Regulatory Blog

Pakistan's Guidelines on Therapeutic Good Import & Export Permissions

USFDA Electronic Submission of IND Safety Reports - Technical Conformance Guide

USFDA Guidance on Electronic PostMarketing Safety Reporting

Guidance on Classification of Rehabilitation Medical Devices -Malaysia’s MDA

Guidelines on Labeling Requirements of Drug Products under Maximum Retail Price - Philippines FDA

USFDA Guidance on “Pharm. Quality/CMC Data Exchange" and Drug Products containing Nanoparticles

SFDA's Product Classification Guidance

Pakistan (DRAP) Draft Guidelines on FP Labeling & Packaging and BA-BE Guidelines

Malaysia’s MDA- Draft Medical Device Labeling Guidance

FDA's Considerations for Waiver Requests for pH Adjusters in Generic Drug Products

FDA's Bioavailability Guidance for NDAs or INDs- General consideration

Draft Guidleline on Change Notification For Registered Medical Device-Malaysia’s MDA

FDA's MAPP on Complex Product Classification for Generic Development

HPRA Guide to Parallel Imports of Human Medicines - Ireland

FDA's Draft Guidance on Cybersecurity in MD: Quality System Consideration & Content of Premarket Sub

EMA Draft Guidance- How To Approach the Protection Clinical Trial Information System (CTIS)

ICH-Draft Guideline on Pediatric Extrapolation & FInal Guidance on Considerations for Clinical Study

Voluntary GVP Inspection on Pharma Product Registration Holders- Malaysia’s NPRA