News dal mondo
US-EU Mutual Recognition Pact Adds Luxembourg, Netherlands
The European Medicines Agency (EMA) on Tuesday announced that Luxembourg and the Netherlands have joined the mutual recognition agreement for good manufacturing practice (GMP) inspections between the US Food and Drug Administration (FDA) and EU member states. ..[EMA]
Accordo storico UE-USA sul reciproco riconoscimento dei prodotti farmaceutici
L'Unione europea e gli Stati Uniti hanno raggiunto un accordo volto a ridurre le barriere e ad aumentare gli scambi in una serie di settori,...
Removing Gaps in Data Integrity
FDA guidance is expected to improve industry practices, but work is also needed to bridge disparate industry and software engineering standards....[PharmTech...
Improving Prospective Product Development Methods Derived from Management-Based Regulatory Guidelines
To rapidly achieve high-quality pharmaceutical manufacturing processes, the industry must focus on developing prospective, management-based approaches...
Is it Time to Update cGMPs?
Industry practice has changed radically over the past five decades. Can laws published in the 1960s still ensure pharmaceutical quality and safety...