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UK MHRA: Guidance on Labelling & Packaging of Medicinal Products - Windsor Framework

On 27 July 2023 UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Labelling and packaging of...

Sharan Murugan

Jul 30, 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...

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...

Sharan Murugan

Jul 24, 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"...

Sharan Murugan

Jul 21, 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...

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...

Sharan Murugan

Jul 15, 20232 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...

Sharan Murugan

Jul 15, 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...

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...

Sharan Murugan

Jul 12, 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...

Sharan Murugan

Jul 8, 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...

Sharan Murugan

Jul 4, 20231 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...

Sharan Murugan

Jul 4, 20232 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)...

Sharan Murugan

Jul 3, 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...

Sharan Murugan

Jul 2, 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...

Sharan Murugan

Jul 1, 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...

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...

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...

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...

Sharan Murugan

Jun 27, 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...

Sharan Murugan

Jun 25, 20231 min read