A complex and expensive process such as drug development requires a clear and coherent strategy from which a tactical action plan can be developed and implemented.
The regulatory strategy outlines major development milestones and success criteria, facilitates cost and timeline estimates, and provides a basis for sound decisions and project portfolio prioritization and management. This roadmap must be developed as early as possible and is a living document that is revisited regularly. A combination of multi-disciplinary experts is required to include alternative development options or scenarios that help avoid or mitigate risks.
The roadmap provides clear direction to a program’s ultimate destination. It’s a plan that identifies critical paths and issues, mitigates risk, and optimizes the overall time to a New Drug Application (NDA) or Marketing Authorization Application (MAA) filing in a defined regulatory environment.
Our team of experts facilitate and guide clients through the process of formulating the roadmap, provide critical review of one or more elements of the roadmap, or provide hands on operational support through authoring some or all the components.
Elements of strategic planning - Major Regulatory Requirements
The major parts of a comprehensive drug development strategy include the target product profile (TPP), and the regulatory, nonclinical, clinical, manufacturing, and commercial plans. Integrating all these elements together in a seamless strategy document is a critical first step on the road toward realizing a program’s ultimate goals.
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TPP is a critical element of the strategic plan in product development. Including all elements of the expected prescribing information the TPP forms the basis for many elements of the product development but also for discussions with regulators and Health Authorities. Assessment of the market and competition supports the preparation of the TPP. Normally the marketing function will provide this. This may also include elements of HTA where study end points can be mapped to clinical efficacy but also to payer reimbursement criteria.
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Non-clinical plan considers the studies to be planned, timelines, and associated risks and issues. The required data for ongoing stages of clinical studies and ultimately MAA/NDA will be scheduled
- Clinical development program approach is critical to the ultimate indication approved and has consequences in the largest budget allocation during development.
- Regulatory strategy brings all the key disciplines together versus the expected regional requirements and approval pathway(s). Risk Management Plans (RMP) are normally considered early in development.
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Life cycle management, whilst seemingly, a long way away at the point of product development, does influence decision making. For instance, should an additional study be conducted during development to save a burden of testing in post approval?
Non-clinical plan considers the studies to be planned, timelines, and associated risks and issues. The required data for ongoing stages of clinical studies and ultimately MAA/NDA will be scheduled.
Clinical development approach is critical to the ultimate indication approved and has consequences in the largest budget allocation during development.
Regulatory strategy brings all the key disciplines together versus the expected regional requirements and approval pathway(s). Risk Management Plans (RMP) are normally considered early in development.
Life cycle management, whilst seemingly, a long way away at the point of product development, does influence decision making. For instance, should an additional study be conducted during development to save a burden of testing in post approval?
Regulatory Roadmap summary for clinical development program and beyond
Key elements of the planning process are :
- Development strategy
- Target Product Profile
- Non-clinical development strategy
- Clinical development strategy
- Quality and manufacturing strategy
- Overall regulatory strategy
- Market and competition analysis
- Life cycle management strategy and plan
FAQS
How do you create a regulatory strategy?
The regulatory strategy should be created as early as possible in the development process. It is a living document that is revisited regularly. A combination of multi-disciplinary experts is required to include alternative development options or scenarios that help avoid or mitigate risks.
The regulatory strategy outlines major development milestones and success criteria, facilitates cost and timeline estimates, and ensures that everyone involved in the development process is aware of and working toward common goals.
The regulatory strategy should be created by a team of experts that includes representatives from each relevant discipline, including regulatory affairs, clinical research, quality assurance, manufacturing, and marketing.
When creating the regulatory strategy, the team should consider all relevant factors, including the development process, the product’s intended use, the manufacturing process, and the target market. The team should also consider potential risks and issues that could impact the development process or the product’s approval.
After this single document is created, it should be reviewed and updated regularly to ensure that it remains accurate and relevant.
What are the benefits of a regulatory strategy?
A well-developed regulatory strategy can significantly improve the chances of success for a product development program.
A regulatory strategy can help streamline the development process by outlining major milestones, regulatory requirements and success criteria. This can save time and money by preventing the need for duplicate or unnecessary studies during pre and clinical trials as well as ensuring regulatory compliance all along medicinal product lifecycle.
A regulatory strategy can also help ensure that everyone involved in the development process is aware of and working toward common goals. This can improve communication and collaboration among team members.
Finally, a regulatory strategy can help identify potential risks and issues that could impact the development process or the product’s approval. This information can be used to develop mitigation strategies that can reduce the chances of problems occurring.
What are the risks of not having a regulatory strategy?
There are several risks associated with not having a regulatory strategy. These risks include :
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Increased development costs: Without a regulatory strategy, the development process can be longer and more expensive. This is because there is no clear plan for achieving development milestones.
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Increased regulatory risk: Without a regulatory strategy, there is a greater risk that the product will not meet all regulatory requirements. This can delay or prevent approval of the product.
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Decreased marketability: Without a regulatory strategy, the product may be less marketable to potential customers. This is because the product’s development may not have been designed to meet the needs of the target market.
What should be included in a regulatory strategy?
There are several key elements that should be included in a regulatory strategy. These elements include:
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Development strategy: The development strategy should outline the overall goals and objectives of the product development program. It should also describe the planned approach for achieving these goals.
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Target Product Profile: The Target Product Profile should describe the desired characteristics of the product. This information can be used to guide the development process and help ensure that the product meets the needs of the target market.
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Non-clinical development strategy: The non-clinical development strategy should describe the planned approach for conducting non-clinical studies. This information can be used to assess the safety and efficacy of the product.
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Clinical development plan: The clinical development strategy should describe the planned approach for conducting clinical studies. This information can be used to assess the safety and efficacy of the product in humans.
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Quality and manufacturing strategy: The quality and manufacturing strategy should describe the plans for ensuring that the product meets quality standards. This information can be used to assess the safety and efficacy of the product.
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Regulatory affairs strategy: The regulatory affairs strategy should describe the plans for interacting with regulatory agencies. This information can be used to ensure that the product meets all regulatory requirements and increase chance of regulatory approval success.
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Marketing strategy: The marketing strategy should describe the plans for promoting and selling the product in target markets. This information can be used to assess the potential market for the product.
What are the benefits of having a regulatory strategy?
There are several benefits associated with having a regulatory strategy. These benefits include:
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Improved chances of success: A well-developed regulatory strategy can improve the chances of success for a product development program.
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Streamlined development process: A regulatory strategy can help streamline the development process by providing a clear plan for achieving development milestones.
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Decreased development costs: A regulatory strategy can help reduce the overall cost of product development by minimizing the need for rework and maximizing efficiency.
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Improved communication and collaboration: A regulatory strategy can improve communication and collaboration among team members by providing a clear roadmap for the development process.
A regulatory strategy is a critical element of any product development program. It can help streamline the development process, reduce costs, and improve the chances of success for the product.
Without a regulatory strategy, there is a greater risk that the product will not meet all regulatory requirements, which can delay or prevent approval of the product. Additionally, the product may be less marketable to potential customers without a regulatory strategy in place. Therefore, it is important to develop a regulatory strategy early on in the product development process.
Example of potential regulatory issues: Regulatory Challenges during clinical trials in Europe
There are a number of regulatory challenges that can arise during clinical trials in Europe. These challenges include :
1. Ensuring compliance with the clinical trial directive
The clinical trial directive is a set of regulations that govern clinical trials in Europe. Sponsors of clinical trials must ensure that their trials comply with these regulations.
2. Obtaining ethical approval
All clinical trials must be approved by an ethics committee before they can commence. This approval must be obtained from the country in which the trial is taking place.
3. Complying with data protection requirements
Clinical trials generate a large amount of personal data. Sponsors of clinical trials must ensure that this data is protected in accordance with European data protection law.
4. Managing cross-border clinical trials
Clinical trials often involve more than one country. Sponsors of cross-border clinical trials must ensure that they comply with the different regulations in each country.
5. Ensuring patient safety
Patient safety is of paramount importance in clinical trials. Sponsors of clinical trials must put in place measures to protect patients from risks associated with the trial.
6. Managing trial sponsors
Trial sponsors are responsible for the conduct of the trial. Sponsors of clinical trials must ensure that they have adequate systems and processes in place to manage trial sponsors.
7. Minimizing delays in trial start-up
Delays in the start-up of clinical trials can lead to significant cost and time overruns. Sponsors of clinical trials must take steps to minimise these delays.
8. Addressing issues with clinical trial applications
Clinical trial applications can be rejected for a number of reasons. Sponsors of clinical trials must address any issues with their applications before resubmitting them.
9. Maintaining quality control during the trial
It is important to maintain a high level of quality control during clinical trials. Sponsors of clinical trials must put in place measures to ensure that the trial is conducted in accordance with good clinical practice.
10. Avoiding breaches of good clinical practice
Breaches of good clinical practice can lead to serious consequences for sponsors of clinical trials. Sponsors of clinical trials must take steps to avoid these breaches.
11. Dealing with protocol amendments
Protocol amendments are changes to the trial protocol that are made after the trial has commenced. Sponsors of clinical trials must ensure that they deal with these amendments in a timely and efficient manner.
12. Ensuring timely data reporting
The timely reporting of clinical trial data is essential for the success of the trial. Sponsors of clinical trials must ensure that they have systems and processes in place to ensure that data is reported in a timely manner.
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