Welcome to the CAPRA Blog
Summary on Recent Intellectual Property Hold for Notifiable Change Submissions
Author: Pinky Mazumder On April 7th, 2017, Health Canada released the Intellectual Property Hold for Notifiable Change Submissions notice. This notice is geared towards...
An Update on the Regulatory Progress of Biosimilars in Canada, the EU and the U.S.
Author: Oxana Iliach, PhD[1] , Raymond Huml MS, DVM, RAC1 Introduction In the last 10 years, biosimilar regulatory guidelines have evolved significantly in Canada, the...
Plain Language Labelling Summary
Author: Pinky Madhur A few years ago on June 13th, 2015, the Plain Language Labelling Regulations became effective for prescription drugs in Canada. This new regulation...
Health Canada Begins Consultations on Mandatory Reporting by Health Care Institutions
Author: Mark Vanderveken and Alanna Tevel Health Canada has commenced consultations on proposed changes to the Food and Drug Regulations and Medical Devices Regulations that...
Patients and Philanderers: Why the Ashley Madison Report has Something Important to Say about Cybersecurity Standards for Patient Data
Author: John Beardwood A) Introduction Privacy legislation in Canada, the U.S. and elsewhere, while imposing detailed requirements on issues such as consent, often reverts to...
ICH “Good Clinical Practice Renovation”
By: Pinky Mazumder On January 2017, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) released a reflection paper...
Canadian Drug Establishment Licences: GMP Requirements for API foreign building
Author: Madhur Jadawala Canada's Food and Drug Regulations (FDR) were amended to extend the requirements of Division 1A - Establishment Licensing and Division 2 - Good...
A Recap on Vanessa’s Law
Author: Pinkiy Mazumder With the evolution of healthcare products and its regulations, today we will recap one of the most significant recent changes in Canadian regulations;...
Changes to the Annual Renewal Process of Canadian Drug Establishment Licences
Author: Author Madhur Jadawala OVERVIEW Effective 2017 Annual Licence Renewal (ALR) of Drug Establishment Licences (DEL), Health Canada has added an extra step to the ALR...
FDA’s eCTD Mandate: Are You Ready?
Author: Anisah Bipatnath, M.Sc. Project Manager, Regulatory Operations When FDA posted their eCTD mandate last year, it was more of a whisper than a bang. It certainly did...
Information on the new Access to Cannabis for Medical Purposes Regulations
Author: Rachelle D’Souza On August 11, 2016, Health Canada announced the new Access to Cannabis for Medical Purposes Regulations (ACMPR) which came into force on August 24,...
Annual Drug Notification Form
Article by: Rachelle D’Souza, Regulatory Heights Inc. The Annual Drug Notification Form (ADNF) is intended to assist manufacturers in complying with section C.01.014.5 of the...
Future Regulatory Initiative for Opioids
Article by: Pinky Mazumder If you have been tuning in to recent Canadian news, you will have noticed various critiques and discussions around the use of opioids. In case you...
Changes to Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)
Article by: Madhur Jadawala, Lead Consultant, Quality & Compliance Services Inc. Health Canada on February 10, 2017 has issued a notice outlining changes to the submission...
The Journey towards Safe Food for Canadians
Article by: Carol T Culhane, PHEc, MBA, President, International Food Focus Ltd. With alarming food safety recalls across the nation, in January 21st 2017, the long-awaited...
Natural Health Product Research Society (NHPRS) of Canada hosts 14th annual conference, Beyond Tradition
The Natural Health Product Research Society (NHPRS) of Canada is pleased to host its 14th annual conference, Beyond Tradition, May 8-11, 2017, at the Pinnacle Hotel...
Confidential Business Information Disclosure Update
The Health Minister can disclose confidential business information (CBI) to protect or promote health or safety. A draft guidance document on the disclosure of CBI was...
Changes to the Foreign Site Expiry dates on Canadian Drug Establishment Licences
OVERVIEW Effective July 21, 2016, Health Canada has changed the expiry date for foreign building GMP renewal evidence to a NERBY (New Evidence Required By) date. WHO DOES...
Welcome To Regulated Affairs
We are excited to be launching a blog for The Canadian Association of Professionals in Regulatory Affairs (CAPRA)! Your source for timely information on news, events and...
Validation Rules for Regulatory Transactions Submitted in the electronic Common Technical Document (eCTD) Format
Author: Bhavesh Patel, C. Chem. Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document...