EMA Drug
Approval Process
Summary
- Navigate the EMA approval process with Expert Support
- Our Expertise
- Eligibility Request
- Registration Strategy
- CTD Writing and Publishing
- Management of Registration Procedures
- Orphan Medicines and Rare Diseases
- Advanced Therapies and Innovative Medicines
- Conditional Approval and Accelerated Assessment
- Pilot Project and Innovation Support
- Assessment Reports and EPARs
- Post Approval Responsibilities
- Product Information and Labelling
- Why AzurBio
Our Expertise
A Practical Path to Drug Approval in Europe
At AzurBio, we offer a comprehensive suite of services to guide medicinal products through drug approval in Europe.
We support products seeking an EU route through the centralised procedure, the decentralised procedure, the mutual recognition procedure, or national pathways where appropriate.
We also support separate registrations with Swissmedic and the MHRA when a broader regional strategy is needed.
We understand that the marketing authorisation application is the culmination of years of drug development.
In practice, preparing a robust dossier often requires a multidisciplinary team to develop the Common Technical Document, align product data, confirm regulatory requirements, and ensure readiness for the Agency’s initial assessment.
For sponsors, this stage is where planning, evidence generation, and document quality come together.
For medicinal products for human use, timing and sequencing matter.
The right route depends on product type, innovation level, therapeutic area, and whether the product falls into a mandatory or optional centralised procedure category.
Our team helps clients identify the best regulatory pathway for obtaining marketing authorization efficiently while preserving flexibility for lifecycle plans.
Eligibility Request
The eligibility request is a pivotal early step for companies aiming to determine whether their medicinal product qualifies for the centralised procedure. This formal request allows pharmaceutical companies to confirm whether their product is eligible for a single marketing authorisation covering the European Union (EU) and European Economic Area (EEA).
To be considered for the centralised procedure, a medicinal product must meet specific regulatory requirements set by the European regulatory system. Typically, this includes certain innovative medicines, such as products containing new active substances in relevant areas, advanced therapy medicinal products – including gene therapy and tissue engineered medicines – or products derived from biotechnology processes. The eligibility request is assessed within the EMA framework, with the Committee for Medicinal Products for Human Use (CHMP) determining whether the product falls within the mandatory or optional scope of the centralised procedure.
Pharmaceutical companies are advised to submit their eligibility request 18 to 7 months before the planned marketing authorisation application (MAA). The submission should include a draft Summary of Product Characteristics (SmPC) and a robust justification for why the product meets the eligibility criteria. As the planned submission date approaches, companies should also notify EMA of their intention to submit the MAA during the pre-submission phase. This early engagement with EMA enables companies to clarify the regulatory pathway, anticipate potential challenges, and align their development strategy with EU regulatory requirements.
During the eligibility assessment, EMA determines whether the product meets the legal and procedural criteria for centralised assessment. If the product is considered eligible and the development plan moves forward, the pre-submission phase continues with the appointment of the rapporteur and co-rapporteur and other preparatory interactions ahead of the MAA. This ensures a coordinated and expert-driven initial assessment, ultimately supporting a smoother approval process.
Engaging in the eligibility request process offers significant advantages for pharmaceutical companies. It provides early regulatory clarity, facilitates strategic planning, and opens the door to further EMA support, such as scientific advice and protocol assistance. By leveraging the expertise of the European medicines regulatory network and adhering to EMA’s regulatory requirements, companies can optimize their chances of obtaining marketing authorisation for their medicinal products across the EU/EEA.
In summary, the eligibility request is an essential early milestone in drug approval process, helping drug sponsors navigate the complex European regulatory landscape and paving the way for successful market entry of innovative medicines in the European Economic Area.
Registration Strategy
We design customized regulatory strategies that align with your product’s development stage, therapeutic area, commercialization goals, and the European regulatory system. Our experts build efficient roadmaps, integrating pre-submission meetings and key pathways such as the decentralised procedure and mutual recognition procedure, in addition to national and centralised procedures, to optimize your pathway to market authorisation across the European Union and European Economic Area (via EMA for eligible centralised products or via national competent authorities for other EU routes), Switzerland (via Swissmedic) and the United Kingdom (via MHRA).
The decentralised procedure is designed for medicines that are not authorised through the centralised route, allowing simultaneous national authorisation in several EU member states by submitting dossiers to a Reference Member State and having other Concerned Member States review and harmonize their approvals. The mutual recognition procedure enables a pharmaceutical company to obtain marketing authorisation in multiple EU member states based on an existing national marketing authorisation from a Reference Member State. Harmonization at the national level is crucial to ensure consistency across member states, and assessment reports play a key role in documenting the evaluation and decisions made during these procedures.
CTD Writing and Publishing
We manage document authoring and prepare high-quality, submission-ready Common Technical Document (CTD) modules that meet the rigorous standards of European regulatory authorities, ensuring your submission is complete and compliant. The CTD includes detailed information on the active substance(s) of the medicinal product, as well as other critical data. For EMA centralised applications, the CTD and supporting documents form the basis for the assessment reports and the European Public Assessment Report (EPAR) published by EMA. The marketing authorisation application (MAA) represents the culmination of years of drug development and is submitted as a comprehensive dossier. We publish and submit the dossier in line with EMA CTD guidance for centralised applications, as well as the applicable Swissmedic and MHRA dossier requirements for Switzerland and the United Kingdom.
Management of Registration Procedures
We manage all aspects of the registration process, coordinating centralised procedures (EMA centralised procedure), decentralised and mutual recognition procedures (through the EU regulatory network and national competent authorities), and national procedures through Swissmedic and MHRA.
The EMA centralised procedure involves a scientific evaluation by the Committee for Medicinal Products for Human Use (CHMP), which issues an opinion on whether the medicine may be authorised or not. This opinion is sent to the European Commission, which is the authorising body for centrally authorised products and takes the legally binding decision based on EMA’s assessment and recommendation. Once granted by the European Commission, the centralised marketing authorisation is valid in all EU Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein, and Norway.
EMA works with other committees, including the Pharmacovigilance Risk Assessment Committee (PRAC) and the Committee for Advanced Therapies (CAT), to evaluate applications where relevant. Medicines can receive conditional approval or accelerated assessment if they offer a major public health benefit or meet specific criteria. After approval, post-approval changes must be managed carefully to ensure ongoing compliance, safety, and efficacy throughout the product lifecycle.
Fee incentives or reductions may be available for certain applicants, products, or regulatory activities, including orphan medicines, subject to the applicable EMA fee rules. Regulatory decisions and updates for centrally authorised products are reflected in the Union Register, and EMA publishes a European Public Assessment Report (EPAR) for medicines that have been granted or refused marketing authorisation.
Orphan Medicines and Rare Diseases
The European Medicines Agency EMA has specific frameworks to support orphan medicines and rare diseases.
An orphan medicine is intended for a life-threatening or chronically debilitating condition affecting not more than 5 in 10,000 people in the European Union, or for which the medicine would be unlikely to generate sufficient return without incentives.
Sponsors may still qualify where a treatment exists if they can demonstrate significant benefit.
For orphan medicines, early dialogue with EMA is especially important.
Orphan designation is separate from marketing authorisation, but it can unlock incentives including fee reduction, access to protocol assistance, and, after approval, a period of market exclusivity subject to the applicable rules.
Because the centralised procedure is mandatory for orphan medicines, a clear strategy across designation, development, and submission is critical.
Advanced Therapies and Innovative Medicines
Products in the advanced therapies space often also require particularly careful planning.
This includes advanced therapy medicines, gene therapy, cell-based products, and tissue engineered medicines.
These innovative medicinal products may fall within mandatory EMA review and may involve additional committee input during the scientific evaluation.
Innovative medicines derived from biotech methods or containing new active substances may also be strong candidates for the central route.
For these products, robust CMC strategy, clinical design, comparability planning, and early regulatory dialogue are central to success in the drug approval journey.
Conditional Approval and Accelerated Assessment
In certain cases, medicines may access faster or more flexible routes.
Accelerated assessment may be available when a product is of major public health interest.
Conditional approval can apply when the immediate availability of a medicine addresses an urgent need and the benefit of availability outweighs the risks associated with less complete data.
These tools are relevant to some therapies addressing rare diseases, human immunodeficiency virus, acquired immune deficiency syndrome, oncology, or serious unmet conditions.
For sponsors, however, these routes still require strong planning, convincing data, and a realistic strategy for commitments after authorisation.
A carefully planned programme can make accelerated assessment more achievable when the data package is persuasive and the public health value is clear.
Pilot Project and Innovation Support
EMA and the wider European network continue to explore new ways of supporting innovation, and each pilot project or innovation initiative can create useful opportunities for applicants.
Our team stays close to relevant guidance, procedural updates, and each pilot project that may help clients streamline evidence generation, stakeholder interaction, or submission planning.
This matters most for complex medicinal products, platform technologies, and programmes where early feedback can influence the final dossier strategy.
Assessment Reports and EPARs
A core output of the EU review is the assessment report, which records the scientific reasoning underlying the recommendation.
The rapporteurs prepare the initial assessment, peer review helps refine the analysis, and the final CHMP conclusions are captured in the consolidated assessment report.
This document supports the recommendation forwarded to the European Commission.
For completed centralised procedures, EMA publishes an EPAR for medicines that are authorised or refused.
This makes the scientific basis of the decision more transparent for applicants, healthcare professionals, and the wider public.
It is also a valuable source of benchmarking for sponsors developing similar products.
Post Approval Responsibilities
The work does not end once a product is drug approved.
Post approval obligations are a critical part of the lifecycle.
Sponsors must manage variations, renewals where relevant, pharmacovigilance commitments, safety updates, manufacturing changes, and post approval changes to product information and labelling.
EMA and EU authorities continue to monitor product safety after launch through pharmacovigilance systems, real-world evidence, and ongoing studies.
The Pharmacovigilance Risk Assessment Committee plays an important role in this framework.
Strong post approval management protects patients, preserves compliance, and supports the long-term value of the marketing authorisation.
Product Information and Labelling
We develop, review, and manage your product information, including Summary of Product Characteristics (SmPC), Patient Information Leaflets (PIL), and labelling, including the coordination of the linguistic review process for the centralised procedure, ensuring compliance with EMA product information templates (QRD), as well as the applicable Swissmedic and MHRA requirements for Switzerland and the United Kingdom.
The marketing authorisation holder is responsible for submitting and maintaining product information, including updates based on regulatory assessment outcomes. For centrally authorised products, product information forms part of the European Commission decision-making process and the EMA assessment package. AzurBio supports applicants and marketing authorisation holders in managing product information throughout the lifecycle to ensure transparency, consistency, and compliance with EU requirements, as well as with separate Swissmedic and MHRA obligations where relevant.
Why AzurBio
AzurBio combines high-level strategy with execution.
We support pharmaceutical companies from route selection through marketing authorisation application planning, CTD development, agency interactions, procedure management, product information, and post approval lifecycle support.
We understand the expectations of the European Medicines Agency EMA, the European Commission, and the regulators that make up the wider network in the European Union.
Whether your product is an orphan therapy, an innovative biologic or a medicine seeking expansion through the mutual recognition procedure or the decentralised procedure, our team helps you move through the drug approval process with clarity, quality, and control.