Health Canada on February 10, 2017 has issued a notice outlining changes to the submission filing requirements pertaining to Good Manufacturing Practices (GMP)/ Drug Establishment Licences (DEL). These changes are effective immediately for drug submissions filed after the date of this notice (February 10, 2017).

With alarming food safety recalls across the nation, in January 21st 2017, the long-awaited proposed regulations under the Safe Food for Canadians Act (SFCA), which received Royal Assent on November 22nd, 2012, was published in Canada Gazette I.

The Natural Health Product Research Society (NHPRS) of Canada is pleased to host its 14th annual conference, Beyond Tradition, May 8-11, 2017

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 A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.

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.

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.

Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.