Welcome to the CAPRA Blog
Planning to File Your 505(b)(2) Product in Canada?
Canada may not be top of the list of countries that companies target for first registration of their product (although it may be for orphan drugs – however, that’s a subject for another day!), but it’s usually in the next tier after USA and Europe, since typically Canada represents about 10% of the market size of the USA.
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.
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
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 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
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”
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
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
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
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?
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
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