Imports & Exports of Therapeutic Goods - Pakistan (DRAP)
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
EC MDCG Guidance on Legacy Medical Devices, Repackaging Data
Data Standards for Drug & Biological Product Submissions Containing Real-World Data - USFDA
Updated Guideline on Registry-Based Studies (EMA)
Finland adopts New Act on Clinical Trials Legislation (FIMEA)
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals
South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application
Philippines FDA: Guidelines on the Licensing of Retailers of Medical Devices
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
European Commission’s MCGD New Guidance on Classification of Medical Devices
European Commission (EC) updated guide on Good Lay Summary Practice
USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices
USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
FDA’s finalized “Interpreting Sameness” Gene Therapy Products Guidance
MHRA Guidance on need to Review Registration of Medical Devices