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
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
USFDA's Novel Excipient Review Pilot Program
Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices
Swissmedic Updates Forms for New Authorization, Variations & Extensions-Switzerland
Updated Guidance for e-Submissions for CEP applications
Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
MHRA's New & updated Innovative Licensing and Access Pathway - UK