Dear ETPN members, dear colleagues of the European community of Nanomedicine, we are glad to share with you a new potential source of funding for research in nanomedicine through a new tender of the European Medicines Agency (EMA) in order to support primary research into the quality, safety and efficacy of medicines, notably including nanomedicines. The funding aims to support research on human and veterinary medicines in order to inform regulatory decision making. All information & documents to apply for this opportunity is available in this article. APPLY before April 30 2021 at noon (deadline extended)!

How is Nanomedicine addressed by this tender?

There are 6 lots of funding covering a range of areas including quality of medicines (lot 6) but also encompassing epidemiology, pre-clinical studies and statistics. Lot #6 dedicated to quality- related studies would be of high interest for stakeholders in Nanomedicine. They include studies to:

1. investigate the origin of harmful impurities in medicines
2. develop understanding of, and regulatory  response to, nanotechnology and new materials in medicinal products (e.g. characterization of these drug delivery systems/materials and how they interact with biological systems)
3. evaluate the potential impact on the quality of veterinary medicinal products when administered via drinking water to farm animals due to the different water qualities used across the EU.

Download the full description of the call for proposals

Please download the full Procurement procedure “Quality, efficacy and safety studies on medicines”, reference no. EMA/2020/46/TDA by clicking on this link The document describes the types of research sought, see specifically pages 11-13 for the quality research, lot 6.

Key facts

• Total budget for lot 6 on quality : 3.000.000€
• Project duration: 4 years
• Budget per study may be approximately €60,000 to €500,000 
• Joint proposals are permitted

How to apply?

• Deadline is EXTENDED until April, 30, 2021 at noon (CET)
• Due date for submission of questions is Wednesday 21 April 2021 cob
• All information and application procedure is availaible on the landing page of this EMA funding tender by clicking on this link.

Context

The benefit-risk balance of a medicinal product at the time of its initial marketing authorisation is based on evidence generated by a clinical development programme. Appropriate risk management systems are adopted to ensure the safe and effective use of the medicine post-authorisation. Building knowledge throughout the lifecycle of a medicinal product is therefore critical in fully characterising the safety and effectiveness profile of a medicine and thus its benefit-risk balance while it is marketed. 

While valid scientific evidence generated by an MAH remains at the core of regulatory evaluation, additional and relevant data and information available from alternative sources or new data may be generated to further inform regulatory decision-making. Technological and scientific developments of recent years provide unprecedented opportunities to further support regulatory decisions based on the best available scientific evidence. 

The EMA needs to have access to data sources and scientific expertise in selecting and using methods appropriate to a wide range of quality, efficacy and safety questions and in understanding the evidence needed for regulatory decision making.

About the EMA

The European Medicines Agency (“the Agency” or “EMA”) is a decentralised agency of the European Union (EU) based in the Zuidas area of Amsterdam. EMA’s mission is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

The EMA:

• supports medicines development by giving scientific advice and providing guidance to developers of medicines;
• carries out scientific evaluations of medicines for human and veterinary use that are the basis of the European Commission’s decision on whether a medicine can be authorised for marketing throughout the EU
• monitors the safety of medicines in the EU throughout their lifespan
• provides information on medicines to healthcare professionals and patients.

For more information, please visit the EMA website : https://www.ema.europa.eu/en