Science and Regulatory
 Section Overview
The Science & Regulatory area is designed to make the latest regulatory and scientifice guidelines as well as quality articles and papers pertaining to generic medicines available in a simple and easy to find format. The section is divided into several areas:
Product Development
Generic Medicines: The latest quality guidelines for generic medicines from the CPMP along with the new guidelines for investigating bioequivalence and bioavailability. Expert articles and papers from leading European experts on bioequivalence can also be found under this heading.
See also the section on:
» Biosimilar Medicines: The
most recently adopted guidelines from the EMEA pertaining to the comparability
of biotechnology-derived products are available in this section, along
with the legislative documents constituting the legal & regualtory framework
for biosimlar medicines, conference and seminar notes & notices, scientific papers
and articles, and the EGA’s “FAQ
on Biosimilar Medicines”.
Marketing Authorisation
The texts of the new legislation on pharmaceuticals recently adopted by the European Parliament and the Council in the context of the “Pharma Review 2001” can be downloaded here. This area also presents articles, papers, and conference presentations & notes from industry experts and regulatory officials on topics related to the marketing authorisation process.
Post-Authorisation Surveillance
Latest news on European pharmacovigilance activities, including working documents from the medicines authorities, training opportunities and up-dates on regulatory developments.
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