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Summary on Recent Intellectual Property Hold for Notifiable Change Submissions

Summary on Recent Intellectual Property Hold for Notifiable Change Submissions

On April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards subsequent entry manufacturers and sponsors as per the Patented Medicines (Notice of Compliance) Regulations and the Food and Drug Regulations.

An Update on the Regulatory Progress of Biosimilars in Canada, the EU and the U.S.

An Update on the Regulatory Progress of Biosimilars in Canada, the EU and the U.S.

In the last 10 years, biosimilar regulatory guidelines have evolved significantly in Canada, the European Union (EU) and the United States of America (U.S.). Anchored on the patent expiration date, there is a wave of biosimilars development in Western countries as well as other countries – all demanding cheaper versions of biologic medicines for their citizens.

Plain Language Labelling Summary

Plain Language Labelling Summary

A few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada.

Health Canada Begins Consultations on Mandatory Reporting by Health Care Institutions

Health Canada Begins Consultations on Mandatory Reporting by Health Care Institutions

Health Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that would require mandatory reporting of serious adverse drug reactions and medical device incidents by health care institutions.

Patients and Philanderers: Why the Ashley Madison Report has Something Important to Say about Cybersecurity Standards for Patient Data

Patients and Philanderers: Why the Ashley Madison Report has Something Important to Say about Cybersecurity Standards for Patient Data

Privacy legislation in Canada, the U.S. and elsewhere, while imposing detailed requirements on issues such as consent, often reverts to high level principles in outlining privacy safeguards or security obligations.

ICH “Good Clinical Practice Renovation”

ICH “Good Clinical Practice Renovation”

On January 2017, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a reflection paper titled Good Clinical Practice Renovation: Modernization of ICH E8 and Subsequent Renovation of ICH E6. The reflection paper discusses current issues with the ICH guidelines regarding clinical trial design and conduct, and the need to update the guidelines to reflect current concerns.

Canadian Drug Establishment Licences: GMP Requirements for API foreign building

Canadian Drug Establishment Licences: GMP Requirements for API foreign building

Canada's Food and Drug Regulations (FDR) were amended to extend the requirements of Division 1A - Establishment Licensing and Division 2 - Good Manufacturing Practices (GMP) to active ingredients used in pharmaceutical drugs for human use only.

A Recap on Vanessa’s Law

A Recap on Vanessa’s Law

With the evolution of healthcare products and its regulations, today we will recap one of the most significant recent changes in Canadian regulations; Vanessa’s Law.

Changes to the Annual Renewal Process of Canadian Drug Establishment Licences

Changes to the Annual Renewal Process of Canadian Drug Establishment Licences

Effective 2017 Annual Licence Renewal (ALR) of Drug Establishment Licences (DEL), Health Canada has added an extra step to the ALR submission process by DEL holders. This change constitutes of an addition of a MS Excel sheet known as “Product List” and it has been provided to all the DEL holders along with the 2017 ALRs packages.

FDA’s eCTD Mandate: Are You Ready?

FDA’s eCTD Mandate: Are You Ready?

When FDA posted their eCTD mandate last year, it was more of a whisper than a bang. It certainly did not wreak havoc in the industry; after all, we were all warned that the time would come sooner rather than later.

Information on the new Access to Cannabis for Medical Purposes Regulations

Information on the new Access to Cannabis for Medical Purposes Regulations

On August 11, 2016, Health Canada announced the new Access to Cannabis for Medical Purposes Regulations (ACMPR) which came into force on August 24, 2016

Annual Drug Notification Form

Annual Drug Notification Form

The Annual Drug Notification Form (ADNF) is intended to assist manufacturers in complying with section C.01.014.5 of the Food and Drug Regulations which requires that every manufacturer of a drug confirms annually before October that all information previously supplied with regard to that drug is correct