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.

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.

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.

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.

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.

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.

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

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

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.

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