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Mag

EMA explains GMP and GDP flexibilities amid COVID-19

The European Medicines Agency (EMA) and its counterparts at the European Commission and Heads of Medicines Agencies have updated their questions and answers guidance on regulatory expectations for medicinal products amid the coronavirus disease (COVID-19) pandemic, adding a new section laying out temporary flexibilities for good manufacturing practice (GMP) and good distribution practice (GDP)....[EMA]

03

Lug

Generici e biosimilari. Presentato alle Istituzioni il “Manifesto per la ripartenza”

Una nuova politica industriale che garantisca sostenibilità al comparto pharma, assicurando a tutte le sue componenti regole chiare, certe e semplificate e ridia maggiore autonomia e capacità...

30

Giu

The COVID-19 Pandemic Sheds Light on the Over-Reliance on Offshore Drug Manufacturers

Four ideas to bring drug substance and drug product manufacturing back to the U.S....[ContractPharma]

30

Giu

Active Pharmaceutical Ingredients: How dependent is India on China

Despite calls to reduce imports from China, India's reliance on its hostile neighbour for the pharmaceutical sector remains. At least 60% of India's Active Pharmaceutical Ingredient (API) requirements...

26

Giu

EMA nominates executive director to replace Rasi

The European Medicines Agency’s (EMA) Management Board on Thursday nominated Emer Cooke from a short list of candidates to succeed Guido Rasi as the agency’s next executive director...[EMA]

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