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Filtering on: "organizations agencies/organizations tga"

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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

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

TGA Weighs Changes to Regulations for Personalized, 3D Printed Devices By Michael Mezher - Published 09 November 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday launched a consultation on proposed changes to the country's medical device regulations for personalized and 3D printed medical devices.

Categories: News, Oceania, TGA, Manufacturing, Medical Devices, Submission and registration

Tags: 3D-Printing, Custom Medical Devices

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

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

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

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

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

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

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

Asia Regulatory Roundup: TGA Takes Tougher Line on Incomplete GMP Clearance Applications (12 September 2017) By Nick Paul Taylor - Published 12 September 2017

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

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

Tags: Asia Regulatory Roundup

MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

Asia Regulatory Roundup: China’s Supreme Court Clarifies Legal Scope to Punish Trial Data Fraudsters (22 August 2017) By Nick Paul Taylor - Published 22 August 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, Drugs, Government affairs, Medical Devices

Tags: NPPA, knee implants, pharmacovigilance

Bioequivalence Studies of Solid Oral Dosage Forms Overview By Sharry Arora - Published 16 August 2017

The article discusses regulations and guidance for conducting bioavailability and bioequivalence studies required to obtain generic product approval across various markets. Included are comparative regulatory approaches for establishing bioequivalence of generic drugs to their corresponding reference drugs across various international jurisdictions, including Australia, Canada, EU, Japan and the US.

Categories: Features, EMA, FDA, Health Canada, MHLW, PMDA, TGA, WHO, Generic drugs

Tags: Bioequivalence, BE Studies, Solid Oral Dosage Forms, Bioavailability

Asia Regulatory Roundup: No Manufacturers Have Complied With India's GMP Request (15 August 2017) By Nick Paul Taylor - Published 15 August 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, DCGI, GMP/GLP

Asia Regulatory Roundup: CFDA Seeks Feedback on Guidance for Medical Device Clinical Trial Sites (8 August 2017) By Nick Paul Taylor - Published 08 August 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, Drugs, Medical Devices, Regulatory strategy, Submission and registration

Tags: Asia Regulatory Roundup, China guidance

Asia Regulatory Roundup: Australia Proposes to Align Device Regulations With EU (1 August 2017) By Nick Paul Taylor - Published 01 August 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, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, medical device regulations, online regulatory filing

TGA Consults on Biological Naming By Michael Mezher - Published 28 July 2017

Australia's Therapeutic Goods Administration (TGA) on Friday launched a public consultation to gather feedback on proposals for potential biological naming systems, including options for EU- or US-aligned systems.

Categories: News, Oceania, TGA, Biologics and biotechnology

Tags: Biological Naming, Biosimilars, INN, Nonproprietary Name, Suffix, Biological Qualifier

Asia Regulatory Roundup: India Seeks Feedback on Medical Device Safety and Performance Principles (25 July 2017) By Nick Paul Taylor - Published 25 July 2017

India has released draft guidance on the safety and performance of medical devices. The text gives companies flexibility in how they meet the design and manufacturing requirements officials see as essential to the safe, effective functioning of medical devices.

Categories: News, India, Oceania, CDSCO, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: Pfizer, Sanofi Raise Concerns on TGA Complementary Medicine Proposal (18 July 2017) By Nick Paul Taylor - Published 18 July 2017

Pfizer and Sanofi have told the Therapeutic Goods Administration (TGA) its planned changes to the rules governing complementary medicines will increase regulatory burdens. The two big pharma companies were among the organizations to raise concerns proposed changes to TGA assessment pathways and other reforms will increase burdens while decreasing flexibility.

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

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: CFDA Expands Trial Data Quality Monitoring Drive to Cover Medical Devices (11 July 2017) By Nick Paul Taylor - Published 11 July 2017

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

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

Tags: Asia Regulatory Roundup, J&J, Boehringer Ingelheim

Australia’s TGA to Take Over Regulation of Therapeutic Goods Advertising By Zachary Brennan - Published 07 July 2017

Beginning 1 July 2018, Australia’s Therapeutic Goods Administration (TGA) will be responsible for receiving and considering all complaints about drug and medical device advertisements directed at the public under what it calls "a simplified complaints system."

Categories: News, Oceania, TGA, Advertising and Promotion, Biologics and biotechnology, Drugs, Medical Devices

Tags: TGA, drug advertising Australia

Asia Regulatory Roundup: India’s DCGI Asks Industry How to Further Cut Regulatory Burdens (5 July 2017) By Nick Paul Taylor - Published 05 July 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, DCGI, state drug regulators India

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017) By Nick Paul Taylor - Published 27 June 2017

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

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

Tags: priority review, China in ICH, CFDA backlog, Indian pharmaceuticals