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Filtering on: "geography asia korea"

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FDA Warns Korean Drugmaker Over Testing, GMP Issues By Michael Mezher - Published 03 October 2017

The US Food and Drug Administration (FDA) has warned South Korean drugmaker Dasan E&T Co. Ltd. over product testing issues following an inspection of its Gimpo, Kyonggi-do facility in January.

Categories: News, Korea, US, FDA, Drugs, Manufacturing

Tags: Warning Letter, GMP

Doctors Without Borders: Asian Trade Deal Could Restrict Access to Affordable Generics By Zachary Brennan - Published 21 April 2016

The Regional Comprehensive Economic Partnership (RCEP) trade agreement is kicking off another round of negotiations on Sunday in Australia and Doctors Without Borders (MSF) is raising concerns about the tougher intellectual property rights that could restrict access to affordable generic drugs for many in Indonesia, Thailand, Myanmar, Cambodia and Laos.

Categories: News, Asean, China, India, Japan, Korea, Generic drugs, Government affairs

Tags: MSF, Doctors Without Borders, KEI, HIV, TB, Indian generic drugs

India Releases New Biosimilars Guidance By Zachary Brennan - Published 28 March 2016

India’s Central Drugs Standard Control Organization (CDSCO) on Saturday released new guidance for biosimilar developers as new biosimilars come to market there before other regions, and as India's regulators look to develop more specific guidance on postmarketing studies.

Categories: News, India, Korea, CDSCO, Biologics and biotechnology, Clinical, Government affairs, Manufacturing, Postmarket surveillance

Tags: biosimilars, biosimilar guidance, CDSCO guidance, India biosimilars, Herceptin

World Drug Firsts from Asia (Outside Japan) By Kwee-Tat Chew, MBA, BPharm, Rao Meenakshi, PhD, RAC - Published 09 March 2016

This article discusses some notable drug firsts from Asia (outside Japan) and reaffirms the innovation potential in this region, beginning with a reference to the discovery of artemisinin, a valuable drug and key ingredient in the fight against malaria, and concluding with a reference to a new paradigm: a shift of the "center of gravity" of innovation from the West toward the East.

Categories: Features, Asean, China, India, Korea, Taiwan, CDSCO, CFDA, MFDS, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Korean Device Firm Denies FDA Inspection By Zachary Brennan - Published 02 March 2016

A South Korean insulin syringe and pen needle manufacturer on Wednesday became the fifth foreign company to currently have its products banned from entry into the US after denying an inspection by the US Food and Drug Administration (FDA).

Categories: News, Korea, FDA, Compliance, Crisis management, Manufacturing, Medical Devices, Quality

Tags: insulin manufacturing, foreign device inspection, FDA inspection

Drug Development in Asia: Scattering the Mist By Kwee-Tat Chew, MBA, BPharm, Rao Meenakshi, PhD, RAC - Published 23 February 2016

This article discusses misconceptions and their causes, surrounding drug development in Asia, and explains the regions current drug development landscape.

Categories: Features, Asean, China, Japan, Korea, APEC, CFDA, ICH, MFDS, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Submission and registration

Tags: Data exclusivity, tripartite cooperation on clinical research, Tripartite Working Group, TRIPS, ICH-E5, APEC, ASEAN, Biosimilars

Asia Regulatory Roundup: CFDA Chips Away at Backlog of Applications (15 December 2015) By Nick Paul Taylor - Published 15 December 2015

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

Categories: News, China, India, Japan, Korea, Taiwan, CDSCO, CFDA, MHLW, Biologics and biotechnology, Clinical, Distribution, Drugs, Ethics, Government affairs, Manufacturing, Medical Devices, Quality

Tags: CFDA, CDSCO, Korean biosimilars, drug applications

Asia Regulatory Roundup: CFDA Continues Medical Device Quality Drive (27 October 2015) By Nick Paul Taylor - Published 27 October 2015

China Food and Drug Administration (CFDA) has released another document about the quality of medical devices. The regulator’s latest missive moves its focus further down the supply chain to address quality aspects of the procurement, storage, use and maintenance of medical devices.

Categories: News, Asean, China, India, Japan, Korea, Taiwan, Oceania, CDSCO, CFDA, MFDS, MHLW, TGA, Biologics and biotechnology, Distribution, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: Regulatory Roundup, Asia Regulatory Roundup

Asia Regulatory Roundup: China to Strengthen Oversight of Medical Device Manufacturing (13 October 2015) By Nick Paul Taylor - Published 13 October 2015

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

Categories: News, China, Japan, Korea, Oceania, CFDA, Medsafe, PMDA, TGA, Crisis management, Drugs, Government affairs, Manufacturing, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: CFDA, medical device manufacturing, PMDA, TGA, Myriad Genetics

Asia Regulatory Roundup: Medsafe Updates Recall Process Following Public Consultation (8 September 2015) By Nick Paul Taylor - Published 08 September 2015

New Zealand Medicines and Medical Devices Safety Authority (Medsafe) has revised its drug and medical device recall process. The document is far more comprehensive than the one it replaces, notably because it includes additional information about how to decide on and execute recalls.

Categories: News, Asean, China, India, Japan, Korea, Oceania, CFDA, Medsafe, MHLW, PMDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: Pakistani Manufacturers Shut Down in Protest Against Regulatory Amendment (18 August 2015) By Nick Paul Taylor - Published 18 August 2015

Members of the Pakistan Pharmaceutical Manufacturers Association (PPMA) have shut down their units in protest against regulatory changes. The actions were later postponed following the death of a politician, but PPMA still has grievances with government plans to hand out 10-year prison terms for manufacturers of substandard medicines.

Categories: News, Asean, China, India, Japan, Korea, Taiwan, Oceania, CDSCO, CFDA, PMDA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Asia Regulatory Roundup: Malaysia Posts Draft Medical Device Guidelines (7 July 2015) By Nick Paul Taylor - Published 07 July 2015

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

Categories: News, China, India, Korea, Oceania

Tags: Asia Regulatory Roundup, Regulatory Roundup

The Biggest Challenge for Regulators That No One's Talking About: Translation By Michael Mezher - Published 04 May 2015

Regulators have long been concerned with the safety, efficacy and quality of the products they regulate. Now they have a new concern to think about: language.

Categories: News, Korea, MFDS, Communication, Government affairs

Tags: Language barriers, communication

The Essential List of Regulatory Authorities in Asia By Michael Mezher - Published 06 April 2015

It can be difficult to keep track of regulators on a global scale. To make finding the relevant websites for the various regulatory authorities and ministries of health around the world a little easier, Focus will be building resources for major regions.

Categories: News, Asean, China, India, Japan, Korea, Taiwan, Middle East, Oceania, APEC, CDSCO, Medsafe, PMDA, TGA, Drugs, Government affairs, Medical Devices, Regulatory strategy

Tags: East Asian Regulators, Southeast Asian Regulators, Central Asian Regulators, Middle Eastern Regulators, Regulatory Tracker, APEC, ASEAN, AHWP

South Korean Regulators to Require Clinical Data for Many Class IV Medical Devices By Stewart Eisenhart, Emergo - Published 17 March 2015

South Korea’s medical device market regulator, the Ministry of Food and Drug Safety (MFDS), will begin requiring clinical data for dozens of medical devices in January 2016 that currently can avoid such requirements if their equivalence to predicate devices already on the South Korean market can be shown.

Categories: News, Korea, Clinical, Medical Devices

Tags: Emergo, Emergo Group, MFDSm South Korea, Ministry of Food and Drug Safety

Regulatory Focus Recap: February 2015 By Janet Aker - Published 03 March 2015

A recap of Regulatory Focus feature articles published in February 2015 for your reading convenience.

Categories: Features, Africa, Korea, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: outsourcing

Pharmaceutical Outsourcing: A Korean Perspective By Dong-Hyuk Jeon and Siegfried Schmitt, PhD - Published 04 February 2015

Background on the South Korean pharmaceutical industry and how companies select and choose suppliers and contractors, including regulatory affairs or regulatory compliance consultants or providers.

Categories: Features, Korea, Drugs, Regulatory strategy

Key Changes to South Korean KGMP, IVD Regulations Set for 2015 By Stewart Eisenhart, Emergo - Published 30 January 2015

South Korean medical device regulators will implement significant changes affecting compliance requirements for in vitro diagnostic (IVD) registration as well as for Korean Good Manufacturing Practice (KGMP) audits over the course of 2015.

Categories: News, Korea, In vitro diagnostics, Medical Devices, Submission and registration

Tags: Emergo Group, Emergo, South Korea, MFDS

Asia Regulatory Roundup: China's New Device Regulations (19 January 2014) By Nick Paul Taylor - Published 20 January 2015

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

Categories: News, China, India, Korea, CDSCO, CFDA, Drugs, Medical Devices, Regulatory intelligence

Tags: Regulatory Roundup, Asia Regulatory Roundup

South Korean Medical Device Regulators Ban Some Raw Materials By Stewart Eisenhart, Emergo Group - Published 02 December 2014

South Korea’s Ministry of Food and Drug Safety (MFDS) has identified certain raw materials that will now be prohibited from use in medical device production.

Categories: News, Korea, Manufacturing, Medical Devices

Tags: Emergo Group, Asbestos, Phthalates, Mercury

Goodbye, KFDA: Korean Regulator Gets New Name, Decentralized Authority After Reorganization By Alexander Gaffney, RF News Editor - Published 28 March 2013

Categories: Asia, Korea, MFDS

Tags: KFDA, Reorganization, Latest News, pharmaceutical, drug

South Korea Scrambles to Strengthen Import Controls as Capsules Seized Containing Human Flesh By Alexander Gaffney - Published 08 May 2012

Categories: Korea

Tags: Disturbing, Baby, Fetus, Flesh, Capsules, South Korea, Import, Latest News

Korea, Japan Apply for PIC/S Membership By Alexander Gaffney - Published 23 April 2012

Categories: Japan, Korea, PMDA, Quality

Tags: Scheme, PIC/S, PIC, KFDA, Latest News, pharmaceutical, Inspection, drug

Device Safety Reassessed Published 09 April 2012

Categories: Regulatory Update, Korea, FDA

Tags: Consumer Reports, safety, device

Korea to Bring Certification for Clinical Trial Experts Published 21 December 2011

Categories: Korea, Clinical, Regulatory intelligence

Tags: KoNECT, trial, clinical trial