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The European Medicines Agency can give scientific advice to companies on the appropriate tests and studies in the development of veterinary medicines. This is designed to facilitate the development and availability of high-quality, effective and acceptably safe medicines.
The European Medicines Agency (EMA) publishes opinions on the qualification of innovative development methods and letters of support for novel methodologies that have been shown to be promising in the context of research and development into pharmaceuticals.
The European Medicines Agency (EMA) offers training to support stakeholders in meeting their pharmacovigilance obligations when using EudraVigilance. Training is important to ensure that users understand its functionalities and submit high quality data which adhere to standards that allow for adequate monitoring of the safety of medicines and the...
The European Medicines Agency (EMA) maintains a list of class waivers for medicines that are not required to submit a paediatric investigation plan (PIP) as part of a marketing authorisation application. These medicines are likely unsafe or ineffective in children, lack benefit for children or are for diseases and conditions that only affect the...
This page provides answers to specific questions from companies intending to apply for a paediatric investigation plan (PIP), waiver, deferral or product-specific waiver. Information is also available for companies that already have an agreed PIP.
This page lists the templates and forms required by companies wishing to submit a paediatric application.
This section provides information on the European Medicines Agency's activities relating to paediatric medicines during the research and development stage. This includes guidance on paediatric investigation plans (PIPs) and other paediatric applications.
Advice for applicants for paediatric medicines, including information on how to submit their applications, what templates and forms to use, the deadlines they need to meet, and the contact points they can reach out to.