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Filtering on: "geography canada"

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Regulatory Recon: Teva Warns on Profit Outlook; Hospitals Vow to Keep Medicare Drug Subsidies (2 November 2017) By Zachary Brennan - Published 02 November 2017

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

Categories: News, Canada, Europe, US, EMA, FDA, MHRA, Biologics and biotechnology, Drugs, Medical Devices, Regulatory intelligence, Regulatory strategy

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

MDSAP Changes Aim to Reduce Audit Times By Zachary Brennan - Published 30 October 2017

With an eye on a 1 January 2019 deadline for transitioning to only Medical Device Single Audit Program (MDSAP) quality management system certificates accepted for medical device license applications by Health Canada, the MDSAP consortium has implemented a couple of changes to speed up audits.

Categories: News, Canada, Health Canada, IMDRF, Government affairs, In vitro diagnostics, Medical Devices, Quality

Tags: MDSAP, quality management system audits, medical device audits

ISO: Identification of Medicinal Products Standards Revised By Zachary Brennan - Published 23 October 2017

The International Organization for Standardization (ISO) is revising a series of standards known as Identification of Medicinal Products (IDMP) standards as part of an effort to simplify the exchange of medicinal product information.

Categories: News, Canada, Europe, US, ISO, Compliance, Drugs, Government affairs

Tags: IDMP standards

ICH Transparency: New Info on Funding, Expert Working Groups By Zachary Brennan - Published 17 October 2017

The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded.

Categories: News, Asia, Canada, Europe, US, ICH, Biologics and biotechnology, Drugs, Regulatory intelligence, Regulatory strategy

Tags: ICH funding, E9, E11, S5

Health Canada Seeks to Update User Fees for Drug and Device Firms By Zachary Brennan - Published 13 October 2017

Health Canada this week opened for consultation a proposal to update and increase some of the fees it assesses for pharmaceutical and medical device companies, noting that the last update came in 2011 and was based on 2007 data.

Categories: News, Canada, Health Canada, Biologics and biotechnology, Drugs, Government affairs, Submission and registration, Veterinary products

Tags: pharmaceutical fees, medical device fees, Health Canada fees

Global Reimbursement Strategy, Advertising, Labeling and Marketing, and a Preview of Health Related Foods By Gloria Hall - Published 04 October 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 October.

Categories: Features, Canada, Europe, US, FDA, Health Canada, MHRA, NICE, Advertising and Promotion, Labeling, Nutritional and dietary supplements, Reimbursement

Tags: Regulatory Focus, Feature Articles, Editorial

FDA Offers New ICH Guidance on Organizing a CTD By Zachary Brennan - Published 04 October 2017

The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA.

Categories: News, Canada, Europe, US, FDA, ICH, Drugs, Regulatory intelligence, Regulatory strategy, Submission and registration

Tags: eCTD, common technical document, ICH guidance

Canada Reimbursement Profile By Matthew Brougham, MSc, William O'Neil, PhD, Dima Samaha, MAS, PharmD - Published 04 October 2017

This profile summarizes reimbursement processes in Canada, presents information for key stakeholders and highlights what should be considered early in the development process.

Categories: Features, Canada, Health Canada, Drugs, Medical Devices, Reimbursement

Tags: CADTH, Health Canada, INESSS, pCPA, PMPRB

IMDRF Consults on Use of Registries to Support Device Approval Decisions By Zachary Brennan - Published 02 October 2017

The International Medical Device Regulators Forum (IMDRF) has opened for consultation until 1 December a third document on examining the use of registries to support medical device regulatory decision making.

Categories: News, Asia, Canada, Europe, US, IMDRF, In vitro diagnostics, Medical Devices, Postmarket surveillance, Regulatory intelligence, Regulatory strategy

Tags: registry data and medical devices, medical device data, approval decisions and registries

MDSAP Update: Canada's 2019 Deadline Still on Track By Michael Mezher - Published 11 September 2017

Speaking at RAPS' 2017 Convergence on Monday, officials from two international regulators and representatives from auditing organizations offered the latest on the Medical Device Single Audit Program (MDSAP).

Categories: News, Japan, Canada, Latin America and Caribbean, Oceania, US, Anvisa, FDA, Health Canada, MHLW, PMDA, TGA, Medical Devices

Tags: MDSAP, Medical Device Single Audit Program

Drug Reimbursement in Canada By George Wyatt, MBA - Published 01 September 2017

This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place.

Categories: Features, Canada, Health Canada, Biologics and biotechnology, Drugs, Reimbursement

Tags: Reimbursement, Coverage, Health Technology Assessment, HTA, Common Drug Review

IPRF and IGDRP to Consolidate Regulatory Initiatives in 2018 By Zachary Brennan - Published 31 August 2017

The International Pharmaceutical Regulators Forum (IPRF) and International Generic Drug Regulators Programme (IGDRP) have agreed to consolidate their work into a joint initiative that is expected to be operational in January 2018.

Categories: News, Asia, Canada, Europe, US, EC, EMA, FDA, Health Canada, ICH, MHRA, WHO, Drugs, Regulatory intelligence, Regulatory strategy

Tags: IPRF, IGDRP, pharmaceutical regulations

EMA Opens Consultations of Two Revised ICH Guidelines By Zachary Brennan - Published 31 August 2017

The European Medicines Agency (EMA) on Thursday released for consultation a revised ICH guideline on reproductive toxicology and an addendum to another guideline on statistical principles for clinical trials.

Categories: News, Canada, Europe, US, EMA, ICH, Clinical, Drugs

Tags: ICH E9, ICH S5

The Value of Health Technology Assessment Scientific Advice By Amina Udechuku, PhD, Matthew William Bending, PhD, MSc - Published 23 August 2017

In recent years, particularly in Europe, a paradigm shift in the regulatory and Health Technology Assessment (HTA) environment has led to an increase in multi-stakeholder acceptance of integrated scientific advice. This article discusses how using integrated scientific advice can support companies in optimizing their product development programs and generate evidence relevant to regulators, HTA bodies and payers.

Categories: Features, Canada, Europe, US, EMA, FDA, NICE, Biologics and biotechnology, Drugs

Tags: Health Technology Assessment, HTA

Regulatory Recon: J&J Pays $417M for Baby Powder Link to Cancer (22 August 2017) By Zachary Brennan - Published 22 August 2017

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

Categories: News, Asia, Canada, Europe, US, EMA, FDA, Health Canada, MHRA, PMDA, WHO, Drugs, Government affairs, Medical Devices

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

New Research Compares Drug Regulators Around the Globe By Zachary Brennan - Published 11 August 2017

Pharmaceutical regulations vary widely in different countries, though new research published Friday in Nature Reviews Drug Discovery offers comparisons in terms of various regulators’ budgets, staff, new drug approvals and timelines for approvals.

Categories: News, Asia, Canada, Europe, US, Anvisa, CFDA, EMA, FDA, MHRA, PMDA, Government affairs, Regulatory intelligence, Regulatory strategy

Tags: comparison of drug regulators, new drug approval times, drug regulator reviewers

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