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Filtering on: "geography canada"

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Regulatory Recon: UK Supreme Court Rules in Favor of Lilly Patents; HHS OIG Probes Alexion (7 July 2017) By Zachary Brennan - Published 07 July 2017

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

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

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

Novo Nordisk Warns of Possible Cracks in Insulin Devices By Zachary Brennan - Published 05 July 2017

Novo Nordisk A/S on Wednesday warned people with diabetes that it has detected that the insulin cartridge holder used in a select number of NovoPen Echo and NovoPen 5 lots may crack or break if exposed to certain chemicals, including certain cleaning agents.

Categories: News, Canada, US, Crisis management, Due Diligence, Medical Devices

Tags: Novo Nordisk, insulin pen, insulin device, NovoPen Echo, NovoPen 5

Pediatric Legislation, Quality Certificates, Global Regulatory Oversight, Biosimilars and a Preview of July By Gloria Hall - Published 05 July 2017

Feature articles over the past several weeks have highlighted global pediatric activities, certificates for small molecule drug products, the New Drug Application (NDA) process in Egypt and the global debate over naming biological products and biosimilars.

Categories: Features, Africa, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, MHLW, TGA, WHO, Biologics and biotechnology, Clinical, Drugs, Medical Devices, Regulatory intelligence, Submission and registration

Tags: Regulatory Focus, Feature Articles

Health Canada Opens Consultation on Mandatory Adverse Drug Reaction, Device Incident Reports By Zachary Brennan - Published 28 June 2017

Health Canada on Tuesday opened up a consultation on changes to the country's Food and Drug Regulations and Medical Devices Regulations that would make it mandatory for certain health care institutions to report serious adverse drug reactions (ADRs) and medical device incidents (MDIs).

Categories: News, Canada, Health Canada, Drugs, Government affairs, Medical Devices, Postmarket surveillance

Tags: Health Canada, Vanessa's Law, adverse event reporting

Biological Products and Biosimilars: Global Naming Debate By Pallavi Trivedi - Published 27 June 2017

This article presents the contrasting views and continuing debate among health authorities in Australia, Canada, Europe, Japan and the US as well as industry experts regarding conventions for naming biological products and biosimilars. It discusses the World Health Organization's (WHO's) proposal for naming and the importance of a clear distinction between the drugs to avoid confusion and ensure patient safety.

Categories: News, Asia, Canada, Europe, Oceania, US, EMA, FDA, Health Canada, PMDA, TGA, WHO, Biologics and biotechnology, Submission and registration

Tags: Biosimilars, Biosimilar Naming, Biological Qualifier, INN

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

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

Health Canada to Fully Implement ICH GCP Addendum in 2018 By Michael Mezher - Published 30 May 2017

Health Canada on Tuesday announced that it plans to fully implement an addendum to the International Council for Harmonisation's (ICH) good clinical practice (GCP) guideline in April 2018.

Categories: News, Canada, Health Canada, ICH, Clinical

Regulatory Recon: WHO Hosts 70th World Health Assembly; AstraZeneca Sells Rights to Heart Drug for $300M (22 May 2017) By Zachary Brennan - Published 22 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, Latin America and Caribbean, US, FDA, MHLW, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

Regulatory Recon: FDA Expands Use of CF Drug; ASCO Abstracts Released (18 May 2017) By Zachary Brennan - Published 18 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: Canada, Europe, US, FDA, Health Canada, Biologics and biotechnology, Drugs, Medical Devices

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

Canada Proposes to Amend Drug Pricing Regulations By Zachary Brennan - Published 17 May 2017

For the first time in more than two decades, Canada’s government is looking to amend its drug pricing regulations to better protect Canadians from paying excessive prices for patented drugs.

Categories: News, Canada, US, FDA, Health Canada, NICE, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy, Research and development

Tags: drug pricing, Canada drug prices, QALY, PMPRB, generic drugmakers

WHO Officials Offer Opposition to Value-Based Drug Pricing By Zachary Brennan - Published 12 May 2017

World Health Organization (WHO) officials told press in a briefing on Thursday that the agency has serious reservations with value-based pharmaceutical pricing systems.

Categories: News, Asia, Canada, Europe, US, NICE, WHO, Biologics and biotechnology, Drugs, Government affairs

Tags: WHO on drug pricing, fair pricing forum, pharmaceutical pricing

Regulatory Recon: French Regulators Halt ALS Trial; FDA Revisits Opioid Prescriber Training (12 May 2017) By Zachary Brennan - Published 12 May 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, CFDA, EMA, FDA, MHRA, NICE, WHO, Biologics and biotechnology, Drugs, Medical Devices

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

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

Health Canada to go eCTD-only for Drug Applications By Michael Mezher - Published 25 April 2017

Beginning on 1 January 2018, Health Canada will only accept submissions for certain regulatory procedures in electronic common technical document (eCTD) format.

Categories: News, Canada, Health Canada, Drugs, Submission and registration

Tags: Electronic Common Technical Document, eCTD

IMDRF Offers New Guideline on Adverse Event Reporting By Zachary Brennan - Published 10 April 2017

As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.

Categories: News, Asia, Canada, Europe, US, IMDRF, Compliance, In vitro diagnostics, Medical Devices, Postmarket surveillance, Quality

Tags: adverse events for medical devices, IMDRF guideline, GHTF

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

Regulatory Recon: Alexion to Lay Off More Than 200; FDA Approves Novartis Breast Cancer Treatment (14 March 2017) By Zachary Brennan - Published 14 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Asia, Canada, Europe, US, DOJ, EC, EMA, FDA, Health Canada, MHRA, NICE, Biologics and biotechnology, Drugs, In vitro diagnostics, Medical Devices

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

Regulatory Recon: Roche and Mylan Settle Dispute Over Herceptin Biosimilar; EMA Suspends Marketing of Four Contrast Agents for MRI Images (13 March 2017) By Zachary Brennan - Published 13 March 2017

Welcome to Regulatory Recon, a daily regulatory news and intelligence briefing.

Categories: News, Canada, Europe, US, EMA, FDA, Biologics and biotechnology, Drugs, Government affairs, Medical Devices

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

Canada to Require Drugmakers to Publicly Disclose Drug Shortages By Zachary Brennan - Published 13 March 2017

Beginning on Tuesday, 14 March, amendments to Canada’s Food and Drug Regulations will come into force making it mandatory for drug authorization holders to publicly report drug shortages and discontinuations to two websites, DrugShortagesCanada.ca and PenuriesDeMedicamentsCanada.ca.

Categories: News, Canada, Health Canada, Business and Leadership, Drugs, Ethics, Government affairs

Tags: drug shortages, Food and Drug Regulations

Pharmaceutical Inspection Co-operation Scheme Offers New Strategic Plan Through 2019 By Zachary Brennan - Published 08 March 2017

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week unveiled a new road map for the next two years during its February meeting in Switzerland, which was attended by representatives of 37 of its regulatory authorities.

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, Drugs, Government affairs, Manufacturing

Tags: PIC/S, GMP guidelines, regulatory affairs

Pharma Inspection Co-operation Scheme Criticizes Plan to Lower GMP Requirements for ATMPs By Zachary Brennan - Published 06 March 2017

The regulatory group known as the Pharmaceutical Inspection Co-operation Scheme (PIC/S) said in a letter released this week that it is “unanimously concerned” about the public health and safety impact of a new European Commission guideline that would lower good manufacturing practice (GMP) requirements for advanced therapy medicinal products (ATMPs).

Categories: News, Asia, Canada, Europe, US, EC, FDA, Health Canada, MHRA, TGA, WHO, Crisis management, Government affairs, Manufacturing

Tags: PIC/S, good manufacturing practice for ATMP, European Commission consultation

IMDRF Offers a Preview of Next Week’s Vancouver Meeting By Zachary Brennan - Published 06 March 2017

Members of the International Medical Device Regulators Forum (IMDRF) will meet next week in Vancouver for the group’s 11th meeting. Presentations on updates from members located in the US, EU, Brazil, Australia, as well as updates on IMDRF working groups were unveiled recently.

Categories: News, Asia, Canada, Europe, US, Anvisa, EC, FDA, IMDRF, TGA, WHO, Medical Devices, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: IMDRF, MDR, IVDR, MDUFA, Cures

International Generic Drug Regulators Unveil New Biowaiver Assessment Template By Zachary Brennan - Published 01 March 2017

Regulatory authorities participating in the International Generic Drug Regulators Programme (IGDRP) have crafted and released a Biopharmaceutics Classification System (BCS) Biowaiver Assessment Report template for use by its members.

Categories: News, Asia, Canada, Europe, US, CFDA, EMA, FDA, Health Canada, WHO, Generic drugs, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: IGDRP, biowaivers, Biopharmaceutics Classification System

Democrats Revive Canada Drug Import Bill as Safety Questions Linger By Zachary Brennan - Published 28 February 2017

Sens. Bernie Sanders (D-VT) and several colleagues who previously opposed such a measure, Cory Booker (D-NJ), Bob Casey (D-PA), Martin Heinrich (D-NM), Angus King (I-ME), alongside Reps. Elijah Cummings (D-MD) and Lloyd Doggett (D-TX) on Tuesday revived legislation lingering for more than a decade to allow the importation of medicines from Canada and other countries to help lower US drug prices.

Categories: News, Canada, US, FDA, Biologics and biotechnology, Drugs, Government affairs

Tags: Canada pharmaceutical imports, Bernie Sanders, drug costs, Rx import bill