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Regulation & Policy: market research reports

Reports in this category will address the important role of regulation and policy in the healthcare market. As a highly regulated industry in most countries, healthcare marketers need to be aware of regulations in the countries where they sell products. Regulation will commonly refer to the actions of administrative bodies and existing laws, where as Policy would include potential laws and partial actions of state legislatures or congress.

Given that regulatory activity in the healthcare industry is intense and that policy debates are numerous, pharmaceutical or device markets need an awareness of what laws apply to their products.

In the United States drugs, diagnostics and medical devices are regulated by the Food and Drug Administration (FDA). The FDA is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.

The FDA derives its power from the Food, Drug and Cosmetic Act,[7] (Passed in 1938 and amended since) and are codified in Title 21, Chapter 9 of the United States Code. Some other laws that impact the FDA’s authority is Public Health Service Act, parts of the Controlled Substances Act, the Federal Anti-Tampering Act.

Regulation & Policy market research reports and industry analysis

China Pharmaceutical Guidebook Series (4) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Traditional Chinese Medicines and Natural Medi 5/20/2013 \| published by: Access China Management Consulting Ltd. ... a precise chemical structural formula, but also the indications of the majority of traditional Chinese medicines still can not been clearly described by the modern medical terminologies. How the Chinese drug authorities to administer the ... \| read more...	$750.00
South Korea Pharmaceutical Market Outlook 2013 5/14/2013 \| published by: GBI Research ... also provides competitive benchmarking for the country’s leading pharmaceutical companies and analyzes the M&A (Mergers and Acquisitions) and strategic partnerships that shape its pharmaceutical industry. It is built using data and information sourced from proprietary ... \| read more...	$3,500.00
Conference Documentation: Generics and Patent Strategies 2013 5/13/2013 \| published by: SMI Publishing, Ltd ... key challenges faced within the Generics industry today. Presentations and panel discussions hosted by some of the key opinion leaders within the field of generics will provide delegates with the opportunity to address the challenges ... \| read more...	$788.78
China Pharmaceutical Guidebook Series (3) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Biological Products 5/10/2013 \| published by: Access China Management Consulting Ltd. ... behind the developed countries. The requirements of materials and clinical trials for registration application of biopharmaceuticals stipulated by the Chinese pharmaceutical authority are far from systematic and harmonized. In China, the pharmaceutical regulatory authority ----- ... \| read more...	$750.00
Russian Pharma Industry In Details 5/9/2013 \| published by: Euroresearch & Consulting ... The report is ready to be used for presentations, research reports and strategies. The report could also be used in preparation of marketing materials. The focus of the report – development of pharma market in ... \| read more...	$3,750.00
Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Improve the Competitiveness of Japanese Players 4/29/2013 \| published by: GBI Research ... latest research “Japan Pharmaceutical Market Outlook - Deregulation and More Efficient New Drug Approval Process Attract Foreign Investment and Improve the Competitiveness of Japanese Players”. Japan’s pharmaceutical industry is the second largest in the world, ... \| read more...	$3,500.00
Perspective: StudyOptimizer — Empowering Clinical Trial Enrollment Collaboration at Big Pharma 4/23/2013 \| published by: IDC ... that will be laid out in a much broader foundational discussion of collaboration in the new age of fully integrated pharmaceutical network (FIPNET) that will be published later this year. As leading life science companies ... \| read more...	$1,500.00
Healthcare, Regulatory and Reimbursement Landscape - Belgium 4/22/2013 \| published by: GlobalData ... regulatory and reimbursement landscape, it identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, and reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the ... \| read more...	$1,995.00
Healthcare, Regulatory and Reimbursement Landscape - Argentina 4/22/2013 \| published by: GlobalData ... regulatory and reimbursement landscape, it identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, and reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the ... \| read more...	$1,995.00
China Pharmaceutical Guidebook Series (2) 2013 Edition Material and Clinical Trial Requirements of Application and Approval for Imported Drug Registration: A Guidebook of Registration Application for Imported Chemical Drugs 4/20/2013 \| published by: Access China Management Consulting Ltd. ... to the imported drugs from overseas pharmaceutical manufacturers and producers. By 2012, sales of imported drugs have shared one fourth on the Chinese drug market. As China joins the World Trade Organization (WTO) and integrates ... \| read more...	$750.00
The Worldwide Guide to Pricing & Reimbursement 4/16/2013 \| published by: Espicom Healthcare Intelligence Provides insight into pharmaceutical pricing and reimbursement systems around the world! \| read more...	$995.00
China Pharmaceutical Guidebook Series (1)_2013 Edition Latest Chinese Regulations for Imported Drug Registration: A Comprehensive Guidebook for Foreign Pharmaceutical Companies 4/10/2013 \| published by: Access China Management Consulting Ltd. ... largest drug markets round the world. By 2012, sales on the Chinese drug market have reached RMB 926.1billion (about US$147 billion) reported by the «2012: Report of China Pharmaceutical Market» published by Chinese Academy of ... \| read more...	$750.00
Oncology Therapeutics Market in India to 2018 - Introduction of Market-Based Pricing to Fuel Price Wars and Intense Competition Among Domestic and Multinational Players 4/8/2013 \| published by: GBI Research ... its latest research, Oncology Therapeutics Market in India to 2018 - Introduction of Market-Based Pricing to Fuel Price Wars and Intense Competition Among Domestic and Multinational Players, which provides in-depth analysis of the key therapeutic ... \| read more...	$3,500.00
The Politics of Pharma (CBRSV042) – Washington, States, and the Courts Impact on the Industry 4/1/2013 \| published by: CBR Pharma Insights, LLC ... same, with the re-election of President Obama, Democratic control of the Senate and Republican control of the House. However, the outcome of the elections will still impact the industry in a variety of ways. The ... \| read more...	$3,900.00
Early-Stage Technology Transfer Collaborations - Enabling Platform Technologies & Deal Synergies between Academia and the Pharmaceutical Industry 4/1/2013 \| published by: GlobalData ... the Pharmaceutical Industry report provides a cross-section of major licensing deals between mid to large-sized pharmaceutical companies and academic and nonprofit research institutions. This report examines the terms, platform technologies, and deal rationale of 25 ... \| read more...	$2,995.00
China Regulatory and Market Access Pharmaceutical Report (2013) 4/1/2013 \| published by: Pacific Bridge Medical ... there and optimize market access to increase sales in China. Drug regulations are complicated in China. This report discusses clinical trials, required drug documentation for approval, GCP, GMP, etc. Once your drug is approved, what ... \| read more...	$1,200.00
Healthcare, Regulatory and Reimbursement Landscape - Sweden 3/31/2013 \| published by: GlobalData ... analysis on Sweden’s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it provides valuable ... \| read more...	$1,995.00
Vendor Assessment: 2012 Top 10 Life Science Software Vendors 3/25/2013 \| published by: IDC ... life science software vendors list includes expanded insights into life science vendor rankings within the life science industry subsegments, research, development, manufacturing and supply chain, and sales and marketing. Eric Newmark, program director at IDC ... \| read more...	$4,500.00
Contract Research Organizations in the US - Industry Market Research Report 3/6/2013 \| published by: IBISWorld ... shorten drug or device development cycles. Furthermore, industry services have been particularly attractive to manufacturers because of the cost savings they have provided in the midst of tough economic conditions. During the next five years, ... \| read more...	$910.00
China Pharmaceutical Market Outlook - Government Incentives, Healthcare Reform and a Rapidly Ageing Population Provide Strong Stimulus for Growth 2/28/2013 \| published by: GBI Research ... Rapidly Ageing Population Provide Strong Stimulus for Growth” provides in-depth analysis of the trends, issues and challenges facing the Chinese pharmaceutical market. It details the macroeconomic environment of China, providing a background of the financial ... \| read more...	$3,500.00
Intellinews - Romania Pharmaceutical Report - February 2013 2/28/2013 \| published by: Intellinews ... statistics and comments. This sector report is ideal to keep you abreast on recent company and industry news. Written by local professionals, it is a unique market and business intelligence analysis, tailored to save time ... \| read more...	$210.00
Healthcare, Regulatory and Reimbursement Landscape - New Zealand 2/25/2013 \| published by: GlobalData ... and analysis on New Zealand`s healthcare, regulatory and reimbursement landscape. It identifies the key trends in the healthcare market and provides insights into the demographic, regulatory and reimbursement landscape and healthcare infrastructure. Most importantly, it ... \| read more...	$1,995.00
Healthcare, Regulatory and Reimbursement Landscape - Thailand 2/25/2013 \| published by: GlobalData ... regulatory and reimbursement landscape, it identifies the key trends in the healthcare market and provides insights into the demographic, regulatory, and reimbursement landscape and healthcare infrastructure. Most importantly, the report provides valuable insights into the ... \| read more...	$1,995.00
The Contract Biomanufacturing Market Outlook to 2017 2/19/2013 \| published by: Datamonitor ... grow 9% per year over the same period. Features and benefits Develop a winning expansion and outsourcing strategy to grow your market share with forecasts through to 2017 Assess the areas to target and use ... \| read more...	$3,500.00
Healthcare, Regulatory and Reimbursement Landscape - Colombia 2/15/2013 \| published by: GlobalData ... regulatory, and reimbursement landscape, this report identifies the key trends in the healthcare market, and provides insights on the demographic, regulatory, and reimbursement landscape, and healthcare infrastructure. Most importantly, the report provides valuable insights into ... \| read more...	$1,995.00

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