SA

EMA Scientific Advice

What is EMA scientific advice?

Scientific advice is a flexible process that allows the European Medicines Agency (EMA) to seek input on specific scientific questions coming from EMA experts, national authorities, companies or any other interested party.

 

An expert committee composed of independent scientists conducts an in-depth review of submitted issues and provides the Agency with advice on whether there is sufficient scientific evidence to demonstrate that a medicine is safe, effective and of sufficient quality.

 

How does scientific advice work?

Scientific advice can take different forms:

 

– The Agency might ask for an ad hoc scientific advice on a specific aspect related to the evaluation of medicines under review. This type of advice is aimed at ensuring timely and sound decisions in priority medicines or priority assessment areas.

 

– A scientific advice might be called for when a new active substance enters the European market. The aim of such scientific advice is to gather insights from an Advisory Group of independent experts on whether the data submitted with the application are sufficient for an initial evaluation and indicate that a medicine has a high therapeutic value.

 

– The Agency might ask for regular scientific advice to gather insights on general questions related to the evaluation of medicines.

 

– The European Commission may also request an initial scientific advice, or a regular scientific advice, covering other specific categories of medicinal products than those regulated by EMA.

 

What are the objectives?

EMA aims to illustrate that timely and scientifically sound advice are provided through this process.

 

Scientific advice aims to foster the scientific assessment of medicines at each stage of development, from early clinical investigations to post-marketing studies.

 

It also helps to ensure that EMA’s scientific opinions are based on an appropriate level of scientific evidence and have a sound rationale.

 

How do I submit my scientific advice to EMA?

You can submit your scientific advice at any time.

 

EMA will review the submission and, if necessary, request additional information to facilitate the evaluation before providing an opinion on its scientific validity to EMA’s Management Board.

 

If you want to submit a joint scientific advice with other parties or in view of launching an opinion-sharing initiative, please provide it in the format of a template, which can be downloaded from EMA’s website.

 

What are the benefits?

There are many reasons why you might want to submit your scientific advice to EMA:

 

– The Agency has no obligation to take into account all the opinions submitted by its stakeholders. However, it will review them carefully before providing a formal response. The opinions might also contribute to a better understanding of the issues raised.

 

– The advice will be well informed, as it will be carried out by experts from inside and outside EMA with comprehensive knowledge of pharmaceutical development and regulation.

 

EMA shares its scientific advice with other regulatory agencies around the world, which may benefit from it in their own evaluation processes.

 

For further information, please consult the ‘scientific advice’ section of EMA’s website at: www.ema.europa.eu/ema

 

What are EMA guidelines?

Guidance documents that provide the Agency’s staff and experts with advice on how to interpret legislation, or formal guidance on regulatory procedure.

 

EMA aims to publish as many guidelines as possible in order to facilitate understanding of key issues through transparency and increased legal certainty by providing more detailed information than legislative acts allow for.

 

Is this a new process?

Scientific advice has been a longstanding activity at EMA, which publishes guidelines on the scientific advice process.

 

EMA began providing scientific advice in 1976 and started publishing guidelines in 2002.

 

As of 2014, EMA’s Management Board adopted the ‘Final Rules for Scientific Advice’ to strengthen its commitment to provide key stakeholders with clear guidance on how it will apply the process going forward.

 

How does scientific advice fit in with other processes at EMA?

Scientific advice is a distinct activity from consultation, which carries a different legal basis. It complements cooperation between national agencies and other major stakeholders by supporting their evaluation activities.

 

The Agency also regularly shares its scientific advice through two additional tools: scientific opinion-sharing and scientific advice sharing.