All Active pharmaceutical ingredients (API) articles
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Industry newsHarmonisation, fast track and reliance activities in focus at recent EDQM meetings
Leaders from the European Directorate for the Quality of Medicines & HealthCare (EDQM), which is home to the European Pharmacopoeia (PhEur), participated in two public outreach events in May 2026. The first was on pharmacopoeial harmonisation in collaboration with United States Pharmacopoeia (USP), and the second on fast ...
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JournalComparing China Drug Master Files with the EU and US
This is the third article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements.
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JournalChoosing the right registration pathway for the China drug master file: an essential analysis of options
Regulatory Rapporteur April 2024 | Volume 21 | No.4 Abstract Building upon the foundational insights presented in the first article of our China series, this subsequent piece delves deeper into the intricacies of China’s drug master file (DMF) ...
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JournalChina drug master file: registration pathways and requirements
This is the first article in a six-part series that will focus on the regulations in China’s drug market. There will be different topics each month with the initial focus on the drug master file (DMF) filing process followed by the drug registration process and pharmacovigilance requirements. ...
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JournalThe transition period of the new API framework in Brazil is coming to an end
The new active pharmaceutical ingredients regulatory framework in Brazil begins August 2023
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EditorialThe region walking the regulatory walk
Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.