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UK MHRA Issues Final Call to Comply with Windsor Framework for Medicines by January 2025
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has issued " Call to comply with Windsor Framework arrangements for...
Sharan Murugan
Nov 29, 20242 min read
USFDA: Guidances to Advance Drug Development and Safety Assessments Advance Drug Development and Safety Assessments
The USFDA continues to innovate its regulatory landscape with the release of three important guidance earlier today (27 November, 2024)...
Sharan Murugan
Nov 27, 20242 min read
Australia's TGA: Listed Medicines Evidence Guidelines
Earlier today (20 November, 2024) the Therapeutic Goods Administration (TGA) released Version 4.0 of its Listed Medicines " Evidence...
Sharan Murugan
Nov 20, 20242 min read
Swissmedic Guidance on Product Information for Human Medicinal Products
Swissmedic, the Swiss Agency for Therapeutic Products, has introduced its updated guidance on " Product Information for Human Medicinal...
Sharan Murugan
Nov 16, 20242 min read
USFDA Guidance: Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutics
This USFDA draft guidance" Nonclinical Safety Assessment of Oligonucleotide-Based Therapeutic s" , issued on 15 November 2024, offers...
Sharan Murugan
Nov 16, 20242 min read
South Africa's SAHPRA: Communication to Industry on Quality Variations
The SAHPRA released a " Communication to Industry on Quality Variations " document that addresses updates on the submission requirements...
Sharan Murugan
Nov 11, 20242 min read
South Africa-SAHPRA: Engagement Portal
As part of the South African Health Product Regulatory Authority’s (SAHPRA) Digitalisation Project, we launched the SAHPRA Engagement...
Sharan Murugan
Nov 9, 20242 min read
USFDA Guidance: Study Data Technical Conformance Guide - Technical Specifications
The Study Data Technical Conformance Guide (SDTCG) from the USFDA provides a framework to help sponsors submit standardized study data...
Sharan Murugan
Nov 9, 20242 min read
Australia's TGA Good Clinical Practice (GCP) Inspection Program
Recently last week (30 October, 2024) the TGA released an updated reference material about the " Good Clinical Practice (GCP) Inspection...
Sharan Murugan
Nov 3, 20242 min read
EMA Guidance: Application of the Amended Variations Regulation from 1 January 2025
The European Medicines Agency (EMA) has updated its page on the " Application of the Amended Variations Regulation from 1 January 2025 "...
Sharan Murugan
Nov 1, 20242 min read
SAPHRA News: Implementation of RIMS – Information on eCTD 3.1 Module 1
The South African Health Products Regulatory Authority (SAHPRA) has released a communication " Implementation of RIMS – Information on...
Sharan Murugan
Oct 27, 20242 min read
Swissmedic Guidance: Fast-Track Authorisation Procedure and Temporary Authorisation for Human Medicinal Products
Recntly Switzerland's Swissmedic provided essential information on guidance " Fast-Track Authorisation Procedure " and " Temporary...
Sharan Murugan
Oct 27, 20242 min read
US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
The US FDA released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...
Sharan Murugan
Oct 22, 20242 min read
UK MHRA Guidance: Orphan Medicinal Products, Reference Medicinal Products (RMPs), and Handling of Active Substance Master Files (ASMFs) and Certificates of Suitability (CEP)
The UK Medicines and Healthcare products Regulatory Agency (MHRA) on 18th october, 2024 updated multiple guidances such as " Orphan...
Sharan Murugan
Oct 22, 20242 min read
UK MHRA Guidance: Conditional Marketing Authorisations, Exceptional Circumstances Marketing Authorisations, and National Scientific Advice
On 18th October, 2024 the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their guidance on the processes related...
Sharan Murugan
Oct 22, 20242 min read
USFDA Guidance: Core Patient-Reported Outcomes in Cancer Clinical Trials & Considerations for Long-Term Clinical Neurodevelopmental Safety Studies in Neonatal Product Development
The U.S. Food and Drug Administration (USFDA) yesterday (17 October, 2024) has issued two comprehensive Q&A guidance titled " Core...
Sharan Murugan
Oct 17, 20242 min read
EMA Guideline: Quality and Equivalence of Locally Applied, Locally Acting Cutaneous Products
The European Medicines Agency (EMA) recently updated the guideline on "Quality and Equivalence of Locally Applied, Locally Acting...
Sharan Murugan
Oct 6, 20242 min read
Switzerland's Swiss Medic Guidance: Transfer of Marketing Authorisation
Recently (01 October, 2024) Swissmedic released an updated guidance " Transfer of Marketing Authorisation " which provides detailed...
Sharan Murugan
Oct 6, 20242 min read
Australia TGA: eCTD AU Module 1 and Regional Information v3.2
The Therapeutic Goods Administration (TGA) of Australia has released the latest version, v3.2, (on 13 September 2024) of the eCTD AU...
Sharan Murugan
Oct 2, 20242 min read
USFDA Guidance : Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers
The U.S. Food and Drug Administration (USFDA) has issued comprehensive Q&A guidance titled " Electronic Systems, Electronic Records, and...
Sharan Murugan
Oct 2, 20242 min read