Regulatory roadmap – consulting on the selection of the type of application and development plan for registration of the medicinal products
Drug Registration Without Excessive Costs – Regulatory Roadmap to Marketing Authorization
The pharmaceutical world operates within a highly regulated framework, and at first glance, the pathway to obtaining marketing authorization for a new medicinal product may appear straightforward. However, this is not always the case.
Have you developed a novel drug candidate, a new application, or a pharmaceutical form for an existing therapeutic molecule? Are you wondering whether you must always register it as an innovative medicinal product, along with all the extensive, time-consuming, and costly pharmaceutical, non-clinical, and clinical studies that accompany such an application? Or perhaps there are alternative pathways? A well-suited strategy is key to a successful registration process.
Identifying and implementing the proper regulatory roadmap is essential for a successful product registration. Our consulting team specialises in tailoring regulatory approaches that align with your product’s unique characteristics and development goals, ensuring a streamlined and efficient authorisation process.
Regulatory behind marketing authorisation – what types of application could apply to your product
Understanding the European Regulatory Framework
The European regulatory background for medicinal products for human use is laid down in the Directive 2001/83/EC and further explained in Notice to Applicants and regulatory guidelines for medicinal products for human use vol. 2 A. It is important to note that legislative revisions to this Directive are currently underway, which may introduce significant changes.
Despite the structured nature of the framework, not all aspects are rigidly defined. The successful preparation of a marketing authorisation dossier requires not only regulatory knowledge but also a nuanced understanding of how to interpret and apply existing guidelines effectively.
Smart Choices Start Early: Identifying the Optimal Application Type
Whether your drug candidate is a small molecule, a newly established compound or well-known product, or a combination thereof – or if it involves more complex modalities such as biologicals, nanomedicines, or advanced therapy medicinal products (ATMPs) – a thorough assessment of the available application types is essential. Identifying the most suitable and advantageous regulatory pathway from the outset is critical for optimizing your product’s development strategy and accelerating its path to market.
In this analysis, every single detail is important:
- The pharmaceutical form you select,
- The composition of excipients,
- The container closure system,
- The market in which you plan to register your product.
Each of these factors can influence on the type and scope of:
- Quality studies,
- Non-clinical studies,
- Clinical studies required.
Beyond the Studies: Additional Regulatory Activities to Consider
In addition to the studies themselves, there are also other activities which may be required at different stages of registration procedure, including:
- Obtaining a GMP certificate for the manufacturing site(s),
- Ensuring GLP/GCP compliance of the studies,
- Necessity of involvement of a Notified Body (if the medicinal product is accompanied by a medical device),
- Selection of countries to be involved in the procedure
- Addressing additional regulatory requirements if the product is intended for use in the pediatric population*
*In this case you may be required to consult with the EMA and agree on the Paediatric Investigational Plan (PIP) prior to starting the registration procedure.
Optimising Development Strategy for Marketing Authorisation
Generally, three key aspects should be considered when planning the development:
- What types of marketing authorisation applications are suitable for your product from a formal perspective?
- What are the benefits and drawbacks of each application type?
- What is the scope of the studies required for each type of application, including their associated costs and timelines. Are there possibilities to waive certain studies, or is a comprehensive development program, including extensive and resource-intensive clinical studies, necessary?
Our experts are here to assist you in analysing the points outlined above and propose an optimal development plan for your product. We can support you throughout the entire development and beyond, including tasks such as:
- Project management,
- Identifying suitable subcontractors for the manufacturing (if needed),
- Identifying appropriate subcontractors for studies,
- Ensuring the quality of developmental data,
- Preparing the registration dossier,
- submission of the dossier and representing you throughout the process of obtaining the market authorisation.
We do also offer the post-registration services for our clients.
End-to-End Expertise in Drug Registration and Regulatory Compliance
SciencePharma has extensive experience in preparing registration dossiers and managing registration procedures for a wide range of drugs and pharmaceutical forms. Our expertise spans small molecules, biologicals, biosimilars, and ATMPs, across various countries and all types of registration procedures. Additionally, we support our clients during GMP/GCP/GLP inspection/certification or during collaboration with Notified Bodies.
We also provide comprehensive support in preparing detailed plans for the required non-clinical and clinical studies. Our services include recommending suitable CROs and laboratories, managing the studies, and ensuring that the study documentation complies with all relevant regulatory requirements.
20 Years of Regulatory Expertise at Your Service
At SciencePharma, we have 20 years of experience in registering medicinal products in Europe. Our multidisciplinary team provides comprehensive services, starting with analysing your needs, recommending the most suitable regulatory path, and defending it if challenged by the Regulatory Authorities. We offer tailored solutions designed specifically for your project. Every project and product is unique, and so are our solutions.
Your Partner in Choosing the Optimal Marketing Authorisation Pathway
We will assist you in selecting the most suitable type of application for the marketing authorisation, considering the time and costs involved, and perhaps more importantly, the likelihood of a successful registration.
If you are considering introducing a new drug to the market, don’t hesitate to contact us. By leveraging our services, you will benefit from our scientific and regulatory expertise, helping you navigate potential challenges on the road to drug registration.