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Filtering on: "geography asia china"

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FDA Warns Two Drugmakers in China and India for Data Integrity Violations By Michael Mezher - Published 21 March 2017

The US Food and Drug Administration (FDA) has warned two drugmakers, USV Private Limited in Daman, India and Jinan Jinda Pharmaceutical Chemistry Co., Ltd. in Zhangqiu City, China, over data integrity and manufacturing issues uncovered during inspections last year.

Categories: News, China, India, US, FDA, APIs, Compliance, Drugs, Manufacturing

Tags: Data Integrity

House Committee Asks FDA for More Info on Contaminated Heparin Investigations By Zachary Brennan - Published 15 March 2017

Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed.

Categories: News, China, US, FDA, Crisis management, Drugs, Government affairs, Manufacturing

Tags: heparin, China heparin, House E&C, FDA investigations

FDA Warns China API Manufacturer for Data Integrity Violations By Michael Mezher - Published 01 March 2017

The US Food and Drug Administration (FDA) in late February warned Fosun Pharmaceutical subsidiary, the formerly Chinese state-owned Chongqing Pharmaceutical Research Institute (CPRI), over data integrity issues.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs

Tags: Data Integrity

CFDI's Global Drug Inspection Trend Study Offers Regulatory Updates and Opinions By Yingying Liu, Siegfried Schmitt - Published 15 February 2017

To help keep regulatory professionals up-to-date on current thinking by global regulatory agencies, the Chinese Center of Food and Drug Inspection (CFDI) released a new electronic journal covering hot topics and developments in international drug manufacturing inspections. This article summarizes the key points including regulatory thinking and opinions from global regulatory authorities and organizations; timely updates on regulations, guidance, regulatory measures and changes; and inspection case analysis through observations by various international regulatory authorities.

Categories: Features, China, CFDA, FDA, WHO, Government affairs, Regulatory intelligence

Tags: Chinese Center of Food and Drug Inspection, CFDI

China Works to Reduce Massive Backlog of Clinical Trial and Marketing Applications By Zachary Brennan - Published 15 February 2017

China Food and Drug Administration (CFDA) is facing increasing pressure as a backlog of pharmaceutical marketing and clinical trial applications grow, though trial standards there are approaching those of international standards, according to a perspective published in Nature Reviews Clinical Oncology on Tuesday.

Categories: News, China, CFDA, Biologics and biotechnology, Clinical, Compliance, Drugs, Government affairs

Tags: CFDA, clinical trials in China, drug approvals in China

CFDA Publishes Four Draft Guidances on Inspections of Generic Drug Development By Yingying Liu, Siegfried Schmitt - Published 06 February 2017

This article provides the details of four draft guidances published on 21 December 2016 by the China Food and Drug Administration (CFDA) regarding on-site inspection of generic drugs, including how CFDA will be evaluating their quality and efficacy and possible inspection outcomes and the responsibilities of 31 local province level FDA inspection teams in China.

Categories: Features, China, CFDA, Clinical, Compliance, Generic drugs, Prescription drugs

Tags: Draft Guidance

Regulatory Intelligence, Leading Edge Technology, Compliance Strategy, Scientific Research and a Preview of February By Gloria Hall - Published 06 February 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in February.

Categories: Features, China, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, Biologics and biotechnology, Compliance, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles, Feature Summary

Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017) By Nick Paul Taylor - Published 18 January 2017

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016) By Nick Paul Taylor - Published 08 November 2016

China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Generic drugs, Medical Devices, Nutritional and dietary supplements, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: CFDA Offers Device Monitoring Guidance (1 November 2016) By Nick Paul Taylor - Published 01 November 2016

Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia.

Categories: News, China, India, CDSCO, CFDA, MHLW, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, adverse event monitoring, device standards, radioactive drugs

Draft CFDA Guidance on Drug Data Management Practices By Yingying Liu, Siegfried Schmitt - Published 31 October 2016

The China Food and Drug Administration (CFDA) has recently issued a new draft guidance document on data integrity, covering the entire data lifecycle from R&D to commercial production and distribution. This article is a translation of the summary of the draft guidance.

Categories: News, China, CFDA, Clinical, Manufacturing, Preclinical, Research and development

Tags: Data Management

China to Begin Priority Reviews of Medical Devices in January 2017 By Zachary Brennan - Published 27 October 2016

China Food and Drug Administration (CFDA) announced Thursday that its priority review and approval procedure for medical devices will come into force as of 1 January 2017. 

Categories: News, China, CFDA, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: China priority reviews for devices, accelerated approval for medical devices

China Food and Drug Administration Issues New Requirements for Clinical Trial Applications and New Drug Applications By Gretchen Dean, MA, Joel Hardink, MBA, MS - Published 17 October 2016

This article discusses the growth of China's pharmaceutical market, background of the global use and acceptance of the Common Technical Document (CTD), outlines the China Food and Drug Administration (CDFA) requirements for Clinical Trial Application (CTA) approval and New Drug Application (NDA) registration as critical steps in addressing drug quality, patient safety and shortening the time for access to new drugs.

Categories: News, China, CFDA, ICH, Clinical, Drugs, Submission and registration

Tags: Electronic common technical document, eCTD, Clinical trial application, CTA,

'The Rooms Had Never Been Cleaned': Two New FDA Warning Letters for Chinese Manufacturers By Michael Mezher - Published 27 September 2016

The US Food and Drug Administration (FDA) has sent warning letters to two Chinese active pharmaceutical ingredient (API) makers over data integrity and good manufacturing practice (GMP) violations.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing

Tags: Data integrity, warning letter

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

Flying Insects and Chipping Paint: FDA Warns Chinese API Manufacturer By Zachary Brennan - Published 30 August 2016

Two of Xinxiang Pharmaceutical’s China-based manufacturing facilities received a US Food and Drug Administration (FDA) warning letter on 19 August after FDA inspectors found drug manufacturing equipment and facilities in such a state of disrepair as to be unsalvageable.

Categories: News, China, FDA, Active pharmaceutical ingredients, Crisis management, Drugs, Government affairs, Manufacturing, Product withdrawl and retirement, Quality

Tags: Chinese API manufacturing, FDA warning letters

China Food Safety Regulatory Framework By Dr. Junshi Chen - Published 25 August 2016

This article discusses changes in the regulatory control aspects of food safety in China over the past three decades, including the Ministry of Agriculture's continuing responsibility for primary agricultural food products control, the 2009 Food Safety Law1 and the newly established China Food and Drug Administration (CFDA). Health food and vitamin supplements also are discussed.

Categories: Features, China, CFDA, Nutritional and dietary supplements

Tags: Food Safety

Entering the China Market: Go-to-Market Strategies - Part 2 By Landon G. Lack - Published 23 August 2016

This is the second of a two-part series looking at best practices for medical device companies planning to enter the China market.

Categories: Features, China, Business Skills, Medical Devices

FDA Warns 14 International Medical Device Companies By Michael Mezher - Published 16 August 2016

The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines.

Categories: News, China, Europe, Latin America and Caribbean, US, CDRH, Medical Devices

Tags: Quality System Regulation, Medical Device Reporting, Corrective and Preventative Action, CAPA, Warning Letter

August Feature Articles Highlight Food Regulatory Paradigms: the Right Paths for Nutrition, Health and Disease Management By Gloria Hall - Published 04 August 2016

Over time, the regulatory framework has evolved and continues to protect consumers and patients. However, with the unprecedented changes in demographics and advances in healthcare, it is even more important for regulatory professionals to continue to deliver timely, appropriate and affordable healthcare solutions to patients and society. And this changing healthcare paradigm with food (health) and drug (disease) systems moving closer together has created possible new opportunities and questions regarding historic pharmaceutical and nutrition "models."

Categories: Features, News, China, US, CFDA, FDA, Compliance, Manufacturing

Tags: Food, Nutrition

FDA Continues Crackdown on Chinese Drug Manufacturers With new Warning for Xiamen By Michael Mezher - Published 02 August 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Chinese drug manufacturer Xiamen Origin Biotech over "significant deviations" in the company's manufacturing practices for active pharmaceutical ingredients (APIs).

Categories: News, China, US, FDA, Active pharmaceutical ingredients, Drugs, Manufacturing

Tags: Xiamen Origin Biotech, Warning Letter, GMP, Import Alert

FDA Warns Two Chinese Drugmakers for Data Integrity Violations By Michael Mezher - Published 30 June 2016

The US Food and Drug Administration (FDA) has issued warning letters to two Chinese drugmakers over manufacturing and data integrity issues, including backdated tests and falsified records.

Categories: News, China, US, FDA, Active pharmaceutical ingredients, APIs, Compliance, Drugs, Manufacturing, Quality

Tags: Data integrity, Warning letter

Asia Regulatory Roundup: India Releases Lengthy Draft Legislation on Medical Devices (28 June 2016) By Nick Paul Taylor - Published 28 June 2016

India has released draft legislation about medical devices. The text defines different types of medical devices, categorizes them by risk and establishes a registration process for all except the products that pose the least threat to users.

Categories: News, China, India, CDSCO, CFDA, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Roundup, Asia Regulatory Roundup

Entering the China Market: Best Practices - Part 1 By Landon G. Lack - Published 09 June 2016

This article explores some of the considerations and best practices for foreign firms prior to entering the Chinese medical device market, specifically prior to and during the registration process.

Categories: Features, China, CFDA, Clinical, Medical Devices, Postmarket surveillance, Submission and registration