Search Results for

Filtering on: "geography asia japan"

Showing 1 – 25  of 56

Is the Current Regulation of Autologous Stem Cells Appropriate? By Dr. Ian Prosser - Published 29 March 2017

This article discusses the regulation of autologous stem cells and tissue therapies in Australia by addressing issues such as the safety and efficacy of cell therapies, which therapies are regulated, what regulators are doing in other countries and "next steps" in cell and tissue regulation.

Categories: Features, Japan, Europe, Oceania, US, EMA, FDA, MHLW, PMDA, TGA, Human cell and tissue

Tags: Autologous Stem Cells

Establishing a Joint Venture Pharmaceutical Manufacturing Entity in Japan By Satoshi Koike, PhD, DSc - Published 23 March 2017

This article focuses on key regulatory activities to establish a Joint Venture (JV) for pharmaceutical manufacturing and sales in Japan. The author describes foundation building, marketing authorization holder responsibilities, new drug applications, clinical trial sponsorship, adverse events reporting and brand name registrations as well as requirements for data archiving and post-marketing regulatory activities.

Categories: Features, Japan, MHLW, PMDA, Biologics and biotechnology, Clinical, Drugs, Postmarket surveillance, Submission and registration

Tags: Common Technical Document, CTD

PMDA Head Talks Priorities for 'Rational Medicine' By Michael Mezher - Published 10 February 2017

The head of Japan's Pharmaceuticals and Medical Devices Agency (PMDA), Tatsuya Kondo, on Thursday released a paper discussing his vision for a patient-centric, regulatory science-driven and evidence-based system for medicine in Japan.

Categories: News, Japan, MHLW, PMDA, Biologics and biotechnology, Drugs, Medical Devices, Postmarket surveillance

Tags: Tatsuya Kondo, Rational Medicine, Regulatory Science

FDA Warns One Japanese, One Chinese Drugmaker By Michael Mezher - Published 18 January 2017

The US Food and Drug Administration (FDA) on Tuesday released warning letters sent to Japanese drugmaker Sato Yakuhin Kogyo Co. Ltd. and Chinese drugmaker Suzhou Pharmaceutical Technology Co., Ltd. earlier this month.

Categories: News, China, Japan, US, FDA, Active pharmaceutical ingredients, Compliance, Drugs, Manufacturing, Quality

Tags: Warning Letter, Data Integrity, Import Alert

FDA Warns Japanese API Maker Over Data Integrity Issues By Michael Mezher - Published 15 November 2016

The US Food and Drug Administration (FDA) on Tuesday released a warning letter sent to Japanese active pharmaceutical ingredient (API) maker Sekisui Medical Co., Ltd. for a series of data integrity issues at the company's Iwate, Japan site.

Categories: News, Japan, US, FDA, Active pharmaceutical ingredients, APIs, Manufacturing

Tags: Data integrity

RAPS Regulatory Convergence - 2016 Hot Topic Review By Sara Bobbit - Published 09 November 2016

This article provides a round-up of hot topics presented at this year's RAPS Regulatory Convergence and includes a high level recap of several sessions covering innovation and technology, Zika, real world evidence, patient access to innovative medicines and recent developments in off-label promotion.

Categories: News, Japan, Europe, US, FDA, MHLW, PMDA, Advertising and Promotion, Biologics and biotechnology, Clinical, Communication, Drugs, Labeling, Medical Devices, Research and development, Submission and registration

Tags: Regulatory Convergence, 2016 RAPS

Global Regulatory Strategy By Prerna Menon - Published 11 October 2016

This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.

Categories: Features, Japan, Canada, Europe, US, EMA, FDA, Health Canada, MHLW, PMDA, Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration

Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake

EU, Japan to Share More Information on GMP Inspections By Zachary Brennan - Published 05 October 2016

The European Directorate for the Quality of Medicines and Healthcare (EDQM) this week announced a new agreement with Japanese authorities to share more information on the outcome of good manufacturing practice (GMP) inspections of manufacturing sites of active pharmaceutical ingredients (APIs) of interest to both Europe and Japan.

Categories: News, Japan, Europe, EMA, MHLW, PMDA, Government affairs, Manufacturing

Tags: mutual recognition of GMP inspections, EMA and PMDA, Pharmacopoeia

FDA, EMA, PMDA Begin Push for New Antibacterials By Michael Mezher - Published 08 September 2016

The US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) met at EMA headquarters in London last week to discuss their role in promoting the development of new antibacterial products.

Categories: News, Japan, Europe, US, EMA, FDA, PMDA, Clinical, Drugs, Preclinical, Regulatory strategy, Research and development

Tags: Antimicrobial resistance, AMR

Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London By Zachary Brennan - Published 06 September 2016

If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.”

Categories: News, Japan, Europe, EC, EMA, MHRA, Biologics and biotechnology, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: EMA, Brexit, UK approval of drugs

Medical Food & Food for Special Medical Purposes: Global Regulatory Challenges and Opportunities By Manfred Ruthsatz, PhD, Timothy Morck, PhD - Published 01 September 2016

This article addresses current worldwide regulatory challenges and practical opportunities for medical food/Food for Special Medical Purpose (FSMP) to improve the role of nutrition in support of optimal care for patients. It presents the regulatory framework governing this specific category in the US, EU and other parts of the world.

Categories: News, Africa, China, India, Japan, Canada, Europe, Middle East, Oceania, US, FDA, Nutritional and dietary supplements

Tags: Medical Food, Food for Special Medical Purposes

eCTD: Journey Through the Decade By Pallavi Trivedi, Sharad Trivedi - Published 21 July 2016

This article discusses transitioning and implementing the electronic Common Technical Document (eCTD) in different regions a decade after its conceptualization. The article further discusses its impact on dossier compilation and document design practices as well as challenges faced by the pharmaceutical industry for effective lifecycle management.

Categories: News, Japan, Canada, Europe, US, Submission and registration

Tags: Electronic Common Technical Document, eCTD

Accelerating Global Submissions with a Six-Point eCTD Strategy By Steven Dowdley, Chet Shemanski - Published 05 July 2016

This article discusses how an integrated, six-point electronic Common Technical Document (eCTD) publishing strategy can accelerate global submissions and enhance the efficiency of regulatory operations. In addition, it outlines challenges specific to: large companies with a well-established, eCTD-compliant publishing capacity, but may lack strategic agility; and smaller companies with limited eCTD resources and expertise.

Categories: Features, Japan, Canada, Europe, US, FDA, Drugs, Regulatory strategy, Submission and registration

Tags: eCTD, Electronic Submissions, Common Technical Document

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

New ISO 13485: Device Companies Have Three Years to Transition By Michael Mezher - Published 01 March 2016

The International Organization for Standardization (ISO) late last month released its long-awaited revision to ISO 13485, the global standard for medical device quality management systems (QMS), which replaces the previous version from 2003.

Categories: News, Japan, Canada, Europe, Oceania, US, ISO, Medical Devices, Quality

Tags: ISO 13485, ISO 13485:2003, ISO 13485:2016, Quality Management Systems, QMS

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: AHWP to Harmonize Device Submissions in Asia (10 November 2015) By Nick Paul Taylor - Published 10 November 2015

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

Categories: News, Asean, China, Japan, Taiwan, Oceania, CFDA, TGA, Biologics and biotechnology, Drugs, Manufacturing, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy, Research and development

Tags: AHWP, Asia medical device submission, CFDA, WTO, TFDA, TGA

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

ICH Makes Organizational Changes By Zachary Brennan - Published 26 October 2015

The International Conference on Harmonisation (ICH) has renamed itself as the International Council for Harmonisation (ICH) and has now become a legal entity under Swiss law.

Categories: News, Japan, Canada, Europe, US, EMA, FDA, PMDA, Drugs, Government affairs, Quality, Regulatory intelligence, Regulatory strategy

Tags: ICH, PhRMA, EFPIA, PMDA, EMA, FDA

Asia Regulatory Roundup: India Looks to Raise Drug Inspection Standards (20 October 2015) By Nick Paul Taylor - Published 20 October 2015

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

Categories: News, India, Japan, Middle East, Oceania, CDSCO, PMDA, TGA, Drugs, Manufacturing, Quality, Regulatory intelligence, Regulatory strategy

Tags: CDSCO, DRAP, Pakistan, India, DCGI, marijuana, Australia

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: TGA Signs up for Pilot Project to Harmonize Medical Device Submissions (29 September 2015) By Nick Paul Taylor - Published 29 September 2015

Australia's Therapeutic Goods Administration (TGA) has joined a pilot project to harmonize the electronic submission format for the premarket evaluation of medical devices. TGA's participation in the pilot means companies can now use the Table of Contents (ToC) structure for supporting data when filing applications for conformity assessment with the Australian regulator.

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

Tags: Asia Regulatory Roundup, Regulatory Roundup

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: CFDA Starts Hiring Reviewers as Backlog-Control Strategy Kicks In (1 September 2015) By Nick Paul Taylor - Published 01 September 2015

China Food and Drug Administration (CFDA) has started recruiting 69 people to help with the review of submissions it receives from biopharma companies. The hiring coincides with attempts by CFDA to bring its ever-growing backlog of applications under control.

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

Tags: Regulatory Roundup, Asia Regulatory Roundup