STM publisher Elsevier, Netherlands, has announced that its online resource for authoritative drug safety data, PharmaPendium, has expanded its content offering with a new release containing the European Medicines Agency's (EMEA) European Public Assessment Reports (EPARs). The addition of this content makes PharmaPendium the only source of consolidated, searchable access to US Food and Drug Administration (FDA) and EMEA drug approval documents on a single site, with a single search. EMEA is the European agency for the evaluation of medicinal products.
Companies operating globally are expected to benefit from this new content offering as it provides critical insights into the EMEA regulatory point of view, the agency's analysis underlying drug approval and the qualifications put on that approval. The EMEA's EPAR documents cover medicines assessed by the Committee for Medicinal Products for Human Use (CHMP). EPAR documents include efficacy, indication, safety and pharmacokinetics data and mode of action information.
The EMEA database on PharmaPendium makes readily accessible about 80,000 pages of searchable documents for more than 300 active ingredients approved for the European market - some not approved in the US. It also presents preclinical and clinical toxicity and adverse effects data manually extracted from these documents. General product information documents are also included. The EMEA Documents database is included as part of PharmaPendium licensing agreements at no additional fee and the content is automatically available to all users.
