Search Results for Nick Paul Taylor

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Asia Regulatory Roundup: Australia, Singapore Expand Generic Drug Work-Sharing Trial (12 December 2017) By Nick Paul Taylor - Published 12 December 2017

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

Categories: News, Asia, Oceania, TGA, Compliance, Drugs, Government affairs

Tags: Asia Regulatory Roundup, ACSS, GSK, Novartis

European Regulatory Roundup: EU Stands Firm on Demand for UK to Pay for EMA’s Exit (7 December 2017) By Nick Paul Taylor - Published 07 December 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs

Tags: Brexit, PRAC, orphan drugs

Asia Regulatory Roundup: Australia Bans Transvaginal Mesh Products (5 December 2017) By Nick Paul Taylor - Published 05 December 2017

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

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: transvaginal mesh, confidential information, medicine naming

European Regulatory Roundup: EMA’s Rent Bill at €448M (30 November 2017) By Nick Paul Taylor - Published 30 November 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, Amsterdam EMA, Brexit

Asia Regulatory Roundup: CFDA Maps Out Regulatory Transparency (28 November 2017) By Nick Paul Taylor - Published 28 November 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, Medical Devices

Tags: Asia Regulatory Roundup, transparency, inspections

Asia Regulatory Roundup: India Introduces Tougher Regulations on Homeopathic Medicines (20 November 2017) By Nick Paul Taylor - Published 20 November 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

Tags: Asia Regulatory Roundup, online medicines in China, homeopathic

European Regulatory Roundup: EFPIA Warns of Insufficient Time to Move Marketing Authorizations Before Brexit (17 November 2017) By Nick Paul Taylor - Published 17 November 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: European Regulatory Roundup, EU Regulatory Roundup

Asia Regulatory Roundup: Pakistan Proposes Strengthening Quality Control Unit Requirements (14 November 2017) By Nick Paul Taylor - Published 14 November 2017

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

Categories: News, Asia, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Medical Devices, Quality, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

European Regulatory Roundup: ex-GSK CEO to Chair UK Accelerated Access Collaborative (9 November 2017) By Nick Paul Taylor - Published 09 November 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Drugs, Government affairs, Regulatory intelligence

Tags: GSK, accelerated access, DKMA, Celgene

Asia Regulatory Roundup: China Strengthens Supervision of Online Drug, Device Sales (7 November 2017) By Nick Paul Taylor - Published 07 November 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, Medical Devices

Tags: CDSCO, device imports, online drug sales, Pakistan

European Regulatory Roundup: Rise of Cell Therapies Prompts EC to Float Orphan Drug Changes (2 November 2017) By Nick Paul Taylor - Published 02 November 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: cell therapies, Brexit, antimicrobial resistance

Asia Regulatory Roundup: Australia’s TGA to Tighten Regulation of Autologous Cell Products, Ban Ads (31 October 2017) By Nick Paul Taylor - Published 31 October 2017

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

Categories: News, Asia, CFDA, TGA, Biologics and biotechnology, Human cell and tissue, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, autologous cell products, surgical mesh

European Regulatory Roundup: UK Prime Minister Hints at Desire to Remain Part of EMA During Brexit Transition (26 October 2017) By Nick Paul Taylor - Published 26 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: Theresa May, Brexit, antibiotics

Asia Regulatory Roundup: CFDA Posts Draft Guidance on Postapproval Manufacturing Changes (24 October 2017) By Nick Paul Taylor - Published 24 October 2017

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

Categories: News, Asia, CDSCO, CFDA, Drugs, Government affairs

Tags: postapproval manufacturing changes, Sun Pharma

European Regulatory Roundup: MHRA Chief Floats Faster Reviews, Closer Ties to NICE (19 October 2017) By Nick Paul Taylor - Published 19 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Brexit, HPV vaccine, CHMP

Asia Regulatory Roundup: India Tightens Stem Cell Guidelines (17 September 2017) By Nick Paul Taylor - Published 17 October 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, stem cells, black triangle

European Regulatory Roundup: Brexit Sparks Hiring Drive at Danish Medicines Agency (12 October 2017) By Nick Paul Taylor - Published 12 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

Tags: European Regulatory Roundup, Brexit

Asia Regulatory Roundup: China Opens Door to Foreign Trial Data for Accelerated Approvals (10 October 2017) By Nick Paul Taylor - Published 10 October 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

Tags: Asia Regulatory Roundup, China accelerated approval, Pfizer, FDC manufacturers

European Regulatory Roundup: Swissmedic Pilots Changes to Accelerate Drug Authorizations (5 October 2017) By Nick Paul Taylor - Published 05 October 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, Biologics and biotechnology, Drugs

Tags: accelerated approval, Swissmedic, CQC, Guido Rasi

Asia Regulatory Roundup: India Orders J&J and Others to Maintain Output of Knee Implants (3 October 2017) By Nick Paul Taylor - Published 03 October 2017

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

Categories: News, Asia, CDSCO, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, J&J, knee implants

European Regulatory Roundup: EMA Overrode Pharma Concerns in Adopting First-in-Human Guideline (28 September 2017) By Nick Paul Taylor - Published 28 September 2017

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

Categories: News, Europe, EMA, NICE, Biologics and biotechnology, Clinical, Drugs

Tags: European Regulatory Roundup, EU Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: TGA Shares Guidance, Tool to Help Companies Navigate GMP Clearance Process (26 September 2017) By Nick Paul Taylor - Published 26 September 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, Compliance, Drugs, Manufacturing, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup, Pakistan

European Regulatory Roundup: Medtech Industry Pressures Brexit Negotiators to Maintain UK-EU Relationship (21 September 2017) By Nick Paul Taylor - Published 21 September 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EMA, MHRA, Biologics and biotechnology, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: European Regulatory Roundup, Brexit, biosimilar switching, vaccines

Asia Regulatory Roundup: India to Reassess Cardiac Stent Price Ceiling (19 September 2017) By Nick Paul Taylor - Published 19 September 2017

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

Categories: News, Asia, CFDA, TGA, Drugs, Medical Devices

Tags: Asia Regulatory Roundup

European Regulatory Roundup: EMA Explains its Regulatory System (14 September 2017) By Nick Paul Taylor - Published 14 September 2017

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

Categories: News, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

Tags: HPRA, ENVI, CVMP, DKMA