Pharmaceutical Reference Standard – Guidance Update - SFDA
Post-Authorisation Procedural Advice for Users of the Centralised Procedure – Updated guideline EMA
Imports & Exports of Therapeutic Goods - Pakistan (DRAP)
Guideline for Registration of Drug-Medical Device & Med.Dev-Drug Combo Products - MALAYSIA -NPRA
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
UK-MHRA Guidance on Pharmacovigilance Procedures
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
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
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU
Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA