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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US FDA Draft Guidance: Drug Interaction Information in Human Prescription Drug and Biological Product Labeling
The US FDA released a draft guidance on 21st October 2024 outlining the recommendations for " Drug Interaction Information in Human...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
UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
Sharan Murugan
Oct 2, 20242 min read
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...
Sharan Murugan
Sep 28, 20242 min read
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...
Sharan Murugan
Sep 25, 20242 min read
USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document , titled “ An Acceptable...
Sharan Murugan
Sep 25, 20242 min read
USFDA Med Dev Guidance: Biocompatibility Testing and Accreditation Scheme for Conformity Assessment (ASCA) Program
USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...
Sharan Murugan
Sep 22, 20242 min read
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...
Sharan Murugan
Sep 22, 20242 min read
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...
Sharan Murugan
Sep 21, 20242 min read
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 15, 20242 min read