How to Determine your Regulatory Affairs Needs

DETERMINING YOUR DRUG REGULATORY AFFAIRS NEEDS

Well-defined and appropriately supported regulatory needs increase the likelihood of successful submissions and market access. So how does one go about determining what those regulatory needs are or might be, especially when embarking in a health product development process at its initial stages?

Also, are there different considerations for pharma, biotech, and investigator led trials?

The short answer is yes.

It takes experience to establish a good health product development strategy and to build trust and communication channels that clearly communicate its details. Get it right, and you can reduce possible errors, save time and money, and lessen the steep learning curves that are common at the start of a mandate.

Together we will look more closely at the considerations for starting to define needs as a whole whether you are Pharma, Biotech or an Academic institution. Let’s look at the unique needs for each:

 

REGULATORY AFFAIRS FOR PHARMA

As a pharma, you have regulatory professionals on board. In instances when in-house staff does not have the expertise required in a specific situation, you will need to hire for a specific need, an expert to work in collaboration with your team. (i.e. orphan drugs, oncology, products that can be considered for priority reviews or NOC with condition, literature-based dossiers, etc.). In instances when workload is very high, or during peaks of activity, external professionals will act as an extension of your team and alleviate congestion, avoid delays and ensure timelines are respected.

 

REGULATORY AFFAIRS FOR BIOTECH

For a biotech, particularly start-ups, it is unlikely to have a regulatory expert on staff. Development is costlier with biology / biotech products which means that cost efficient health product development is key.  Considering the greater health product development costs for biotechnology companies, the impact of failures and errors is more significant.  As a biotech, one of the most significant impact that a regulatory professional’s expertise and regulatory intelligence will have is in streamlining the regulatory process. They will increase efficiency to save you time and money.

 

INVESTIGATOR DRIVEN CLINICAL TRIALS

It isn’t uncommon for investigator driven clinical trials to commence without at least an initial consultation with regulatory agencies. This typically happens when the investigators are unfamiliar with the characteristics and requirements of the regulatory process or don’t consider that the obligations apply equally to investigators as they do pharma and biotech start-ups. For some others, it’s seen as a viable cost-cutting measure until they see once in the trial that, had they had a regulatory professional to draw on in the planning stages, it would save more time, cost less money, and increase efficacy. The obligations are the same whether the sponsor is a manufacture or an investigator and it’s important that the clinical trial initiatives are developed in line with regulatory obligations and Good Clinical Practices (GCPs).  A regulatory affairs professional will be able to ensure the study starts off in observance of the applicable regulations and GCPs.

Also, all studies conducted with a health product have the potential to be included in a registration dossier, making having a regulatory professional involved from the moment you begin to think about planning a study is a significant advantage. An expert who can help plan the health product development efficiently, including clinical development, such that no investment is lost via suboptimal planning is particularly important.

 

HIRE REGULATORY EXPERTS EARLY

Whether you are a sponsor in pharma, a biotech, or an investigator, you will need regulatory support from inception to submission, and a good way to begin a needs assessment is with questions at the research planning stages that shape the thinking process; there are three in particular that are wise to consider at the start.

Best practices assert that the earlier a regulatory expert is brought on, the better the outcomes. A way to look at this is, bringing in a regulatory professional on for the first time at the submission stage, would be akin to hiring a boat maker after you’ve already built a boat and want help to put it in the water.

Hiring at the start to define needs and formulate a strategic regulatory plan produces three significant advantages:  

  1. Ensure the research is relevant and that it will address a medical need / allow for market access so that funds are not misspent.
  2. Establish a smooth relationship with Health Canada teams built on the positive reputation of the regulatory professional.
  3. Accelerate Health Canada’s confidence in the company developing the product because the person interfacing speaks the same language as the regulatory agency.

Deciding whether to hire for the entire process, or part of it.

Needs change and issues can arise because both the product development and regulatory landscape evolve. New laws and regulations, requirements, and even innovations have the potential to affect health product development strategies. Regulatory professionals understand this and work it into their strategic plan, making it possible to anticipate changes and overcome challenges should they arise.  The importance of being responsive to these events means that needing to find, hire and transfer knowledge (and all that this entails) would be wasteful of all resources as compared to having a team or dedicated professional involved (and informed) from the start.

Is it possible to use different professionals for different parts of the process?

Throughout every study there is a need for different skill sets and experience. A team (it can be a small one with proven experience) comprised of professionals with deep knowledge of specializations within the health product development and lifecycle management, not only will enable time to not be lost on learning about the project, but also consistency will be maintained in communications with regulatory authorities.

Still, if you opt to go the route of trying out different professionals for different parts of the process, keep in mind the importance of using a polyvalent expert to optimize information and reduce the time and money investment. It speaks directly to the costs associated to the project(s) learning phases. Subject matter expertise is a driving force in how well the development process unfolds because specialists are able to help you avoid and overcome concerns, changes, challenges or other issues along the way. Their work can help reduce overall cost, alleviate workload, and improve timelines.

To ensure that you’ve hired an excellent professional or firm, please read our post on the subject.

The more consistent the team, the lesser mistakes and errors are encountered. Adherence to regulatory requirements are best achieved with the guidance and support of a regulatory affairs professional. This has many benefits, including increasing the worth of the clinical study or development strategy by respecting regulatory paths, for future inclusion of studies/science in a registration dossier.

 

THE TAKEAWAY

Hire a professional early – very early, in fact, at the planning stage so that your needs can be delineated by an experienced professional who can established a plan that will allow the drug development strategy to be responsive to changes. Regulatory needs may change depending on whether you’re in pharma, biotech, or an independent investigator, consult with a regulatory expert before you begin to ensure that nothing is missing within your health product development strategy and / or your study design, in other words, you will want to make sure that your plans will build a boat that floats.

Drug Review & Approval Process in Canada – An Infographic

THE DRUG REVIEW & APPROVAL PROCESS IN CANADA
AN INFOGRAPHIC

What follows is a graphical representation, an Infographic, of the eGuide we published titled “The Drug Review Approval Process in Canada – An eGuide“

DOWNLOAD JPEG VERSION HERE
DOWNLOAD PDF VERSION HERE

Drug Review and Approval Process in Canada

For further information about the drug review & approval process in Canada, please visit our FAQ section or contact SPharm directly.

Myths of clinical trial and drug approval process in Canada

 

Myths of clinical trial and drug approval process in Canada

 

Canada has become an increasingly popular destination for clinical trials and drug approvals. Despite that, misconceptions persist about everything from approval time to the language used in the approval process. We have identified six of the more common myths about clinical trial applications and drug approval in Canada. Which ones have you believed?

Myth # 1: Obtaining approval for clinical trials takes more time in Canada than elsewhere.

Reality: You’ll receive your approval (No Objection Letter) — or rejection — in 30 days. Once a Clinical Trial Application (CTA) has been submitted, questions can be raised by Health Canada to which an answer (with or without commitment) needs to be provided within 2 days. Once the CTA review is complete, Health Canada notifies the sponsor if the application is found to be acceptable or not. If the CTA is acceptable, Health Canada issues a No Objection Letter (NOL) within the standard 30-day review period; this NOL needs to be received before moving forward with the trial and will be needed for investigational drug importation purpose.

Compare that to the U.S., where the FDA has 30 days to determine whether a clinical hold is necessary or if the clinical trial can start. There is no specific duration for a clinical hold in the U.S..  There is no such hold in Canada.

In most european countries in Europe the target review timeline is 60 days but it often takes more than that to obtain a decision at the national level. EMA is looking into applying  a centralized procedure that will have a longer review period than 60 days.

Myth #2: The requirements for a Clinical Trial Application in Canada are more onerous than elsewhere.

Reality: The content requirements are actually less onerous than in the U.S.  and in the EU. No non-clinical or clinical study reports are required to be submitted within the CTA in Canada. What is needed are the administrative documents plus key scientific documents on which Health Canada bases their review on: the protocol, the informed consent form and the investigator’s brochure, in addition to the standard chemistry and manufacturing data. The Clinical Trial Application is composed of three modules:

  • Module 1 – contains administrative and clinical information about the proposed trial
  • Module 2 – contains quality (chemistry and manufacturing) information about the drug
  • Module 3 – contains additional supporting quality information, when needed.

There can be delays in initiating Clinical Trials in Canada, as in other jurisdictions. For instance, there may be delays in obtaining Research Ethics Board reviews and approvals (a decision independent from Health Canada). Also, sponsors and CROs in North America can prioritize the U.S. sites ahead of Canadian sites for many reasons including patient population (see myth no. 3). Typically, for global studies it can take a few months to get a site up and running in Canada.

It is to note that there are efficient clinical trials start-up experts in Canada that helps with streamlining the study start-up processes in parallel or after the clinical trials application approval.

Myth #3: Because of its population size, recruitment and enrollment are difficult in Canada.

Reality: Enrollment — recruitment and retention — is no more of a challenge in Canada than elsewhere. In fact, the average time from trial set up to first patient visit is three months, with 98 percent of subjects enrolled within the planned study period, according to the Canadian Clinical Trials Coordinating Centre (CCTCC).  One reason for this success is that Canada’s universal healthcare system means coordinated access to patients and better patient data.

Moreover, Canadians are highly educated and interested in research:  More than 70 percent of the population has expressed interest in participating in clinical research, according to the CCTCC.

Finally, as one of the most diverse nations in the world, Canada provides researchers to a broad pool of potential subjects.

Myth #4: All study documents must be provided in English and French.

Reality: Either language is accepted; for regulatory submissions, English is used more often. There are two exceptions: Labels and informed consent forms must be in both languages. Of course, all patient materials for trials in Quebec must be translated into French.

Myth #5: Health Canada’s process for approving new drugs is excessively slow.

Reality: Health Canada have established submission review targets that are respected. Submissions to Health Canada are often delayed, but it has very little to do with the Health Canada process.

Research published in the Canadian Medical Association Journal in 2015, found that the submission of new drugs to Health Canada for approval is systematically delayed compared with submissions to regulatory agencies in the United States and the European Union. Over the years, it has been my experience also. Differences across jurisdictions in approval-processing times play a small role in the delays; differences in the timing of drug submissions are clearly an important factor.

Accessibility to new drugs in Canada is delayed primarily because of delays in submission to Health Canada by pharmaceutical companies and not because of a longer nor more complex approval-processing time at Health Canada.

Myth #6: Drug trials costs more in Canada.

Reality: Canada has the second lowest cost among G7 nations in the management, design and coordination of clinical trials. Only France is cheaper, according to the Canadian Clinical Trials Coordinating Centre. Canada has one of the most attractive tax environments for research and development compared to the U.S. and other G7 countries.

Myth #6.5: The Clinical Trial sponsor needs a Canadian presence.

Reality: The CTA must be signed by a scientific or medical officer residing in Canada. Generally, the regulatory agent or the CRO can sign on behalf of the sponsor.

 

The importance of working with Canadian Regulatory Consultants

The Importance of working with Canadian regulatory experts.

 

WHY IS IT IMPORTANT TO WORK WITH EXPERTS IN CANADIAN REGULATORY AFFAIRS?

Having a Canadian regulatory expert is important to facilitate the global Canadian submission process and all post-approval activities. It’s also important to know that Health Canada prefers speaking with individuals that understand the Canadian medical as well as regulatory environment, whether they are the sponsors or their representatives. The support of a Canadian regulatory consultant is key for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. But it is most important for the global product development strategy, particularly when dealing with niche products used for treating orphan or life-threatening diseases. By understanding Canadian as well as foreign regulatory environments, a Canadian consultant can provide the best strategic initiative for timely access to the Canadian market, keeping the global regulatory initiatives in mind.

The regulatory paths for market access in Canada are essentially threefold. First there is the standard regulatory new drug submission path, then there is the notice of compliance with conditions (NOC/c) path, usually applicable for oncology or other niche products, and finally there is the priority review path. The latest two have shorter review standards at Health 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.