Does Health Canada give approvals based on foreign decisions?

IS IT TRUE THAT HEALTH CANADA BASES THEIR DECISIONS IN GREAT PROPORTIONS ON FOREIGN DECISIONS?

This is a major miss-conception. We have seen in many instances, new drugs or new indications approved in Canada while the approval was on hold or refused in foreign countries. Health Canada makes their own independent decisions. However, it is possible (and recommended) to submit the major Q & As issued during the foreign review, along with the Foreign Agency Reviewers Reports. If the submission includes foreign review report, it is recommended to include a completed Foreign Review Attestation Template. The extent to which Health Canada will use foreign reviews varies. The Canadian regulatory decision can be based on a critical assessment of the foreign reviews, on the Canadian review only or on a mixture of both.

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

SPharm Canada

With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.

Health Canada issues a new guidance GUI-0064

16 November 2016

Health Canada announces the issuance of a new Guidance GUI-0064: How Health Canada inspects medical device establishments. These guidelines will help anyone with a medical device establishment licence, understand and prepare for an inspection as well as to ensure that they are carried out in a consistent manner. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/compli-conform/info-prod/md-im/md_insp_prog-prog_insp_mm-eng.pdf

SPharm Canada

With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.

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What is a Drug Identification Number?

WHAT IS A DRUG IDENTIFICATION NUMBER? IS IT SPECIFIC TO CANADA?

A Drug Identification Number (DIN) is a unique eight-digit number assigned to each drug product considered to be compliant to the Food and Drug Act and its Regulations in Canada. It does not apply to radiopharmaceuticals. A DIN uniquely identifies the product manufacturer, product name, active ingredients, strengths, pharmaceutical form and route of administration. This number is assigned to a drug product, provided to the sponsor along with a Notice of Compliance.

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

SPharm Canada

With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.

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Notice of Compliance with Conditions versus Priority Review

What is the difference between Notice of Compliance with Conditions and Priority Review?

WHAT IS THE DIFFERENCE BETWEEN THE NOTICE OF COMPLIANCE WITH CONDITIONS AND THE PRIORITY REVIEW?

These two processes apply to drugs used to treat conditions that are serious, life-threatening or for a severely debilitating disease (such as Alzheimer’s disease, cancer, AIDS, or Parkinson’s Disease).

Priority Review (PR) applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases, that is, once the clinical development is completed. The total review timeline is reduced from 355 days to 215 days.

On the other hand, the Notice of Compliance with condition (NOC/c) applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. In summary, the NOC/c can be granted with less clinical data than usually expected, that is with Phase II study results or interim reports of Phase III studies. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety. The total review timeline is reduced from 355 days to 235 days.

The condition needs to be agreed to with Health Canada. Some of the conditions of the NOC/c may include a requirement to closely monitor the drug for safety and adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation of “with condition” is removed from the NOC.

To be considered for PR or NOC/c, the drug considered need to meet specific Health Canada criteria, that can be summarized as follows:

Offer effective treatment, prevention or diagnosis of a disease or condition for which no drug is available in Canada; or
Offer an improved benefit/risk profile over existing therapies, preventatives or diagnostic agents for a disease or condition, not adequately managed by a drug marketed in Canada.

Again, discussing with a Canadian regulatory expert in the early drug development stages can be an advantage for early input to establish the ideal regulatory strategy, as well as to help navigate through the requirements that are specific to Canada, while keeping in mind the global market strategy.

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

SPharm Canada

With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.

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Are drug labels to be submitted during the Clinical Trial Application?

DO DRUG PRODUCT LABELS NEED TO BE SUBMITTED DURING THE CLINICAL TRIAL APPLICATION?

No, clinical trial drug product labels do not need to be submitted at the time of the Clinical Trial Application. Labels must conform with section C.05.011 of the Food and Drug Regulations, in both official language, and should be provided to Health Canada upon request.

SPharm Canada

With a quarter of a century of consistent and successful results, SPharm has become one of the leading Drug Regulatory Advisory firms in Canada. Drug companies from around the world count on SPharm to help them navigate the drug (and other health products) review & approval process in Canada.

Avec un quart de siècle de résultats et de succès constants , SPharm est devenue une entreprise de services de référence au Canada en stratégie de développement de médicaments et affaires réglementaires. Des compagnies pharmaceutiques à travers le monde comptent sur SPharm pour faciliter le processus d’homologation de leurs médicaments (et autres produits de santé) au Canada.

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