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Filtering on: "geography asia"

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Asia Regulatory Roundup: TGA Provides Guidance as Black Triangle Scheme Goes Live (16 January 2018) By Nick Paul Taylor - Published 16 January 2018

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, black triangle, device data, recalls

ICMRA Looks to Make Track-and-Trace Systems Globally Interoperable By Zachary Brennan - Published 11 January 2018

The International Coalition of Medicines Regulatory Authorities (ICMRA) is focusing on aligning existing and planned track and trace systems worldwide, with an eye toward interoperability as many of the existing and planned systems were designed with a national or regional focus.

Categories: News, Asia, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Crisis management, Drugs, Government affairs, Quality, Regulatory intelligence

Tags: ICMRA, track and trace, interoperability

Asia Regulatory Roundup: China Posts Guiding Principles on Device Trials (9 January 2018) By Nick Paul Taylor - Published 09 January 2018

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, dengue vaccine, Sanofi, device inspections

Regulatory Recon: Biopharma and Legislative Questions for 2018 (2 January 2018) By Zachary Brennan - Published 02 January 2018

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, FDA, MHRA, TGA, Biologics and biotechnology, Drugs, Medical Devices

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

FDA Warns Fresenius Kabi API Manufacturing Plant By Zachary Brennan - Published 02 January 2018

The US Food and Drug Administration (FDA) last week released a warning letter sent to Fresenius Kabi’s active pharmaceutical ingredient (API) manufacturing plant for liquid pharmaceutical products in Kalyani, India, for deficiencies that the company says will not impact product supplies.

Categories: News, India, US, FDA, Active pharmaceutical ingredients, Government affairs, Manufacturing

Tags: Fresenius, warning letter, API manufacturing

Asia Regulatory Roundup: TGA Adopts Guidance on Device Priority Review Pathway (2 January 2018) By Nick Paul Taylor - Published 02 January 2018

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, device priority reviews, overseas regulators

Regulatory Strategies for OTC Switch Programs, Implementing EU MDR & IVDR and a Preview of January By Gloria Hall - Published 22 December 2017

Feature articles over the past several weeks provided background, approaches, regulatory considerations, and strategies for implementing prescription to Over-the-Counter (Rx-to-OTC) switch programs; CE marking requirements of IVD medical devices under the new EU regulation; explanation of Annex I general requirements and essential requirements; implementation strategies for the new EU medical devices regulations; and medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes in India.

Categories: Features, India, Europe, US, Clinical, Over the counter drugs, Prescription drugs, In vitro diagnostics, Medical Devices

Tags: Feature Editorial

Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017) By Nick Paul Taylor - Published 19 December 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, Clinical, Drugs, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, adverse event, clinical trials China

UK's MHRA: Apotex Site Does Not Comply With GMP Requirements By Zachary Brennan - Published 18 December 2017

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) found Apotex Research Private Limited's Bangalore, India-based manufacturing site to be noncompliant.

Categories: News, Asia, Europe, MHRA, Compliance, Crisis management, Due Diligence, Manufacturing

Tags: GMP requirements, Apotex, statement of noncompliance

A New Regulatory Paradigm for Medical Devices in India By Dushyant Kumar, MPharm, RAC, Vibhu Yadav, MPharm, Nancy Mathewson, Esq - Published 12 December 2017

This article explains medical device classification rules, manufacturer registration procedures, dossier filing procedures, and pre-clinical and marketing application approval processes.

Categories: Features, India, GHTF, IMDRF, ISO, Medical Devices

Tags: Draft Medical Device Rules 2017, GHTF, Bureau of Indian Standards, BIS

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

FDA Warns Korean OTC Drugmaker Using Noncompliant Contract Manufacturer By Zachary Brennan - Published 12 December 2017

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Seoul, South Korea-based over-the-counter (OTC) drug manufacturer Seindni Co. for current good manufacturing practice (CGMP) violations and labeling concerns.

Categories: News, Asia, US, FDA, Over the counter drugs, Quality

Tags: Coko Loko, Legal Lean Syrup, Seindni

IPRF and IGRP Merge to Become the International Pharmaceutical Regulators Programme  By Zachary Brennan - Published 08 December 2017

With an aim toward better exchanging information and avoiding duplication, the International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) initiatives will merge as of the first of next year and be known as the International Pharmaceutical Regulators Programme (IPRP), according to notes from the IPRF's management committee meeting in Geneva on 12-13 November.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs

Tags: IGDRP, IPRF,

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

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

Lupin Warned by FDA for Deficiencies at Two Facilities By Michael Mezher - Published 15 November 2017

The US Food and Drug Administration (FDA) earlier this month warned Indian drugmaker Lupin Limited for good manufacturing practice (GMP) deficiencies at its facilities in Goa and Indore, India.

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

Tags: Warning Letter, GMP, Lupin, Goa, Indore

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

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

FDA Warns Three Device Companies From US, Germany and France, One Indian API Manufacturer By Zachary Brennan - Published 25 October 2017

The US Food and Drug Administration (FDA) this week released three warning letters sent to medical device manufacturers, including Florida-based UVLrx Therapeutics, Inc., Germany-based DRG Instruments GmbH and France-based ELITech Group SAS, as well as one to Vapi, India-based active pharmaceutical ingredient (API) manufacturer Vital Laboratories.

Categories: News, Asia, Europe, US, FDA, Active pharmaceutical ingredients, Compliance, Manufacturing, Medical Devices

Tags: warning letters, ELISA, CAPA

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

Regulatory Recon: FDA Approves New Shingles Vaccine; NICE Oks Gene Therapy for Rare Condition (23 October 2017) By Zachary Brennan - Published 23 October 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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

Regulatory Recon: FDA Approves CAR-T Therapy from Gilead’s Kite (19 October 2017) By Zachary Brennan - Published 19 October 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

Categories: News, Asia, Europe, US, EC, EMA, FDA, Biologics and biotechnology, Drugs, Medical Devices

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

WHO Will Hold Off on Using Biological Qualifiers for Biosimilars By Zachary Brennan - Published 19 October 2017

No consensus has been reached on whether the World Health Organization (WHO) should continue with its biological qualifier proposal in assigning international nonproprietary names for biosimilars, and WHO says it "will not be proceeding with this at present," according to an October report.

Categories: News, Asia, Europe, US, WHO, Biologics and biotechnology, Labeling, Postmarket surveillance

Tags: biological qualifier, biosimilar naming