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Filtering on: "organizations agencies/organizations apec"

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Regulatory Harmonization Initiatives By Mukesh Kumar, RAC, Eliane Barras, MSc, Lewis Lau, RAC - Published 09 May 2017

This article provides an overview of global regulatory harmonization initiatives and addresses how various regulatory and other organizations are working toward improving access to medicinal products, such as pharmaceuticals and medical devices, and increasing quality through internationally harmonized inspection standards.

Categories: Features, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, APEC, GHTF, ICH, IMDRF, ISO, OECD, WHO, Biologics and biotechnology, Compliance, Drugs, Medical Devices

Tags: Harmonization

Drug Supply Chain Security: New APEC Toolkit to Aid Collaboration By Zachary Brennan - Published 28 March 2017

With the pharmaceutical supply chain becoming more global and complex, regulators, industry groups and academics from around the world have developed a new toolkit of resources to increase harmonization across borders to ensure the quality of drugs from manufacture through ingestion.

Categories: News, Asia, Canada, Europe, US, APEC, FDA, Biologics and biotechnology, Compliance, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: pharmaceutical supply chain, good manufacturing practices, good distribution practices, fake drugs

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: Chinese Distillers Suspected of Lacing Alcohol with Viagra (4 August 2015) By Nick Paul Taylor - Published 04 August 2015

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

Categories: News, China, India, Japan, Oceania, APEC, CDSCO, CFDA, MFDS, MHLW, PMDA, TGA, Biologics and biotechnology, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

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

APEC Moving Toward 'Regulatory Convergence' in Effort to Safeguard Drugs, Improve Manufacturing By Alexander Gaffney, RAC - Published 13 May 2014

Categories: Asia, APEC, Manufacturing

Tags: Adulterated, Counterfeit, Misbranded, Latest News, regulatory convergence

Harmonizing Drug Regulations in the Gulf Region By Sam Salek, PhD, RPH, FFPM, MRPSGB, Reem Al-Essa, BPharm, MBA, PhD, and Stuart Walker, PhD, MFPM, FIBiol, FRSC - Published 01 November 2012

The reality is many developing countries cannot ensure the safety, efficacy and quality of medicines available on their markets because of limitations in staffing, standard systems and training. Conversely, in developed countries where resources are less an issue, the primary focus of regulatory agencies of protecting public health is claimed to be shifting to encouraging the development of the pharmaceutical industry. This article discusses the role of harmonization, its advantages and disadvantages in the Gulf region.

Categories: Features, Asean, APEC

Tags: SADC, GCC, RHI, PANDRH, GCG, Gulf, Regulatory Harmonization, regulatory

Topic of Regulation Central to APEC Meeting By Alexander Gaffney - Published 14 February 2012

Categories: APEC

Tags: Russia, Cooperation, Asia-Pacific, Latest News, regulation, regulatory

APEC Affirms Role and Importance of Regulatory Reform in 2012 By Alexander Gaffney - Published 03 January 2012

Categories: APEC, OECD

Tags: Cooperation, Asia-Pacific, Latest News, regulation, regulatory