Companies in the food, supplements, drug, personal care, medical devices and cosmetics industries are under more pressure than ever to stay compliant with the changing and ever-increasing regulations, and at the same time to remain competitive in the global marketplace. Challenges are seen across different aspects of business, from developing new products to seeking regulators’ approvals and implementing a pathway to market access, there are increased burdens and costs for companies to operate successfully in every step of their business.
As international and local regulations increase in both volume and stringency, marketing food, drugs, supplements, personal care products, cosmetics or medical devices in new territories requires a well-structured 监管策略 that enables companies to navigate the complexities and achieve commercial success.
在 RegASK, we work with local experts across 140 countries to help companies develop and implement forward-looking regulatory strategies for market entry and product development. Based on our rich experience working with a wide range of companies including some of the world’s largest food and drug makers, we understand what it takes to be successful in business expansion, and would like to share in this article the knowledge and best practices on regulatory strategies to help companies meet regulatory compliance requirements and maintain a competitive edge in their target markets.
- What is a regulatory strategy and why do you need one?
- What does a successful regulatory strategy look like?
- How to build a winning regulatory strategy for your business?
- Implementing a regulatory strategy: overcoming common challenges
- Get started with your regulatory strategy: how RegASK can help
- Regulatory strategy conclusion
What is a 监管策略 and why do you need one?
A regulatory strategy is a set of policies, procedures, plan or actions that help a business bring a product to market by identifying and addressing the legal, compliance, and risk management needs. The ultimate objective of a company’s regulatory strategy is to enable business success while ensuring regulatory compliance.
The core elements of a company’s regulatory strategy are:
– Goals, objectives and success metrics: A clear understanding of what you want to achieve with your regulatory strategy and how to measure the results.
– Interpretation of the regulatory landscape: The regulations and interpretative guidelines which apply to your business.
– Compliance program: A way to ensure that you are in compliance with all applicable regulations.
– Potential risks and hurdles: An assessment of the regulatory risks your business is exposed to.
– Business and regulatory impact and likely outcomes: The impact on business operations if there is non-compliance to any regulation.
It is important for a company to have a regulatory strategy in place. Here are four benefits of having a regulatory strategy in your company:
- It helps the company understand and comply with all applicable laws, regulations, and guidelines so that compliance will be achieved and maintained for all products.
- It helps the company maintain a competitive edge in its market. A regulatory strategy provides direction on R&D, clinical trial design, innovation, product development, portfolio expansion, and market pathway, helping the company prioritize its resources and budget to achieve its objectives.
- A regulatory strategy provides a solid understanding of what is required to be successful in the business and serves as action guidance on meeting the objectives. For example, it helps define the timelines, milestones, risks, and reactions to potential hurdles, providing a clear set of actions to the regulatory affairs team and other stakeholders involved.
- A regulatory strategy helps the company enhance customer satisfaction and brand value by proactively responding to the ever-changing market demand.
Regulations are not just a cost factor, but they also create opportunities for businesses to innovate and grow their market share. From obtaining market entry permission to winning customers’ trust, a regulatory strategy helps differentiate your business from competitors.
What does a successful regulatory strategy look like?
To define a successful regulatory strategy, one must first define their business goals and then take into consideration the regulatory objectives. Once these objectives are determined, it is important to find a balance between compliance and profit maximization. A successful regulatory strategy is one that is aligned with business goals, regulatory objectives and compliance.
The main characteristics of a successful regulatory strategy include:
- Comprehensive: A successful regulatory strategy needs to be comprehensive and should not be limited to just one or two aspects of the business. It should consider all stages of a product lifecycle including clinical studies, product development, submission for approval, product 标签, marketing and promotion and regulatory intelligence. It also needs to be designed with all potential stakeholders in mind.
- Responsive: The strategy should provide strategic advice or guideline to address all potential 监管变化, including those not yet known or anticipated. This can help the company anticipate future opportunities or threats. For example, if there are new markets on the horizon, then it is important for the company to have a plan in place to create a predictable product development roadmap to enter those markets before losing out on an opportunity.
- Adaptive and proactive: A regulatory strategy must be able to adapt to changes in the environment and be able to change goals as needed. It’s also a forward-looking strategy that considers all possible scenarios, highlights potential product development issues, and proactively recommends measures to reduce the risk of being caught off guard by new regulations in the future.
- Tailored and contextualized: A regulatory strategy needs to be tailored to the company’s specific situation and needs and aligned with both short-term and long-term business objectives.
- Actionable: a regulatory should also outline specific steps and actions that can be taken to help the company navigate the journey and meet the regulatory strategy objectives.
How to build a winning regulatory strategy for your business?
A regulatory strategy is a set of policies, procedures and actions that are put in place to ensure compliance with the regulations and guidance while also maximizing competitiveness. This section explores how you can develop a winning strategy for your business. It starts by looking at what steps need to be taken to create a regulatory strategy and then goes on to explore how to implement it for your business.
1. Identifying your target markets
To start off, it is important to identify your target markets and understand what customer requirements are and how your product can fit those needs. You also need to think about what your company’s strengths are and what opportunities exist for you in the market. The opportunity can arise from the emergence of a new regulation or a regulatory change, therefore it’s essential to actively monitor regulatory changes for better foresight.
2. Defining product functions and features
The next thing you will want to do is to determine the features, functions, and attributes of your product that will attract customers to buy from you.
3. Identifying regulatory requirements
Regulatory requirements can be federal, state, or local, and specifically cover trade, health & safety, food
production & services, labeling & packaging, drug administration, regulatory submission, preclinical and clinical studies, regulatory pathway and more. Knowing which regulations and guidance documents apply to your target markets and what are the future regulatory developments is key for success. For example, if you are marketing toward children in the United States then your product needs to meet the Food and Drug Administration (FDA) requirements with special consideration for safety and hazards related regulations. Partner with RegASK on industry analysis and regulatory strategy to have a better understanding of what your needs are and prepare accordingly.
4. Conducting an impact analysis
An impact analysis is a type of study that assesses the magnitude, timing and distribution of the benefits and costs for each possible course of action. These analyses are often conducted in order to make decisions about where to allocate resources within an organization or to identify the best path for a product. A rigorous assessment of the short and long-term impact at each step of implementation based on different scenarios is critical to strategic planning and prioritizing a company’s efforts.
5. Setting objectives, deliverables, timelines, milestones and responsibilities
Planning a regulatory strategy requires a lot of time, research and thoughts. Without proper planning, tactical decisions may not be made in the best interest of the business. For example, a business may have the goal of launching a new drug in one year but discover that additional clinical trials are required and the clearance process takes longer than expected. The timeline quickly becomes unrealistic. In addition, each department involved in the regulatory strategy should clearly understand their responsibilities and KPIs.
6. Establishing policies and procedures
It is imperative that companies establish policies and procedures for various scenarios in order to minimize the risk of a catastrophic event. Larger companies with a global footprint are at the forefront of establishing written policies and procedures to address potential regulatory issues rising from different legal regimes and jurisdictions. This includes developing a solid risk management program, identifying risks and hazards of the product and assigning them to appropriate controls.
7. Reviewing the regulatory strategy with stakeholders
A regulatory strategy should be reviewed by a group of people in your organization who are knowledgeable about the company’s operations. The team should include the CEO, General Counsel, Chief Compliance Officer, Chief Risk Officer, Chief Financial Officer, departments of R&D, quality, clinical operations, marketing, regulatory affairs and other key stakeholders. This ensures that the strategy reflects business goals and is an integral part of the company’s market growth strategies.
8. Updating the strategy periodically
The regulatory strategy should be updated periodically to reflect changes in the business or regulatory environment. “Post-market safety data monitoring now is a universal regulatory authority requirement for marketing approval,” analyzing post-market surveillance data can help identify the safety issues and make better decisions[1].
A regulatory strategy can be implemented as part of an overall business strategy or as a stand-alone strategy. Similar to implementing other types of strategies, there are 3 key pillars for successfully executing a regulatory strategy within a company:
- Motivation
- Communication and collaboration
- Capabilities
When executing a strategy, challenges can arise from internal and external factors that could hinder the execution. In the next section, we will discuss the common challenges that companies are facing and how to address them in order to successfully implement a regulatory strategy.
Contact RegASK to get free consultation on your regulatory strategy
Implementing a regulatory strategy: overcoming common challenges
There are five common challenges or barriers that may prevent organizations from executing their regulatory strategies:
- Inconsistency across jurisdictions
Ideally, a regulatory strategy should be developed in such a way that it can be applied across all the business units, products, services, and geographies of your company. In reality, however, a global regulatory strategy can be difficult to be applied in a particular country due to the unique regulatory environment, cultures, languages and norms. In this case, a global regulatory strategy needs to be adjusted and tailored to local situations, a country-specific regulatory strategy can be considered.
- Conflicting priorities
When a product is launched in multiple countries with multiline submissions and marketing promotions, it can be difficult to prioritize one country over another, or the original prioritization may generate conflicting results. For example, the U.S. FDA[2] and European Medicines Agency (EMA)[3] allow flexible and expedited review processes for new drugs[4]. Hence the regulatory strategy needs to have a certain level of flexibility and agility to allow adjustment of priorities based on real data, intelligence and results[5].
Here are three tips for resolving the conflict: the first step is to create a list of what can be done with reduced effort, i.e., prioritizing markets with easy entry and fast returns to meet financial goals. Next, determine which tasks can be done in parallel. Finally, determine priorities based on the timeline and urgency.
- Lack of engagement
A regulatory strategy cannot be implemented in isolation from other business areas. Collaboration with key stakeholders is necessary for a strategy’s success. They need to buy in for the best results. The regulatory affairs team who are usually responsible for executing the regulatory strategy must proactively engage with multiple stakeholders, understand their agendas and priorities, get them involved in the decision-making process, empower them to make an impact, and make sure they are properly rewarded. These practices and processes help create a multidisciplinary team to support the regulatory strategy.
- Lack of capacities
Many SMEs lack the capacity to implement a strategy due to limited funding, time, or knowledge. Capacity building is a critical step to helping organizations develop and cultivate their social, technological, and financial resources, and recruit the right talents to enable the deliverables. SMEs may consider engaging an external regulatory consultant who is able to provide assistance with developing and implementing the strategy.
- Regulatory changes
Regulations are constantly evolving, in order to stay ahead of the curve, you need to be aware of the changes that are coming. Many companies have adopted AI-powered 监管监控 tools to predict regulatory changes and developments to gain better foresight. It is also important not to wait too long before adjusting your regulatory strategy as compliance risks increase when they are not managed in a timely manner. RegASK’s 监管洞察 tool detects early signals of potential regulatory changes and key market trends to drive your business strategies and lower your business risks.
- Scrutiny by regulatory agencies
Regulatory agencies are a part of the regulatory environment in which companies operate. They review product submissions and have the power to deny a company’s products or services. Getting regulatory approval can be a lengthy and strenuous process. It is essential for companies to establish a professional and courteous relationship with regulatory agencies from the beginning, by respecting their processes and engaging in continuous dialogue with them to streamline the approval process. A primary key to success is the early engagement of regulatory agencies[6].
RegASK works collaboratively with regulatory agencies across 140 countries and helps companies set up and implement end-to-end regulatory strategies that regulators expect to see. Here are our practical tips to help companies make the process smoother:
- Engage regulatory agency officials at an early stage to understand their requirements or obtain advice.
- Be familiar with the scope of regulations and applicable guidance documents, closely follow the guidelines and meet requirements.
- Prepare sufficient but concise information in one or separate documents with a clear structure for easy reviewing and navigation.
- Interact with regulatory agencies through emails, meetings or phone calls to present your regulatory strategy with a detailed action plan, and clearly articulate how you will execute it and overcome challenges.
Get started with your regulatory strategy: how RegASK can help
RegASK is a RegTech company leveraging artificial intelligence and decades of consultancy experience to help companies succeed in their international market entry plans. Our regulatory strategy team is passionate about helping clients navigate the regulatory challenges they face. We use our experience to quickly identify the best course of action and create tailored regulatory strategies to help you maximize commercial value.
Our approach
We help you create strategies for market entry and product development to achieve commercial success:
- Prepare and submit regulatory dossiers
- Monitor registration deadlines and renewal submissions
- Communicate with regulatory agencies to demonstrate your regulatory strategy and ensure approval
- 标签和配方合规性
- Path-to-market assessment
- Marketing and advertising materials compliance
We re-evaluate your regulatory strategy on a regular basis, especially when you expand into new product categories and markets:
- Identify and mitigate the risks associated with category expansion
- Unlock growth opportunities using gap and match analysis
- Analyze competitors and determine your competitive edge
- Assess new markets and develop a route-to-market plan
We detect and interpret regulatory changes for you using our AI-powered intelligence monitoring platform and 400+ local regulatory experts network:
- Alert you on any regulatory changes anywhere in the world
- Interpret regulatory changes and how they impact your business
- Advise on how to address a potential lapse in product compliance
Industries we serve
- Food and Beverage
- 个人护理和化妆品
- 动物护理
- 制药和生物技术
- 医疗设备
- 家庭和工业护理
Regulatory strategy conclusion
There is a growing need for regulatory affairs professionals to think beyond regulatory compliance. They need to be scientific and strategic in their approach[7], and manage emerging policy issues in alignment with business objectives. Collaborations with internal and external stakeholders is the key to success.
We provide you with a one-stop shop to manage all your regulatory needs. From creating a regulatory pathway to managing complex relationships with authorities and product rollout, we do it all.
Markets are changing all the time. Be proactive and take charge of your business environment by understanding what you need to do, who you need to do it with and when you need it done. With our in-depth industry knowledge and expertise, we can quickly understand your business environment, identify the opportunities and risks involved, and work on solutions that are customized just for you. Don’t wait until the opportunities are gone, 联系我们 today to find out the best regulatory strategy for your business.
参考：
[1] U.S. FDA – Frequently Asked Questions: Breakthrough Therapies
[2] European Medicines Agency – Accelerated assessment
[3] Nagai, Sumimasa. 2019. “Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan” International Journal of Molecular Sciences 20, no. 15: 3801. https://doi.org/10.3390/ijms20153801
[4] The Association of Clinical Research Professionals (ACRP) – Expediting Drug Development Regulatory Pathways Globally
[5] The Association of Clinical Research Professionals (ACRP) – Expediting Drug Development Regulatory Pathways Globally
[6] Global Pharmaceutical and Biologics Regulatory Strategy, Second Edition, Chapter 15, By Chris Walker and Tina Soulis
[7] How Preparing a Drug for FDA Approval Requires the Mind of a Scientist and Strategist