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Filtering on: "geography oceania"

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Asia Regulatory Roundup: J&J, Medtronic Lead Pushback Against TGA Device Priority Review Proposal (20 June 2017) By Nick Paul Taylor - Published 20 June 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

Tags: Asia Regulatory Roundup, Regulatory Roundup

WHO to Craft Essential Diagnostics List By Zachary Brennan - Published 16 June 2017

The World Health Organization (WHO) has received a recommendation from an expert committee to develop an Essential Diagnostics List (EDL).

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, WHO, Due Diligence, Government affairs, In vitro diagnostics, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: WHO essential diagnostics, EDL, Essential medicines list

Australia Proposes New Risk-Based Approach to Medicine Variations By Zachary Brennan - Published 08 June 2017

Australia's Therapeutic Goods Administration (TGA) on Thursday released guidance on a plan to allow companies to make "very low risk" changes to registered medicines after submitting them to TGA and receiving an automated acknowledgement.

Categories: News, Oceania, TGA, Drugs, Regulatory intelligence, Regulatory strategy

Tags: medicines variations, low-risk medicines variations, drug changes

Asia Regulatory Roundup: CFDA Ordered More Inspections of Foreign Manufacturers in 2016, But Visited Fewer Sites (6 June 2017) By Nick Paul Taylor - Published 06 June 2017

The China Food and Drug Administration (CFDA) has released a breakdown of the good manufacturing practice (GMP) inspections it performed last year. The report shows another year of growth in the number of inspections of overseas manufacturers ordered by CFDA, yet the agency only performed a fraction of these planned visits.

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Manufacturing, Medical Devices, Postmarket surveillance

Tags: Regulatory Roundup, Asia Regulatory Roundup

Quality Certificates for Small Molecule Drug Product Applications for International Regulatory Submissions By Monika Jain, PhD - Published 02 June 2017

This article provides a global overview of the general requirements and issues regulatory professionals may encounter while arranging for a variety of certificates for applications for small molecule drug products to be marketed internationally in the EU, US, Canada, Australia and Japan.

Categories: Features, Japan, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, Drugs, Submission and registration

Tags: Quality Certificates, eCTD, GMP

Asia Regulatory Roundup: CFDA Seeks to Exempt More Devices From Clinical Trials (23 May 2017) By Nick Paul Taylor - Published 23 May 2017

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Government affairs, Manufacturing, Medical Devices

Tags: Asia Regulatory Roundup, NPPA, medical device exemptions, PIC/S

Australia Considers Allowing the Marketing of Devices Approved Overseas By Zachary Brennan - Published 22 May 2017

Australia’s Therapeutic Goods Administration (TGA) on Monday unveiled a plan to further converge its medical device regulations with those from comparable overseas regulators and allow for the use of devices that have received marketing approvals from some foreign authorities.

Categories: News, Oceania, TGA, Government affairs, Medical Devices, Regulatory intelligence, Regulatory strategy

Tags: Australia's TGA, medical devices in Australia, conformity assessments, regulation of devices

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

Asia Regulatory Roundup: TGA Plans to Bolster its Punishment Powers (9 May 2017) By Nick Paul Taylor - Published 09 May 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, Government affairs, Medical Devices

Tags: NPPA, codeine, pharmaceutical advertising, stent price

TGA to Move Forward With Orphan Drug Revamp By Michael Mezher - Published 18 April 2017

Australia's pharmaceutical industry is "broadly supportive" of proposed changes to the country's orphan drug program, the Therapeutic Goods Administration (TGA) says.

Categories: News, Oceania, TGA, Biologics and biotechnology, Drugs, Orphan products, Regulatory strategy, Submission and registration

Tags: Orphan Drugs, Australia

Regulatory Business and Strategy, Medical Device Regulations, Adverse Event Reporting Requirements and a Preview of April By Gloria Hall - Published 05 April 2017

The following is a summary of feature articles posted over the past weeks with links and a preview of what's to come in April.

Categories: Features, Asia, Europe, Oceania, US, EC, FDA, Business Skills, Human cell and tissue, Medical Devices

Tags: Features, Regulatory Focus

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

Asia Regulatory Roundup: CFDA Offers Technical Guidance on Clinical Trials (24 January 2017) By Nick Paul Taylor - Published 24 January 2017

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Clinical, Drugs, Medical Devices

Tags: Asia Regulatory Roundup, clinical trial guidance, import licenses, advisory committees

Asia Regulatory Roundup: China Unveils Reforms to Simplify Supply Chains, Lower Drug Costs (18 January 2017) By Nick Paul Taylor - Published 18 January 2017

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

Categories: News, China, India, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

Tags: Asia Regulatory Roundup, Regulatory Roundup

Regulatory Recon: CRISPR Gene Editing Tested in First Person; Republicans Tell US Federal Agencies to Stop Work on Regulations Until Trump Takes Office (16 November 2016) By Zachary Brennan - Published 16 November 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Middle East, Oceania, US, DOJ, EMA, FDA, FTC, MHRA, NICE, PMDA, TGA, Biologics and biotechnology, Business and Leadership, Clinical, Drugs, Government affairs, Medical Devices, Quality, Regulatory intelligence, Regulatory strategy

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

Asia Regulatory Roundup: CFDA Begins Verifying Trial Data (8 November 2016) By Nick Paul Taylor - Published 08 November 2016

China's Food and Drug Administration (CFDA) has verified data generated in clinical trials sponsored by AstraZeneca, Johnson & Johnson and Sanofi among the first batch of 55 clinical trials to be verified by the regulator under its data audit initiative.

Categories: News, China, Oceania, CFDA, TGA, Biologics and biotechnology, Generic drugs, Medical Devices, Nutritional and dietary supplements, Submission and registration

Tags: Asia Regulatory Roundup, Regulatory Roundup

Australia’s TGA Looks to Mirror US FDA, EMA With Two New Expedited Drug Approval Pathways By Zachary Brennan - Published 31 October 2016

As part of an attempt to catch up with the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Health Canada, Australia’s Therapeutic Goods Administration (TGA) on Monday released five new consultations for public comment, including one that would forge new priority review and provisional approval pathways.

Categories: News, Oceania, EMA, FDA, Health Canada, TGA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices, Preclinical, Regulatory intelligence, Regulatory strategy

Tags: faster drug approval, accelerated approval, priority review for drugs, international drug regulators

Regulatory Recon: Astellas to Buy Ganymed for up to $1.4B; Sanofi, Novo Nordisk Fortunes Diverge (28 October 2016) By Zachary Brennan - Published 28 October 2016

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

Categories: News, Asia, Europe, Oceania, US, CFDA, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices

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

Pharmaceutical Regulators Propose Principles for Indication Extrapolation for Biosimilars By Zachary Brennan - Published 06 September 2016

The International Pharmaceutical Regulators Forum’s (IPRF) Biosimilars Working Group (BWG) on Tuesday released a reflection paper outlining principles that regulators around the world can use for extrapolating indication(s) during the authorization process for new biosimilars.

Categories: News, Africa, Asia, Canada, Europe, Latin America and Caribbean, Oceania, US, EMA, FDA, Health Canada, MHLW, MHRA, PMDA, TGA, WHO, Biologics and biotechnology, Government affairs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IPRF, biosimilar regulatory harmonization, biosimilar applicants, follow-on biologics

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

EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection By Zachary Brennan - Published 19 August 2016

A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHRA, TGA, Active pharmaceutical ingredients, Drugs, Manufacturing, Product withdrawl and retirement, Regulatory intelligence, Regulatory strategy

Tags: GMP inspection, Pfizer, India drug manufacturing, antibiotics manufacturing

Asia Regulatory Roundup: CFDA to Punish Clinical Trial Data Fraudsters (16 August 2016) By Nick Paul Taylor - Published 16 August 2016

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

Categories: News, Asia, Oceania, CFDA, TGA, Biologics and biotechnology, Crisis management, Drugs, Due Diligence, Regulatory intelligence, Regulatory strategy

Tags: Asia Regulatory Roundup, clinical trial fraud, metformin, drug manufacturing

Data Integrity: New Draft Guidance and Q&A By Zachary Brennan - Published 11 August 2016

The European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) on Thursday released new draft guidance and a question and answer document to help ensure that data integrity is maintained during the process of testing, manufacturing, packaging, distributing and monitoring medicines.

Categories: News, Africa, Asia, Canada, Europe, Middle East, Oceania, US, EMA, FDA, Active pharmaceutical ingredients, Business Skills, Drugs, Government affairs, Manufacturing, Regulatory intelligence, Regulatory strategy

Tags: PIC/S, data integrity of medicines during manufacturing, pharmaceutical manufacturing, GMP drug manufacturing

Australia Outlines Major Drug Label Changes By Zachary Brennan - Published 09 August 2016

Australia’s Therapeutic Goods Administration (TGA) on Tuesday announced upcoming changes to the way medicine labels on the island will look and be laid out in order to make more pertinent information about medicines easier to find.

Categories: News, Oceania, TGA, Active pharmaceutical ingredients, Drugs, Labeling, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: Australia drug labels, drug label, drug labeling changes, dispensing label

Asia Regulatory Roundup: India Revises Draft Biosimilar Guidance (5 July 2016) By Nick Paul Taylor - Published 05 July 2016

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

Categories: News, Asia, Oceania, CDSCO, CFDA, TGA, Biologics and biotechnology, Drugs, Due Diligence

Tags: Asia Regulatory Roundup, biosimilar guidance