EMA: Scientific Advice Before MAA New Drug Submission

Pharmaceutical companies are required to provide robust evidence as to the risks and benefits of any product they wish to distribute. Generating this sensitive information to make sure their message is clear, compliant, and fully describes how safe and effective a new drug is, can be very complex. This is where EMA scientific advice comes in. Medicine developers can rely on it to make the appropriate product development and communication decisions at any stage in their projects.

Why Is EMA Scientific Advice so Important?

Medicine developers who want to ensure that they are generating what is considered “robust evidence” as to a drug’s benefits and risks can seek EMA scientific advice. This allows them to provide compelling information when submitting their product for approval and to receive the authorisation they need to launch.

MAA (Marketing Authorisation Application) submissions are there to verify that the medicine is of good quality, safe, and effective. It’s up to pharmaceutical companies to prove that it is indeed the case by taking the necessary steps to address any questions that could arise. EMA scientific advice focuses on indicating how to make development decisions that align with the potential concerns of the public, the medical community, and the organisations responsible for approving a product’s distribution. Thanks to this prospective advice, medicine developers can be certain that they will have thought all their answers through well ahead of time.

How to Make the Most Out of EMA Scientific Advice?

It is when pharmaceutical companies develop innovative drugs that EMA input can be especially useful. New medicine often lacks relevant detail as to guidance documents or EU regulations. With no exhaustive monographs and draft documents to consult, they cannot be certain that they will be addressing every point that might be brought up in a convincing manner.

The same goes for developers who choose to observe their own development plans, thus deviating from the scientific guidelines that govern the specific type of product in the works. This solution is also aimed at developers with limited knowledge about the regulations they need to be aware of, such as SMEs (micro, small, and medium sized enterprises) or academic groups.

By requesting protocol assistance or EMA scientific advice during the development phase or before submitting their product for marketing authorisation, these groups can ensure they will not run into any roadblocks.

What Is Protocol Assistance?

In addition to scientific advice from the EMA, medicine developers may also ask for protocol assistance. This specific type of guidance is available to help manufacturers who develop medicines to treat rare diseases. These designated orphan medicines often have no precedents to rely on in terms of authorisation criteria. The role of protocol assistance is to provide indications on how to demonstrate the significant benefit of the product within the scope of the disease it purports to treat. When other drugs already exist, developers must be able to prove clinical superiority over – or similarity to – other medicines currently in use. For instance, market exclusivity may need to be considered.

Consulting With the EMA: The Benefits of External Facilitation

Although organisations such as the EMA or the FDA provide invaluable insight for drug companies, obtaining Health Authority meetings at the most crucial times to drive decisions for product development can be challenging. With the support of an external facilitator, medicine developers can secure scientific advice meetings without having to go through the process of selecting the right advisory organisation. Time constraints are also taken into account, so pharmaceutical companies can engage with Health Authorities just when they need to. This allows them to be able to count on receiving the necessary advice on avoiding major objections regarding their testing procedures or trials without ever stunting their project’s progress.