The pharmaceutical and medical device development landscape is complex, so companies looking to market their products in the European Union (EU) and European Economic Area (EEA) face a daunting challenge.
The process of marketing medicines and medical devices in the EEA involves navigating intricate procedures and stringent requirements and gaining a thorough understanding of the European Medicines Agency (EMA) and how businesses can best work with this agency.
This article provides an overview of the processes pharmaceutical and medical device developers must go through, outlines the challenges associated with securing authorisation in the EEA and details the ways that companies can maximise their chances of success. This includes partnering with a pharmaceutical or medical device consultancy to tap into specialised experience and expertise that may not be available in-house.
Marketing authorisation applications and the EMA
The EMA is responsible for authorising and monitoring medicines in the EU. Their responsibilities include facilitating the development of medicines and evaluating marketing authorisation applications as well as monitoring the safety of medicines and providing information to professionals and patients.
Under European legislation, many medicinal products can only be placed on the market after marketing authorisation has been obtained from the EMA. This regulatory framework has also been adopted by EEA member states (Iceland, Liechtenstein and Norway) and is reproduced in Switzerland. (References to the EU below also cover these countries.)
In the EU, medicines can be authorised via a centralised or national route. The majority of new, innovative drugs are evaluated by the EMA via the centralised route. This is mandatory for certain types of medicines (for example, those for HIV/AIDS, cancer, diabetes, or neurodegenerative diseases). Whereas generic medicines, older drugs, and medicines available without a prescription are assessed and authorised at a national level. Ensuring a drug is submitted via the correct path is a key step in the assessment process.
An overview of the centralised marketing authorisation process for pharmaceuticals
1. Pre-submission
After the research and development of a new drug, sponsors will meet with EMA representatives to discuss the upcoming application. EMA representatives will share their specialist knowledge and offer advice to ensure the application complies with legal and regulatory requirements to avoid unnecessary delays.
2. Application
Drug sponsors put together a comprehensive dossier, including information about:
- The results of laboratory studies
- The benefits and side effects observed in patients
- How risks will be managed
- What information will be given to doctors and patients
They’ll also need to provide information about the patients the drug is designed for, the properties of the medicine and how it works in the body, and offer evidence that the testing, manufacturing and trials comply with regulations.
3. Evaluation
The Committee for Medicinal Products for Human Use (CHMP) evaluates the application to assess whether the drug’s benefits outweigh its risks. The CHMP works alongside a team of assessors in national agencies, other EMA committees and external experts. Patients and healthcare professionals might also play a role in advisory groups.
The CHMP will ask questions and might request clarification or additional information. They may also raise objections or concerns. Final recommendations are reached by formal vote.
4. Authorisation
While the EMA can make a recommendation, it’s the European Commission which takes the final, legally binding decision on whether a medicine can be marketed in the EU. This is issued within 67 days of the EMA’s recommendation.
5. Post-authorisation
Initial authorisation is valid for 5 years. The EMA and EU member states continue to monitor whether the drug is safe and effective.
Looking to market your product in the EU and EEA?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s TalkConformity assessment of medical devices
The process for gaining marketing authorisation for medical devices in the EU differs from that of pharmaceuticals. Instead of marketing authorisation, developers complete a conformity assessment to demonstrate the safety and performance of their medical device before a CE (Conformité Européenne) mark can be placed on it. This is regulated by EU member states but the EMA is involved in the process.
Devices are classified by their intended purpose and inherent risks. This classification determines the correct conformity assessment route. However a typical process would see the applicant gather technical documentation and clinical data to demonstrate that a medical device was safe, performed correctly and complied with all legal requirements. They would also need to conduct risk analysis and implement any risk control measures required.
For higher-risk devices they would then need to engage the relevant bodies who would review the information provided and conduct on-site audits before making a decision. Only when the full process is completed can the CE mark be applied.
The challenge of marketing medicines and medical devices in the EU
The process of gaining authorisation to market medicines and medical devices in the EU is complex and requires significant time, expense and expertise. At the core of this challenge lies the need for extensive trials and data collection.
Anyone hoping to market a medicine or medical device in the EU must prepare comprehensive dossiers detailing all aspects of their product – from technical data to clinical evidence. Meticulous attention must be paid and highly skilled personnel are required. What’s more, research, development and regulatory processes are high-cost which can put significant strain on budgets.
These resource-heavy requirements don’t end when a drug or device gains authorisation. The complexities of the EU’s legal framework for pharmacovigilance demands long-term commitment from manufacturers. As products become more complex, legislation evolves and the industry faces increasing demands for transparency, specialised knowledge, expertise and experience become ever more essential.
What businesses can do to overcome these challenges
Pharmaceutical companies can give themselves the best chance of overcoming the challenges of the EU regulatory landscape by investing in expertise from the earliest stages of development. This will allow them to stay ahead of current regulations and guidelines and keep up to date with similar successful applications. Companies should engage with regulatory authorities early in the process, to take advantage of advice provided by the EMA and other agencies. Getting a strategy in place as quickly as possible is advisable. This should consider all potential scenarios and contain contingency plans to help teams navigate all eventualities and avoid delays.
Building a strong team is essential. This team should be multidisciplinary, with experience across every aspect of development and regulation. However, many companies may not have this depth and breadth of expertise in-house. Partnering with a pharmaceutical and medical device consultancy solves this problem as it allows businesses to access high-level expertise and experience without expanding their team. Pharmaceutical and medical device consulting unlocks best practice for everyone. These consultancies can offer help throughout the regulatory process, from explaining complex regulations to preparing in-depth dossiers and managing relationships with agencies.
How MWB can help
Our team of experienced professionals have an in-depth understanding of the entire regulatory process for marketing medicines and medical devices in the EU. They can offer expert advice or partner with you for some or all of the steps that are involved. This could include guiding you through marketing authorisation applications, building strong relationships with the European Medicines Agency and demystifying the EU legal framework for pharmacovigilance.
MWB Consulting can also help you establish an effective regulatory strategy, prepare detailed and accurate dossiers and understand ever-changing regulations to save time, control costs and maximise your chances of gaining authorisation to market in the EU.
Looking to market your product in the EU and EEA?
Contact us today for an initial, free-of-charge discussion with a senior consultant about your project.
Let’s Talk