Added 1976-08-04 04:52:36
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The Regulator
Post Date:
2017-09-25 16:52:36

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The Regulator brings you news and all updates published by the two leading regulatory agencies globally, the European Medicines Agency (EMA) and the Food and Drug Administration (FDA). This application is designed for regulatory affairs professionals, as well as all healthcare & health-system workers who are impacted by, or have an interest in, global pharmaceutical developments.

The Regulator presents information across three categories: EMA, EMA Committee Meeting Reports and FDA.

For the EMA, The Regulator provides all news and press releases relating to CHMP Opinions, European Commission (EC) Decisions, new and updated EPARs, Orphan Designation Decisions, Paediatric Investigation Plan (PIP) Opinions and Decisions, new and revised regulatory or scientific guidelines, public consultations, inspections and job vacancies within the agency. In addition, there is full access to all committee meeting reports for:
– Committee for Medicinal Products for Human Use (CHMP)
– Committee for Medicinal Products for Veterinary Use (CVMP)
– Committee for Orphan Medicinal Products (COMP)
– Committee on Herbal Medicinal Products (HMPC)
– Paediatric Committee (PDCO)
– Committee for Advanced Therapies (CAT)

For the FDA, The Regulator provides comprehensive information from all areas of the administration’s responsibility, which broadly includes the safety and efficacy of human and veterinary medicinal products, devices, food and cosmetics. Examples of specific updates which The Regulator will provide are all news relating to drugs, vaccines, biologics, food and cosmetics, product recalls, MedWatch safety alerts and updates to consumer health information.

This application was developed in consultation with a regulatory affairs professional to improve efficiency in staying up to date with regulatory developments and the ever changing global pharmaceutical environment.

This application is not affiliated with the EMA or FDA, but presents the publicly available information published by these agencies in an aggregated manner.


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