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Sharan Murugan
Apr 29, 20231 min read
South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH
Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...
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Sharan Murugan
Apr 29, 20232 min read
ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products
On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...
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Sharan Murugan
Apr 29, 20231 min read
EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure
Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...
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Sharan Murugan
Apr 29, 20232 min read
MHRA Guidance: Registration & Regulating Medical Devices in UK
Yesterday (28 April 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Regulating...
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Sharan Murugan
Apr 23, 20231 min read
Health Canada: Guidance on Nitrosamine Impurities in Medications
Health Canada last week published an updated "Guidance on Nitrosamine Impurities in Medications" that details about on Evaluating and...
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Sharan Murugan
Apr 23, 20231 min read
USFDA Guidance: Animal Rule Developing Drugs for Prevention & Treatment "Acute Radiation Syndrome"
Last week (19 April, 2023) the United States Food & Drug Administration released a new draft guidance on "Acute Radiation Syndrome:...
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Sharan Murugan
Apr 23, 20231 min read
EMA Guidance: IRIS guide to Registration and Research Product Identifiers
Last Week (20 April 2023) the European Medicines Agency updated and released the guidance on "IRIS guide to Registration and RPIs" which...
151 views0 comments
Sharan Murugan
Apr 18, 20231 min read
Malaysia NPRA: Guideline on Electronic Labelling (E-LABELLING) for Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (11 April, 2023) released an updated guideline on " Electronic...
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Sharan Murugan
Apr 17, 20231 min read
Swiss Medic: Information sheet on Clinical Investigations with Medical Devices
Recently (13-April-2023) Switzerland's Swissmedic released an updated Information sheet document for "Information sheet on Clinical...
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Sharan Murugan
Apr 17, 20232 min read
Ireland's HPRA: Guide to SAR /Event Reporting for Human Organs Intended for Transplantation
Earlier today (17-April-2023) he Health Products Regulatory Authority (HPRA) of Ireland updated its guidance on "Guide to Serious Adverse...
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Sharan Murugan
Apr 16, 20232 min read
IMDRF Guidance: CyberSecurity, Post-Market Surveillance, Personalized Medical Devices
Recently (IMDRF) released new four technical guidelines, "Personalized Medical Devices – Production Verification and Validation",...
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Sharan Murugan
Apr 12, 20231 min read
USFDA Guidance: Transdermal and Topical Delivery Systems for ANDAs
Today (12 April 2023) USFDA's Center for Drug Evaluation and Research released two draft guidances on"Assessing Adhesion With Transdermal...
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Sharan Murugan
Apr 12, 20231 min read
USFDA Guidance: Format and Content for OTC Monograph Order Requests
Earlier today (12 April 2023) USFDA's Center for Drug Evaluation and Research released a draft guidance on"Over-the-Counter Monograph...
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Sharan Murugan
Apr 11, 20231 min read
USFDA Q&A: A Risk-Based Approach to Monitoring of Clinical Investigations
Earlier today (11th April 2023) USFDA released final guidance on"A Risk-Based Approach to Monitoring of Clinical Investigations Questions...
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Sharan Murugan
Apr 9, 20231 min read
UK MHRA: Guidance on Good Clinical Practice for Clinical Trials
The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...
174 views0 comments
Sharan Murugan
Apr 5, 20231 min read
USFDA Guidance: Clinical Outcome Assessments Into Endpoints for Regulatory Decision
Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...
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Sharan Murugan
Apr 5, 20232 min read
USFDA Guidance: Permanent Discontinuance or Interruption in Manufacturing of Finished Products &API
Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...
63 views0 comments
Sharan Murugan
Apr 4, 20232 min read
UK MHRA: MHRA Fees 2023 & Guidance on How to Draft a Direct Health Care Professional Communication
Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...
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Sharan Murugan
Apr 2, 20231 min read
Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...
83 views0 comments