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
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
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