Under the Falsified Medicines Directive the European Union (EU) is introducing new rules for importing active pharmaceutical ingredients (APIs) for human-use medicines into Europe. From 2 January 2013, all imported APIs were required to have been manufactured in compliance with standards of GMP at least equivalent to the EU’s GMP and as of 2 July 2013 this compliance must be confirmed in writing by the competent authority of the exporting country. Alternatively, the country may request listing (on the ‘white list’) if the country’s rules for GMP are equivalent to those in the EU before the EU will grant entry of the API.
- Home
-
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
- Generic medications in the Lebanese community: understanding and public perception
- Community pharmacists’ understanding of generic and biosimilar drugs: Lebanon case study
- Reshaping landscape of Japanese generics market – uncertain future of universal health insurance
- Impact of e-bidding procurement on generic omeprazole injection prices in Thailand
-
Biosimilars
News
- Dr Reddy's launches bevacizumab biosimilar Versavo in the UK
- EMA recommends approval of ustekinumab biosimilar Pyzchiva
- FDA approves interchangeable adalimumab biosimilar Simlandi
- EC approval of ranibizumab biosimilar Rimmyrah
Research
- Questioning the need for ethnic sensitivity assessments for biosimilar monoclonal antibodies
- ANVISA's role in biosimilar medicine regulation and innovation promotion
- Infliximab discontinuation in patients with originator retransition vs biosimilar continuation
- Biological therapies for psoriasis: evaluating durability and persistent benefits
- MORE EDITORIAL SECTIONS
- Search
Comments (0)
Post your comment