Welcome to the CAPRA Blog
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 A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.
Changes to the Foreign Site Expiry dates on Canadian Drug Establishment Licences
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.
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 updates in regulatory affairs in Canada.
Validation Rules for Regulatory Transactions Submitted in the electronic Common Technical Document (eCTD) Format
Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.