Does Health Canada prefer early phase or late phase trials?

Does Health Canada prefer early phase trials or late phase studies close to approval?

DOES HEALTH CANADA PREFER EARLY PHASE TRIAL DESIGNS OR LATE PHASE STUDIES CLOSE TO APPROVAL?

Health Canada is very open to all phases of clinical trials for both early and late phase. If the product is innovative or has the potential of being granted an NOC/c, we do recommend that sponsors meet with Health Canada early to ensure that the study trial design and the clinical development plan is aligned with the requirements for an accelerated access to market.

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.

Why does Health Canada ask for Foreign Reviews?

WHY IS IT THAT HEALTH CANADA ASKS FOR FOREIGN REVIEWS?

The provision of foreign review reports in an NDS is not mandatory, but highly recommended. Indeed, they are usually requested at screening if not included within the original submission.

In addition, within the Screening Acceptance letter, Health Canada usually requests the sponsor to share the Questions from foreign regulatory agency reviews and the sponsor’s answers, during the review of the NDS.

In my experience and through my discussions with Health Canada, when the Canadian agency has questions that have already been addressed in a response to questions from a foreign agency, it likely reduces the number of questions to be raised to the sponsor, accordingly.

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

What type of Market Protection exists for new Drugs in Canada?

WHAT TYPE OF MARKET PROTECTION IS APPLICABLE IN CANADA AND HOW DOES IT APPLY?

All drug products containing a new chemical entity are eligible to an eight-year period of market exclusivity. Should the drug product be aimed for a pediatric population, a further six-month extension can apply if the acceptable pediatric data are submitted within the first 5 years of the 8-year period. Health Canada will conduct a preliminary assessment while the drug is under review (NDS) and the sponsor will be notified of the outcome.

Consequently, a subsequent-entry manufacturer is not allowed to file a submission for a generic drug for the first six years of the eight-year period. For products with eligible patents, submission of patent forms within the planned NDS and SNDS is critical to avoid loss of rights and generic entries to the market earlier than the market allows.

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada

How long does it take a life science product to be approved in Canada?

WHAT ARE HEALTH CANADA’S TIMELINES TO PROVIDE AUTHORIZATION FOR A DRUG TO BE SOLD ON THE CANADIAN MARKET?

The Canadian review timeline for a New Drug Submission (NDS) is competitive. A standard review consists of a maximum of 10 days eCTD validation, followed by 45 days administrative screening where it is verified that the content is acceptable and that no key information is missing. Following the screening period, a 300-day scientific review of the quality, non-clinical and clinical data packages, applies. Therefore, a total of 355 review days applies, before a sponsor obtains a final review decision.

Should the NDS qualify for an accelerated review either under a Priority Review or a Notice of Compliance with condition, the review timelines are shorter.

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.

canadian drug approval process clinical trial application canada clinical trial approval canada drug approval consultant canada drug approval consultants canada drug approval process in canada Drug Life cycle Management drug regulatory consultant canada drug regulatory experts canada drug regulatory process canada drug review canada eCTD Canada eCTD Publishing Services health canada drug approval How Drugs are reviewed in Canada New Drug Submission Notice of Compliance pharmacovigilance pharmacovigilance canada