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GMP News

GMP Problems with critical Medicinal Products - what now?

A recent EU Statement of Non-Compliance with GMP attests an Indian pharmaceutical company that it does not meet GMP requirements. The problem was that critical medicinal products could have been potentially affected.

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EU adopts Supply Chain Law - Implications for pharmaceutical Companies

On 24th of May 2024, the EU member states adopted the European Supply Chain Law which requires companies of a certain size to monitor and prevent negative impacts on human rights and the environment from their supply chain activities.

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NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles

China's National Medical Products Administration (NMPA) has published an announcement regarding the application of the principle of the ICH Q2(R2) and Q14 Guidelines. Applicants are required to conduct studies in accordance with the requirements of ICH Q2(R2)/Q14. The two Guidelines are applicable to relevant studies starting from 24 November 2024 (based on the time point of the trial record).

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