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Sharan Murugan
Jul 24, 20232 min read
USFDA Guidance: ICH M7(R2) Assessment and Control of DNA Reactive (Mutagenic) Impurities
Earlier today (25 June, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
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Sharan Murugan
Jul 24, 20232 min read
EC Guidance: Transition from Clinical Trials Directive to the Clinical Trials Regulation
The European Commission (EC) has long recognized the importance of streamlining and harmonizing the regulation of clinical trials across...
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Sharan Murugan
Jul 21, 20232 min read
Switzerland's SwissMedic: Harmonisation of the SwissGMP/GDP Inspection System
Yesterday (20 July 2023) Switzerland's Swissmedic released an updated guidance on "Harmonisation of the SwissGMP/GDP Inspection System"...
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Sharan Murugan
Jul 15, 20232 min read
Ireland HPRA: Guidance on Parallel Imports of Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Parallel Imports of Human Medicines" last week (12...
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Sharan Murugan
Jul 15, 20232 min read
USFDA Guidance: Manufacturing Changes & Comparability for CGT Products, Good Cause for Noncompliance
Last Week (13th & 14th July 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, and Center for...
29 views0 comments
Sharan Murugan
Jul 15, 20231 min read
EMA Guidance: Compilation of Union Procedures on Inspections & Exchange of Information
Yesterday (14 July 2023) the European Medicines Agency released an updated regulatory and procedural guideline "Compilation of Union...
328 views0 comments
Sharan Murugan
Jul 12, 20231 min read
USFDA Guidance: Considerations for Optimizing & Standardizing Diet in Clinical Trials (IEM)
Yesterday (11 July, 2023) the USFDA's Center for Drug Evaluation and Research (CDER) released updated guidance on "Inborn Errors of...
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Sharan Murugan
Jul 12, 20231 min read
Malaysia’s NPRA: Guideline on Manufacturer’s, Import, Wholesaler’s Licenses & Nitrosamine Impurity
Today (12 July, 2023) the National Pharmaceutical Regulatory Agency (NPRA) of Malaysia published a guideline on "Application of...
113 views0 comments
Sharan Murugan
Jul 8, 20231 min read
Switzerland's SwissMedic: Guidance on Medicinal Product Name
Yesterday (07 July 2023) Switzerland's Swissmedic released an updated guidance on "Medicinal Product Name" that describes the...
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Sharan Murugan
Jul 4, 20231 min read
Pakistan's DRAP: Guidelines for Post-Registration Variation of Drugs
Earlier today (04 July, 2023), the Drug Regulatory Authority of Pakistan released an updated draft guidance on "Guidelines for...
141 views0 comments
Sharan Murugan
Jul 4, 20232 min read
EMA Guideline: Notification of Serious Breaches or the Cinical Trial Protocol
Today (04 July 2023) the European Medicines Agency released a scientific guideline "Guideline for the notification of serious breaches of...
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Sharan Murugan
Jul 3, 20231 min read
EMA Guidance: Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
Earlier today (03 July 2023) the European Medicines Agency released updated guidance on "Guidance on Parallel EMA/HTA body (HTAb)...
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Sharan Murugan
Jul 2, 20231 min read
Health Canada: Guidance on Master Files Procedures & Administrative Requirements
Health Canada recently (26 June, 2023) published an updated guidance on "Guidance on Procedures and Administrative Requirements for...
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Sharan Murugan
Jul 1, 20231 min read
Singapore's HSA: Regulatory Updates for Therapeutic Product Registration
On 30th June 2023, Singapore's Health Sciences Authority (HSA) released updated guidance on "Regulatory Updates for Therapeutic Product...
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Sharan Murugan
Jun 27, 20231 min read
Philippines FDA: Publishing of Package Insert & PIL of Registered Drug Product in Verification Port
Recently (23 June, 2023) the Philippines Food and Drug Administration (FDA) released an updated draft guideline for comments "Guidelines...
128 views0 comments
Sharan Murugan
Jun 27, 20231 min read
EMA Guidance: Procedural Advice on Publication on Withdrawals of Applications related to MA
Today (27 June 2023), the European Medicines Agency released updated guidance on "Procedural Advice on Publication of Information on...
271 views0 comments
Sharan Murugan
Jun 27, 20231 min read
UK MHRA Guidance: Clinical Trials for Medicines: Apply for Authorisation in the UK
Yesterday (27 June 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Clinical Trials...
43 views0 comments
Sharan Murugan
Jun 27, 20231 min read
USFDA Guidance: Risk & Efficacy Information in Direct-to Consumer Prescription Drug Promo Labeling
A final guidance for the industry was issued today (27 June, 2023) by the US Food and Drug Administration titled "Presenting Quantitative...
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Sharan Murugan
Jun 25, 20231 min read
Switzerland's SwissMedic: Guidance on Information of PSURs/PBRER submission
On 21 June 2023, Switzerland's Swissmedic released an updated guidance on "Information of PSURs/PBRER Submission" which describes the...
100 views0 comments
Sharan Murugan
Jun 25, 20231 min read
USFDA Guidance: Psychedelic Drugs-Considerations for Clinical Investigations
Recently last week Friday (23 June 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research released...
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