Medicinal Products development is a long, complex and expensive process. It could take at least 10 years before the product can be marketed.
From Revio, we would like to share with you some of the most optimal regulatory strategies that can maximize the opportunity of your product to achieve your goals.
Start with a team approach
Internally, the initial step to develop a strong regulatory strategy is to gather contributions from the different teams that are involved in the drug development journey: research, manufacturing, quality control, quality assurance, preclinical, clinical, project management, marketing, legal and executive, among others.
In the case of outsourcing key elements of the development program, like regulatory affairs, it is essential to develop and open dialogue and maintain good communication. Also, if the manufacturing, non-clinical and/or clinical research are outsourced, audits should be performed to make sure all Good Manufacturing/Laboratory/Clinical Practices respectively are strictly implemented.
Evaluate attributes and potential liabilities that could have regulatory impact
The stakeholders must quantify the attributes to deeply understand all the regulatory implications of its use, performance and design. In a good regulatory strategy, every stakeholder needs to understand the new drug comprehensively. Some of the attributes to evaluate are:
- Pathology to address.
- Patient populations.
- Target markets.
- Design, mechanism and functionality.
- Competitors: enterprises and products.
- Regulatory and jurisdictional concerns.
Check previous benchmarks and perform regulatory intelligence
It is important to analyse and try to find precedents of other products, with analogues characteristics as your product, that could anticipate any issues. You will find this type of information in the more important regulatory entities websites like EMA or FDA. In the same way, you will get them at a level of clinical investigation products, like ClinicalTrials.gov.
Studying past submissions of other products with analogies will provide insight into past strategies that have either succeeded or failed. This could determine if any issues may come up from a regulatory perspective and what would be the best way to address it.
Take advantage of the resources provided by regulatory authorities
There are many moments when the regulatory authorities can help the development of your product. Taking advantage of that can make the difference between reaching the market or not. For example, if your company is a SME (micro, small or medium-sized enterprises), EMA offers several incentives and benefits. Some of them are assistance on pharmaceutical legislation, fee reductions, workshops and training sessions and guidance on clinical data publications.
Also, sometimes your project can get an accelerated assessment that will help your drug meet the market more quickly, minimizing costs and boosting earnings. If your medicine target and unmet medical need, it would be eligible in the PRIME scheme getting an accelerated assessment among other benefits. In case of orphan medicines, the Agency will offer protocol assistance at a reduced charge, you will be allowed to make a single application for marketing authorization centrally in the EU and will benefit also from ten years of protection from market competitions.
Be always learning and improving
The regulatory environment is always changing, so Regulatory Affairs professionals must be aware of the latest laws and regulations that could impact in the company’s activities.
With ever-evolving laws, regulations and guidelines, a regulatory strategy is a ‘’work in progress’’. The experience is key when talking about regulatory affairs.
This is some of the information you need to know if you are interested in strategies for regulating. Nevertheless, we have launched a dedicated webpage to bring you the latest updates, guidance and developments. You can also follow us on LinkedIn.
We hope you find this useful and of interest. If you would like to discuss any of these updates with the team at REVIO, please get in touch
If you want to know more, check out some official information click HERE!
