New pharmacovigilance legislation was adopted by the European Parliament and European Council in December 2010. EMA is the regulatory body responsible for implementing much of the new legislation and is developing a framework for compliance and delivery of key requirements. The legislation will be effective from July 2012.
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Generics
News
- FDA approves generic teriparatide and levetiracetam
- US generics launch and approval for Dr Reddy’s and Lupin
- Five Chinese companies join UN’s MPP for Covid-19 medicines
- South Korean companies to make generic Bridion and COVID-19 drugs
Research
- Japan’s drug shortage crisis: challenges and policy solutions
- Saudi FDA drug approvals and GMP inspections: trend analysis
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
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Biosimilars
News
- Canada approves pegfilgrastim biosimilar Pexegra
- Insulin aspart and denosumab biosimilars approved in US
- FDA approves tocilizumab biosimilar Avtozma
- January 2025 biosimilar approvals in Europe
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