Tag archives: Regulatory

Drug pricing: PMPRB releases scoping paper to consult on new Guidelines

By Christopher A. Guerreiro and Kristin Wall on November 12, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has released a scoping paper on themes and questions to develop new price review Guidelines. The scoping paper also includes information on how stakeholders can participate in the consultation. The deadline for written submissions addressing the scoping paper is December 20, 2023. Background The PMPRB has not had a … Continue reading

Ontario proposes removing barrier to listing “well-established drugs” on its public formulary

By Julia Won, Paul Jorgensen and Kristin Wall on November 5, 2023 Posted in Pharmaceuticals and life sciences

On October 19, 2023, the Ontario government proposed regulatory amendments that may eliminate the need to submit certain clinical studies and evidence when requesting that a “well-established drug” be (i) listed or (ii) designated as interchangeable on Ontario’s publicly-funded formulary. The government is seeking feedback on the proposed amendments. Background A manufacturer can apply to … Continue reading

Drug pricing: PMPRB announces framework for new guidelines consultation

By Christopher A. Guerreiro and Kristin Wall on October 26, 2023 Posted in Pharmaceuticals and life sciences

The Patented Medicine Prices Review Board (PMPRB) has announced a framework for the launch of its consultation on new guidelines, beginning with a scoping paper to be published in advance of Policy Roundtable sessions to be held December 5 (English) and December 6 (French), 2023. The PMPRB has not had a full set of guidelines … Continue reading

Drug reimbursement: CADTH publishes procedures on time-limited reimbursement

By Sarah Pennington, Christopher A. Guerreiro and Kristin Wall on October 24, 2023 Posted in Pharmaceuticals and life sciences

Canada’s Drug and Health Technology Agency (CADTH) has published its procedures for a new time-limited reimbursement recommendation category. This recommendation category is intended to help provide earlier access to new therapies for severe, rare, or debilitating conditions where there is an unmet medical need. The pathway includes mechanisms to revisit the clinical and economic evidence … Continue reading

Health Canada consulting on wide-ranging regulatory amendments for drugs and medical devices

By John Greiss, Paul Jorgensen and Kristin Wall on January 19, 2023 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has launched a consultation on proposed amendments to the Food and Drug Regulations and Medical Devices Regulations (the Regulatory Amendments). Consultation on the Regulatory Amendments, which have been published in the Canada Gazette, Part 1, is open until March 27, 2023. The Regulatory Amendments build upon the regulatory flexibilities introduced in the Interim … Continue reading

Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

By Sarah Pennington and Kristin Wall on August 9, 2021 Posted in Life sciences and healthcare

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations (FDR) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market. … Continue reading

Proposed amendments to the PM(NOC) Regulations: Patents claiming different salt forms of medicinal ingredients eligible for inclusion on the Patent Register

By David Yi, Kristin Wall and Pharma in Brief team on April 25, 2021 Posted in Intellectual property, Life sciences and healthcare, Pharmaceuticals and life sciences

On April 23, 2021, Proposed PM(NOC) Amendments [1] were published in the Canada Gazette, Part I. These amendments permit patents claiming different forms of a medicinal ingredient (e.g., salt forms) to be listed on the patent register and are intended to balance Proposed FDR Amendments [2] published on March 30, 2019 which allow generic manufacturers … Continue reading

Health Canada consults on transition of interim order drugs, vaccines, and medical devices to permanent approval pathways

By John Greiss and Kristin Wall on December 3, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

As we have previously reported, the Minister of Health (Minister) approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (Interim Order for Drugs and Vaccines) on September 16, 2020 and the Interim order respecting the importation and sale of medical devices for use in relation to … Continue reading

New Interim Order to expedite the approval of COVID-19 drugs and vaccines

By John Greiss and Kristin Wall on September 22, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

On September 16, 2020, the Minister of Health signed an Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19 (the Interim Order) which provides new regulatory pathways to expedite the approval of COVID-19 drugs and vaccines that have not yet been approved for sale in Canada. It also … Continue reading

Health Canada releases Guidance Document addressing the Plain Language Labelling Regulations requirements for non-prescription drug products

By Sarah Pennington, John Greiss and Randy Sutton on April 15, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada recently published a new Guidance Document that provides information on how Health Canada interprets and applies the 2014 Regulations Amending the Food and Drug Regulations (Labelling, Packaging and Brand Names of Drugs for Human Use) (colloquially known as the Plain Language Labelling Regulations or PLL Regulations) for non-prescription (i.e. over-the-counter or OTC) drug … Continue reading

Health Canada issues Interim Order to address shortages of health products

By John Greiss, Randy Sutton and Brian R. Daley on April 13, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada has published an Interim Order Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19 (the Interim Order). This Interim Order allows Health Canada and the Canadian Food Inspection Agency to address critical supply issues in an expedited manner when shortages occur. It was signed by the Minister … Continue reading

Ontario and Quebec Introduce Changes to Pharmacy Practice and Highlight the Drug Supply Chain as an Essential Service

By John Greiss, Randy Sutton and Brian R. Daley on March 25, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Changes Affecting Ontario The Government of Ontario has made changes to the Ontario Drug Benefit (ODB) Program in an effort to reduce the risk of drug shortages in the province during the COVID-19 outbreak. Effective immediately, ODB eligible drugs are subject to the following changes to rules on dispensing and fees: The dispensing of medication … Continue reading

COVID-19: Health Canada simplifies regulatory requirements for COVID-19-related products

By John Greiss, Randy Sutton and Kristin Wall on March 22, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

Health Canada is taking measures to help expedite the importation and sale of certain licensed products required to combat COVID-19. Expedited review of Health Product Submissions and Applications Health Canada has announced that it will expedite the review of any COVID-19 related vaccines, therapeutic products and other health product submissions and applications. Until a vaccine … Continue reading

COVID-19: Sharing information for licensed health products during a pandemic

By John Greiss, Kristin Wall and Randy Sutton on March 17, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The public health call for social distancing to help curb the COVID-19 pandemic has no doubt already affected how companies will be sharing information about pharmaceuticals and other licensed health products with healthcare professionals (HCPs), patients, and the public. As industry plays its part in keeping sales representatives and medical science liaisons (MSLs) home to … Continue reading

COVID-19: Health Canada Issues Bulletin Confirming Obligations of DEL Holders

By John Greiss and Randy Sutton on March 5, 2020 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

In light of recent developments relating to the to the 2019 novel coronavirus (COVID-19), Health Canada recently sent a reminder to all Drug Establishment License (DEL) holders of their obligations under the Food and Drug Regulations (FDR) regarding reporting of events that could affect operations and lead to shortages or issues affecting quality, safety, and … Continue reading

Ontario reduces restrictions on ordinary commercial term benefits and private label products

By William Chalmers, Randy Sutton and Allyson Whyte Nowak on December 17, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Ministry of Health and Long-Term Care (the Ministry) introduced changes to regulations (collectively, the Regulations) made under the Ontario Drug Benefit Act (ODBA) and the Drug Interchangeability and Dispensing Fee Act (DIDFA). These changes will remove the financial caps on ordinary commercial term (OCT) payments made by drug manufacturers to pharmacies and allow … Continue reading

Ontario consults on changes to streamline drug formulary listing and reduce government payments to pharmacies

By William Chalmers and Kristin Wall on November 10, 2019 Posted in Life sciences and healthcare, Pharmaceuticals and life sciences

The Ontario Ministry of Health and Long-Term Care (the Ministry) has proposed draft amendments to Regulations made under the Ontario Drug Benefit Act (ODBA) and the Ontario Drug Interchangeability and Dispensing Fee Act. The proposed changes are intended to reduce technical requirements for listing a product on the Ontario formulary and align policies with industry … Continue reading