Drugs - Aug 2019

  • China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing

  • EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US.

  • South Korea : Five-year Master Plan for Clinical Trials Development

  • Thailand : Criteria and Conditions for Drug Dossier Registration Review, Draft version

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Europe - May 2020

Denmark: New rules mean non-serious adverse events may also need to be reported EU: Application of Regulation (EU) 2017/745 postponed by one year EU: Continued use of lead as a thermal stabiliser in P

EU: MDR delayed to 26 May 2021

Application of the Medical Devices Regulation (MDR) has been deferred by one year, until 26 May 2021, for fear of shortage or delay in getting essential medical devices needed to combat Covid-19. The

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