Search Results for Asia Regulatory Roundup

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Asia Regulatory Roundup: India Offers Fast-Track Approvals to HIV, Hepatitis Combo Products (28 March 2017) By Nick Paul Taylor - Published 28 March 2017

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

Categories: News, Asia, CDSCO, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Asia regulatory roundup, fast-track approvals, combination products, antibiotic resistance

Asia Regulatory Roundup: India Proposes Platform to Monitor Drug Supply Chain (21 March 2017) By Nick Paul Taylor - Published 21 March 2017

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

Categories: News, Asia, CDSCO, TGA, Biologics and biotechnology, Drugs, Government affairs, Postmarket surveillance

Tags: Asia regulatory roundup, India drug supply, TGA pharmacovigilance

Asia Regulatory Roundup: Pfizer Asks TGA to Rethink Timeline for Biologics AE Reporting (14 March 2017) By Nick Paul Taylor - Published 14 March 2017

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

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

Tags: Asia Regulatory Roundup, Pfizer, NPPA, stents

Asia Regulatory Roundup: TGA Increases Inspections Following Adoption of Risk-Based Approach (7 March 2017) By Nick Paul Taylor - Published 07 March 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, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, TGA inspections, NPPA

Asia Regulatory Roundup: J&J, Novartis and Pfizer Comment on Australian Risk Management Proposals (28 February 2017) By Nick Paul Taylor - Published 28 February 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, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, Pfizer, J&J, Novartis, stents

Asia Regulatory Roundup: India Asks China to Expedite GMP Inspection to Resolve a Drug Shortage (14 February 2016) By Nick Paul Taylor - Published 14 February 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, Government affairs, Manufacturing

Tags: Asia Regulatory Roundup, drug shortage, GMP inspection, India online portal

Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) By Nick Paul Taylor - Published 24 January 2017

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, clinical trial guidance, import licenses, advisory committees

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

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: TGA Consults on Accelerated Assessments for Devices (22 November 2016) By Nick Paul Taylor - Published 22 November 2016

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

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

Tags: Asia Regulatory Roundup, accelerate assessments medical devices

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

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

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

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: 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: CFDA Revises Preclinical Guidance (23 August 2016) By Nick Paul Taylor - Published 23 August 2016

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

Categories: News, Asia, CDSCO, CFDA, TGA, Drugs, Due Diligence, Preclinical

Tags: Asia Regulatory Roundup, preclinical guidance, CFDA reforms

Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016) By Nick Paul Taylor - Published 16 August 2016

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

Categories: News, Asia, Oceania, CFDA, TGA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, clinical trial fraud, metformin, drug manufacturing

Asia Regulatory Roundup: India Allows Parallel Submission of Trial Filings for Insulins, mAbs (9 August 2016) By Nick Paul Taylor - Published 09 August 2016

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, Business Skills, Drugs, Quality, Regulatory intelligence, Regulatory strategy

Tags: DCGI, insulin, RCGM, mAb, Asia Regulatory Roundup

Asia Regulatory Roundup: Indonesia to Overhaul Drug Regulator (20 July 2016) By Nick Paul Taylor - Published 20 July 2016

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

Categories: News, Asia, CDSCO, CFDA, Drugs

Tags: Asia Regulatory Roundup

Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (5 July 2016) By Nick Paul Taylor - Published 05 July 2016

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Due Diligence

Tags: Asia Regulatory Roundup, biosimilar guidance