the Chinese patent medicines oriented at treating TCM-syndromes. METHODS: The evidence-based literatures on Chinese patent medicines were categorized, and their characteristics were analyzed concerning the distribution of the literatures according to the five levels of evidence, the concentration of the diseases under treatment, and chronological changes; in accordance with the Drug Registration Regulation, the differences among these literatures were explored. RESULTS: With regard to the literatures on some Chinese patent medicines, there were a large proportion of randomized controlled trials (RCTs), with a rapid increase in the number of the literatures in recent years and a clear focus on certain diseases. By contrast, some other Chinese patent medicines had a high proportion of before-after studies and empirical introductions as well as a low concentration of diseases under treatment. CONCLUSION: The Chinese patent medicines can be divided into two categories, namely, the modern branch and the traditional branch. While the disease-oriented evidence-based review system can be applied to the evaluation of the literatures on some patent medicines in the modern branch, it does not fit the traditional branch. Therefore, in order to reflect the characteristics of the Chinese patent medicines, a TCM-syndrome-oriented evidence-based review system has to be established. Copyright 2012 by the Chinese Pharmaceutical Association.


Zhu F.-C.,Chinese Pharmaceutical Association | Wang A.-G.,Chinese Pharmaceutical Association | Han F.,Chinese Pharmaceutical Association | Cao X.-P.,Chinese Pharmaceutical Association | And 2 more authors.
Chinese Pharmaceutical Journal | Year: 2016

OBJECTIVE: To investigate similarities and differences among bioequivalence approaches used by international regulatory authorities when reviewing applications for marketing new generic drug products which are systemically active and intended for oral administration. METHODS: The comparisons of these bioequivalence recommendations were performed and based on bioequivalence study designs, selection of bioequivalence subjects,dosage, selection of reference products, method of pharmacokinetic calculations and bioequivalence acceptance limits, bioequivalence waiver on multiple-strength products and and implementation of the Biopharmaceutics Classification System, which are issued by Australia, the European Medicines Association, Japan,the USA, and the World Health Organization. RESULTS: There were lots of differences were found in bioequivalence approaches among the regulatory authorities surveyed, although there are more similarities. CONCLUSION: Discussion of the similarities and differences among bioequivalence approaches used by international regulatory authorities would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China. Copyright 2016 by the Chinese Pharmaceutical Association.


Xiong J.,National Institutes for Food and Drug Control | Ning B.-M.,National Institutes for Food and Drug Control | Wu J.-M.,National Institutes for Food and Drug Control | He L.,National Institutes for Food and Drug Control | Ding L.-X.,Chinese Pharmaceutical Association
Chinese Pharmaceutical Journal | Year: 2015

OBJECTIVE: To establish the detection technology of riboflavin polymorphism, and investigate the moisture sorption properties of riboflavin. METHODS: The two crystal forms of riboflavin were characterized by different analysis methods, such as powder X-ray diffraction method (p-XRD), differential scanning calorimetry method (DSC) and infrared spectrum method (IR). Dynamic vapor sorption (DVS) analysis was adopted to acquire moisture sorption dynamics of the two crystal forms. The influences of temperature, humidity and light on crystal transformation were explored. RESULTS: The crystal forms of two batches of riboflavin samples were identified as anhydrate I and monohydrate, respectively. The monohydrate could be obtained by recrystallizing in DM-SO. The monohydrate was hygroscopic, the number of crystal water may change at different relative humidities, and the moisture sorption dynamics of the monohydrate was greatly influenced by temperature. The anhydrate I was almost non-hygroscopic, and temperature hardly affected its moisture sorption dynamics. CONCLUSION: Characteristic data for riboflavin polymorphism are obtained, and the results show that anhydrate I is more stable than monohydrate. This study indicates that DVS could be used in studies on drug polymorphism. Copyright 2015 by the Chinese Pharmaceutical Association.


Hao R.-X.,North China Pharmaceutical Co. | Zhu F.-C.,Chinese Pharmaceutical Association | Liu Y.,National Institutes for Food and Drug Control
Chinese Pharmaceutical Journal | Year: 2017

OBJECTIVE: To study and analyze FDA issued guidance on Bioequivalence Recommendations for Specific Products related with long Half-life drugs. METHODS: Bioequivalence Recommendations for Specific Products related with long Half-life drugs was analyzed from multiple aspects, including bioequivalence study designs, selection of bioequivalence subjects, dosage, selection of reference products, analytes to measure, bioequivalence waiver on multiple-strength products and implementation of the Biopharmaceutics Classification System. RESULTS: Bioequivalence Recommendations for Specific Products issued by FDA are to further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval or reassessment, as an extension and implement to the guideline involved in the aspect of bioequivalence. CONCLSUTION: Bioequivalence Recommendations for Specific Products issued by FDA would provide instructive and practical assists to the equivalence assessment of quality and curative effect for generic products in China, since there is not corresponding bioequivalence guidance on specific long Half-life drugs released by CFDA yet. Copyright 2017 by the Chinese Pharmaceutical Association.


PubMed | Northwest University, China, Chinese Pharmaceutical Association and Peking Union Medical College
Type: Journal Article | Journal: Molecules (Basel, Switzerland) | Year: 2015

Using potassium hexacyanoferrate (III)-sodium acetate as oxidant, the oxidative coupling reaction of isorhapontigenin and resveratrol in aqueous acetone resulted in the isolation of three new indane dimers 4, 6, and 7, together with six known stilbene dimers. Indane dimer 5 was obtained for the first time by direct transformation from isorhapontigenin. The structures and relative configurations of the dimers were elucidated using spectral analysis, and their possible formation mechanisms were discussed. The results indicate that this reaction could be used as a convenient method for the semi-synthesis of indane dimers because of the mild conditions and simple reaction products.


Zhang Q.,National Institute of Food and Drug Control | Wang A.,National Institute of Food and Drug Control | Meng Y.,National Institute of Food and Drug Control | Ning T.,National Institute of Food and Drug Control | And 4 more authors.
Analytical Chemistry | Year: 2015

13C NMR spectroscopic integration employing short relaxation delays and a 30° pulse width was evaluated as a quantitative tool for analyzing the components of polysorbate 80. 13C NMR analysis revealed that commercial polysorbate 80 formulations are a complex oligomeric mixture of sorbitan polyethoxylate esters and other intermediates, such as isosorbide polyethoxylate esters and poly(ethylene glycol) (PEG) esters. This novel approach facilitates the quantification of the component ratios. In this study, the ratios of the three major oligomers in polysorbate 80 were measured and the PEG series was found to be the major component of commercial polysorbate 80. The degree of polymerization of -CH2CH2O- groups and the ratio of free to bonded -CH2CH2O- end groups, which correlate with the hydrophilic/hydrophobic nature of the polymer, were analyzed, and were suggested to be key factors for assessing the likelihood of adverse biological reactions to polysorbate 80. The 13C NMR data suggest that the feed ratio of raw materials and reaction conditions in the production of polysorbate 80 are not well controlled. Our results demonstrate that 13C NMR is a universal, powerful tool for polysorbate analysis. Such analysis is crucial for the synthesis of a high-quality product, and is difficult to obtain by other methods. © 2015 American Chemical Society.


Chen B.,Chinese Pharmaceutical Association | Yang Y.-X.,China Pharmaceutical University
Chinese Journal of New Drugs | Year: 2014

The question whether the pioneer drug labeling subject to the Author's Right Law protection in China had been raised again since the ruling of the Changsha People's Court in the case Xiangbei Welman Pharm. Co. vs. Suzhou Erye Pharm. Co. was published. Arguments are mostly focused on whether an Author's Right exists on a pioneer drug product's labeling. To establish the right, the labeling should be approved as original intellectual creations, and the rulings of the US court in Computer Association International, Inc. v. Altai, Inc. could be a good test to the originality. Further questions remain not solved, because the conflicts between the new drug originator's copyright on the labeling and the privilege the competent authority invested to the generic manufacturers. Similar dilemma had also embarrassed the US government and the industry before. The right solution is to give propriety to the generic drug regulations than the copyright of the pioneer drug labeling so that to encourage generic penetration, and in turn to guarantee the public affordability of medicines. Suggestions to the Chinese legislation, regulation and pharmaceutical industry are also proposed.


Wang J.,National Institutes for Food and Drug Control | Huang X.,National Institutes for Food and Drug Control | Cao J.,National Institutes for Food and Drug Control | Wang G.,National Institutes for Food and Drug Control | And 2 more authors.
Chinese Journal of Chromatography (Se Pu) | Year: 2014

An analytical method using ultra-high performance liquid chromatography (UPLC) was developed for qualitative and quantitative analysis of 25 illegally added drugs in diet health foods. The diet food samples were extracted using 40 mL methanol by sonication. After centrifu-gation, the supernatants were separated on a Waters HSS T3 column with gradient elution at a flow rate of 0. 3 mL/min, coupling with diode array detection (DAD) in wavelength range from 200 nm to 400 nm. The binary mobile phase was acetonitrile and 10 mmol/L ammonium acetate solution (containing 0. 1% formic acid). The correlation coefficient of standard curve for each drug in linearity range was not less than 0. 997, as well as the recoveries of all the drugs in diet health foods were 70. 7%-104% with the relative standard deviations (RSDs) of 0. 132%-5. 03% at three spiked levels. Seventeen diet food samples were tested, in which phenolphthalein was found in three samples and emodin was found in one sample. The method is specific, easy, quick, and suitable for confirmation of the 25 illegally added drugs in diet health foods.


PubMed | National Institute of Food and Drug Control and Chinese Pharmaceutical Association
Type: Journal Article | Journal: Analytical chemistry | Year: 2015

(13)C NMR spectroscopic integration employing short relaxation delays and a 30 pulse width was evaluated as a quantitative tool for analyzing the components of polysorbate 80. (13)C NMR analysis revealed that commercial polysorbate 80 formulations are a complex oligomeric mixture of sorbitan polyethoxylate esters and other intermediates, such as isosorbide polyethoxylate esters and poly(ethylene glycol) (PEG) esters. This novel approach facilitates the quantification of the component ratios. In this study, the ratios of the three major oligomers in polysorbate 80 were measured and the PEG series was found to be the major component of commercial polysorbate 80. The degree of polymerization of -CH2CH2O- groups and the ratio of free to bonded -CH2CH2O- end groups, which correlate with the hydrophilic/hydrophobic nature of the polymer, were analyzed, and were suggested to be key factors for assessing the likelihood of adverse biological reactions to polysorbate 80. The (13)C NMR data suggest that the feed ratio of raw materials and reaction conditions in the production of polysorbate 80 are not well controlled. Our results demonstrate that (13)C NMR is a universal, powerful tool for polysorbate analysis. Such analysis is crucial for the synthesis of a high-quality product, and is difficult to obtain by other methods.

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