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The timing and planning of the submission of applications and the timetable for assessment of applications is important for applicants and marketing authorisation holders (MAHs), as well for members and experts of EMA's committees.
The European Medicines Agency (EMA) publishes a consultation procedure public assessment report (CPAR) on the opinions prepared by its Committee for Medicinal Products for Human Use (CHMP) following a consultation procedure with EMA on the quality, safety, benefits and risks of ancillary substances incorporated in a medical device.
The EU Innovation Network (EU-IN) working group supports the European medicines regulatory network in facilitating the development of innovative medicines and associated technologies in the European Union (EU).
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.
You can download structured JSON data files to automatically access and retrieve up-to-date information and documents from the European Medicines Agency’s (EMA) website. These data files specifically target use via automated systems. Examples of the information available include data on medicines, guidelines, and documents along with their...
PRIME is a scheme run by the European Medicines Agency (EMA) to enhance support for the development of medicines targeting unmet medical needs. It is based on early dialogue with companies to optimise development plans and speed up evaluation.
The European Medicines Agency (EMA) makes available answers to the most frequently asked questions on maximum residue limits (MRLs).
Certain biological substances and substances that do not have any effect on the body may fall outside the Maximum Residue Limit Regulation. Such substances do not require a full MRL evaluation.
The European Medicines Agency (EMA) makes available guidance on how to prepare and submit a maximum residue limits (MRLs) application.