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Asia Regulatory Roundup: CFDA Offers Guidance on Device Quality Control (10 January 2017) By Nick Paul Taylor - Published 10 January 2017

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

Categories: News, Asia, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: AstraZeneca, Bristol-Myers Squibb, Merck, CDSCO, codeine

International Generic Drug Regulators Outline Plans for Collaboration Through 2020 By Zachary Brennan - Published 09 January 2017

As further cross-border harmonization among pharmaceutical regulators takes shape, the International Generic Drug Regulators Programme (IGDRP) has laid out its priorities that will take the group through the next four years.

Categories: News, Africa, Asia, Canada, Europe, US, Anvisa, CFDA, EC, EMA, FDA, Health Canada, ICH, Medsafe, MHLW, PMDA, TGA, WHO, Generic drugs, Due Diligence, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: generic drug regulation, COFEPRIS, DMFs, ASMFs

Asia Regulatory Roundup: CFDA Offers Draft Guidance on Generic Drug Manufacturing Inspections (3 January 2017) By Nick Paul Taylor - Published 03 January 2017

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, CFDA guidance, generic drug inspections, codeine

Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016) By Nick Paul Taylor - Published 20 December 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, India biologic licenses, cashless economy

Asia Regulatory Roundup: CFDA Shifts to Random Inspections (6 December 2016) By Nick Paul Taylor - Published 06 December 2016

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

Categories: News, Asia, ANZTPA, CDSCO, CFDA, Medsafe, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: GMP pharmaceutical manufacturing, Chinese drug inspections, DTAB, Sugam, Asia Regulatory Roundup

Asia Regulatory Roundup: India Begins Reviewing Drug Recall Guidelines (29 November 2016) By Nick Paul Taylor - Published 29 November 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug recalls, medicinal cannabis, antidiabetic

Asia Regulatory Roundup: Vietnam Drug Agency Adds Aurobindo, Other Indian Drugmakers to Blacklist (15 November 2016) By Nick Paul Taylor - Published 15 November 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, TGA, Biologics and biotechnology, Drugs, Labeling, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: drug advertising, social media and pharmaceuticals, Aurobindo Pharma

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

Regulatory Recon: Astellas to Buy Ganymed for up to $1.4B; Sanofi, Novo Nordisk Fortunes Diverge (28 October 2016) By Zachary Brennan - Published 28 October 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, Oceania, US, CFDA, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

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

Asia Regulatory Roundup: CFDA Investigates Trial Sites Over Data Integrity (25 October 2016) By Nick Paul Taylor - Published 25 October 2016

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

Categories: News, Asia, CDSCO, CFDA, Clinical, Crisis management, Drugs, Due Diligence, Medical Devices

Tags: Asia Regulatory Roundup, data falsification, Indian medical device rules

Asia Regulatory Roundup: CFDA Releases Draft Guidance on Data Management (18 October 2016) By Nick Paul Taylor - Published 18 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Labeling, Quality

Tags: Asia Regulatory Roundup, GSK, Abbott, data management

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,

Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016) By Nick Paul Taylor - Published 11 October 2016

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

Categories: News, Asia, CDSCO, CFDA, WHO, Active pharmaceutical ingredients, Clinical, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, DCGI, India, GMPs, clinical trial applications in India

Asia Regulatory Roundup: Australia to Adopt 10 EMA Guidelines (4 October 2016) By Nick Paul Taylor - Published 04 October 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Australia drug manufacturing inspections, China medical devices

Regulatory Recon: Cures Bill a Top Priority for Lame-Duck Period; Two Died in Boehringer Trial (30 September 2016) By Zachary Brennan - Published 30 September 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, US, CFDA, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: Regulatory Reconnaissance, Regulatory, Links, News, Regulatory News, Regulatory Intelligence, FDA News, EMA News

Asia Regulatory Roundup: CFDA Continues Crackdown on Dishonest Drug Manufacturers (27 September 2016) By Nick Paul Taylor - Published 27 September 2016

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

Categories: News, Asia, CDSCO, CFDA, MHLW, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, DCGI, China medical devices, CFDA enforcement

Asia Regulatory Roundup: Australia Looks to Establish Expedited Approval Pathway (20 September 2016) By Zachary Brennan - Published 20 September 2016

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

Categories: News, Asia, CFDA, PMDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing

Tags: Thai FDA, Skynet, Australia expedited pathways, CFDA on generics

Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016) By Nick Paul Taylor - Published 13 September 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Crisis management, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

Tags: Pakistan controlled substances, CFDA on devices, TGA committees

ICH and Pharmaceutical Inspection Co-operation Scheme: No Expectations for China or India to Join By Zachary Brennan - Published 12 September 2016

While China and India continue to supply most of the world with pharmaceuticals (and continue to be plagued by quality and data integrity concerns), the Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council on Harmonisation (ICH) – two of the largest international pharmaceutical regulatory schemes – say neither China nor India has any plans to join either group in the near future.

Categories: News, Asia, Europe, US, CDSCO, CFDA, FDA, ICH, Compliance, Crisis management, Drugs, Manufacturing

Tags: ICH, PIC/S, data integrity, pharmaceutical guidance, international pharmaceutical harmonization

Asia Regulatory Roundup: India Continues Clinical Trial Reform Agenda (6 September 2016) By Nick Paul Taylor - Published 06 September 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Quality

Tags: Asia Regulatory Roundup, DCGI, CFDA guidance, metformin

Asia Regulatory Roundup: India’s DCGI Orders Manufacturers to Assess GMP, GLP Compliance (30 August 2016) By Nick Paul Taylor - Published 30 August 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Crisis management, Drugs, Government affairs, Human cell and tissue

Tags: TGA, DCGI, GLP, GMP, stem cells

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