Quality, Efficacy and Safety Studies on Medicines (6 lots)

Item Description:

The European Medicines Agency (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 European Medicines Agency (referred to below as ‘EMA’ or ‘the Agency’) is planning to award the contract(s) resulting from the above procurement procedure. The procurement documents consist of the contract notice in the Official Journal of the European Union, this invitation letter, the tender specifications and their annexes including the draft contract. All documents are available

Subject of the tender

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.

Technical specifications

The Agency considers that it may require the services of research organisations to perform pre- and post- authorisation quality, efficacy and safety research to generate data and information to support regulatory decision-making in the human and veterinary medicines regulatory domain. Research topics are those with high public and animal health relevance and with a European impact. The scope of the funding covers both nationally and centrally authorised products, including vaccines. The results obtained from this research will subsequently be assessed by the responsible Agency Committee(s) regarding the need for regulatory action and any further research.

To conduct this research the Agency as a first step seeks to put in place through this procurement procedure multiple framework contracts with a maximum of 10 research organisations per Lot, for a period of four years each. Framework contractors will subsequently be invited to submit tenders for specific studies on topics identified by the Agency in collaboration with its Scientific Committees as part of the scientific evaluation of the benefit-risk profile of authorised medicinal products.

The specific studies may concern research under Lots 1 to 6 (as described in detail in section 3.3. of the Technical Specifications); tenderers may apply for one or several Lot(s):

• Lot 1: Pre-clinical research
• Lot 2: Veterinary studies
• Lot 3: Statistical research
• Lot 4: Qualitative research
• Lot 5: Pharmacoepidemiological research
• Lot 6: Quality of medicines

To help provide an understanding of their ability to perform the type of research described in the Lot(s) they apply for, the tenderers should provide information on expertise and experience relevant to this type of research (see also section 15 of of the Technical Specifications, Selection criteria: technical and professional capacity). The tenderers are not expected to have all the required expertise or data sets ‘in house’ or in one location. However, the tenderers are expected to have access to a network of scientists where one or more elements of the expertise described are available as needed (see also sections 4.2. Subcontracting and 4.3. Joint offers of the Technical Specifications).

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