EMA	European Medicines Agency: an agency of the EU, responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the European Union. It began operating in 1995. EMA does not regulate tobacco, food, or medical devices, unlike the FDA. The EMA works in collaboration with the EU competent authorities for human medicines and for veterinary medicines.
EU	European Union. Currently composed of 28 member states. Three additional countries (Norway, Iceland, and Liechtenstein) also collaborate closely in the EMA activities. The EMA’s scientific committees and its network of 4,500 scientific experts are nominated by the member states.
FDA	Food and Drug Administration: the federal agency responsible, among other activities, to ensure that human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use, are safe and effective, including for pediatric medicines.
MAA	Marketing Authorisation Application
MAH	Marketing Authorisation Holder
NDA-BLA	New Drug Application–Biologic License Application. These are FDA processes (see references for further details)
Orange Book	List of FDA-approved drug products with therapeutic equivalence evaluations.
PeRC	The FDA Pediatric Review Committee reviews all activities under BPCA and PREA. PeRC is consultative to FDA review divisions (ie, PeRC makes recommendations that are not binding, but usually followed)
PDCO	EMA Paediatric Committee: the committee at the European Medicines Agency that is responsible for assessing the content of applications for pediatric investigation plans (with or without deferrals) or waivers, and adopts Opinions on them. The PDCO Opinion is then transformed into a Decision signed by the EMA Executive Director.
PIP	Paediatric Investigation Plan (EU): a pediatric development plan aimed at ensuring that the necessary data are obtained through studies in the pediatric population and when it is safe to do so to support the authorization of a medicine for pediatric patients. The plan may include quality measures (on the pharmaceutical forms), nonclinical and clinical studies.
PRAC	Pharmacovigilance Risk Assessment Committee (EU)
PSP	Pediatric Study Plan (US): a pediatric development plan including an outline of the pediatric study or studies that the sponsor has to conduct, including study objectives, design, age groups, relevant endpoints, statistical approach, deferral and/or waiver if applicable.
PPSR	Proposed Pediatric Study Request (US): an application submitted to the FDA to receive a formal Written Request for pediatric studies under BPCA.
PUMA	Paediatric-Use Marketing Authorisation (EU): a type of marketing authorization for medicines that are already authorized and no longer covered by supplementary protection certificates or qualifying patents, and are to be exclusively developed for use in the pediatric population.
Qualifying patent	Patent qualifying for the granting of an SPC in the EU. To qualify for SPC protection, a patent should be in force in the country of interest, and there must be a valid marketing authorization in that country to place the product on the market. Not all patents on a product are qualifying patents; briefly, only patents covering the active ingredient (or its manufacturing, or its application) can be considered as qualifying patents.
SPC	Supplementary Protection Certificate: an Intellectual Property right that grants an extension of up to 5 extra years to the (qualifying) patent, available in many European jurisdictions for human medicinal products.
Written Request (WR)	FDA Written Request: a specific document in which the FDA requests submission of certain studies to determine if the use of a drug or biological product could have meaningful health benefits in the pediatric population. If a pharmaceutical company performs the studies in compliance with the WR, a reward will be granted.