In Europe, the development, authorisation and monitoring of medicines is an extensive ecosystem. The regulatory authorities in each Member State, the European Medicines Agency (EMA), and the European Commission all work together to ensure that patients have access to high-quality, effective and safe medicines. To be successful in the EU, a drug developing company must understand the European regulations and how to navigate through the approval process, which may not always be easily understood.  

EMA has worked across the EU to protect public health since 1995, by assessing medicines to rigorous scientific standards and by providing partners and stakeholders with independent, science-based information about medicines. It is, however, not within the scope of EMA to decide whether a medicine can be marketed. Neither does EMA develop nor change drug regulations or have a direct influence on the price or availability of the medicines. The role of the authority is strictly to scientifically evaluate marketing authorisations for medicines.

The European Commission is the authorising body that approves, denies, suspends, or revokes marketing authorizations. The European Commission takes a legally binding decision based upon EMA’s recommendation. EMA does not approve all drugs that are used in EU countries, each individual nation may choose to approve drugs locally regardless of EMA approval.

In the EU, there are two main routes for authorising medicines: a centralised procedure and a national procedure.

Centralised procedure: Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing authorisation application to EMA. This route is compulsory for gene- and cell therapies as well as new medicines targeting cancer, neurodegenerative diseases and rare diseases. Based on this authorisation, the company can market the medical product and make it available to healthcare professionals and patients throughout the EU. Once granted, 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.

National Procedure: This procedure is for the company who is planning to market the drug in one of the European countries. In the EU, each state has its own national authorisation procedures that don't need to follow a centralised process. most generic medicines and medicines available without a prescription are assessed and authorised at national level in the EU.

If a company aims for marketing authorisation in several EU Member States for a medicine that is outside the scope of the centralised procedure, there are two alternatives.

The mutual-recognition procedure, whereby a marketing authorisation granted in one Member State via a national process obtain marketing authorization in another EU member state. Products can only be marketed using the Mutual Recognition if they have already been approved via the national procedure by at least one member state.

The Decentralised procedure is for products that have not yet been authorized in any EU state and do not fall under the mandatory centralised process. The developer can apply for simultaneous approval in more than one Member State. One of the proposed Member States will act as Reference Member State and perform the initial evaluation of the product and if the other Member States agree, all issues are resolved and the application is successful, each Member State will then issue a market authorisation permitting the product to be marketed in their country.

To market a medicinal product in the EU, a marketing authorization application (MAA) must be submitted to EMA. EMA provides companies with guidance on the type of information that needs to be included in the submission. As a developer, you can request scientific advice and direction from EMA on the best methods and study designs to generate robust information. The Common Technical Document (CTD) assemble all the quality, safety and efficacy information in a common format and this dossier is submitted to the regulatory authorities as an MAA.  

The data submitted must comply with EU legislation and should include a range of information, including on the way the medicine is manufactured, its effects in laboratory studies, benefits and side effects observed in patients, and how risks will be managed, as well as the proposed information to be provided to patients and doctors.

After evaluating the application, the CHMP will adopt an opinion and make a recommendation on whether a medicine should be granted a marketing authorisation and, if so, under which conditions of use. The final, legally binding decision on whether the medicine can be marketed in the EU is taken by the European Commission.

Once a medicine has received an EU-wide marketing authorisation, decisions about pricing and reimbursement take place at national and regional level. Health technology assessment (HTA) evaluates the relative effectiveness which is used to estimate the value of the product in relation to other treatment options. This assessment is then used to determine reimbursement and/or accepted pricing.

Finally, when the drug is authorized, EMA and national authorities continue to monitor its safety through defined pharmacovigilance methods and regulations as changes to packaging, adjustments of the manufacturing process, and every new service provider may be the cause for a regulatory variation.

European approval can occur through different routes, depending on the nature of the drug and the preference of the manufacturer. Over the last ten years, NDA has supported over 40% of the new medicinal products approved in Europe, welcome to start a conversation by using the form below.