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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

Future Regulatory Initiative for Opioids

Future Regulatory Initiative for Opioids

Opioids are narcotic pain relieving medications and are commonly prescribed in North America for acute and chronic pain. However, in addition to its therapeutic effects, opioids carry various side effects including increasing tolerance and the potential for dependence and overdose, which can be fatal.

Changes to Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)

Changes to Submission Filing Requirements - Good Manufacturing Practices (GMP)/Drug Establishment Licences (DEL)

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).

The Journey towards Safe Food for Canadians

The Journey towards Safe Food for Canadians

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.

Natural Health Product Research Society (NHPRS) of Canada hosts 14th annual conference, Beyond Tradition

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

Confidential Business Information Disclosure Update

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 A draft guidance document on the disclosure of CBI was published on Mar 10, 2016 and Health Canada underwent a consultation period.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

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

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

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.