What adjustments are made for Targeted Therapeutics?

What adjustments do drug developers make associated to Targeted Therapeutics?

WHAT ADJUSTMENTS HAVE DRUG DEVELOPERS HAD TO MAKE TO RESPOND TO CHALLENGES ASSOCIATED WITH TARGETED THERAPEUTICS?

The key adjustments for drug developers have been to increase transparency with the authorities and open up to pre-submission or scientific advice meetings. These meetings become even more efficient when you bring in local experts and key opinion leaders.

The purpose of this is to discuss strategies and requirements with the authorities and to come up with agreements for the drug development activities. Meeting with Health Canada is not a requirement, but it’s highly recommended for novel therapies that would not have the same clinical data package that would usually be required or expected in Canada for market access.

With regards to submission content, contrary to common belief, Health Canada follows similar requirements to those of the FDA and EMA, therefore, usually only minor adjustments are necessary from a FDA or EMA dossier when submitting a marketing application in Canada.

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.

Will Health Canada approve Trials with multiple investigational products?

Will Health Canada approve Clinical Trials designed with more than one investigational product?

WILL HEALTH CANADA APPROVE CLINICAL TRIALS DESIGNED WITH MORE THAN ONE INVESTIGATIONAL PRODUCT?

Yes, definitely. With the appropriate quality information for both investigational products, Health Canada will review the dossier and approve it if it meets the Canadian requirements, and that will be under the same 30-day default review period.

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 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.

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

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

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