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USFDA Guidance: Assessing User Fees -BsUFA III: Biosimilar User Fee Amendments of 2022

Today (31 July 2023) the United States Food & Drug Administration's Center for Biologics Evaluation and Research and Center for Drug...

Sharan Murugan

Aug 1, 20232 min read

Malaysia NPRA: Guidance on Drug Registration

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (26 July, 2023) released an updated guidance on "Drug Registration"...

Sharan Murugan

Jul 30, 20232 min read

Canada HC Guidance: Nitrosamine Impurities in Medications

Last Friday (28 July, 2023) Health Canada published an updated "Guidance on Nitrosamine Impurities in Medications" that details about...

Sharan Murugan

Jul 30, 20231 min read

USFDA Med Dev Guidance: On Opioid Use Disorder & Hydrogen Peroxide-Based Contact Lens Care Products

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use Disorder Last week (26 June, 2023) the United States Food &...

Sharan Murugan

Jul 30, 20232 min read

UK MHRA: Guidance on Renewing Marketing Authorisations & Implementation of Med Dev. Future Regime

Guidance on Renewing Marketing Authorisations Recently (28, July 2023) the UK's Medicines and Healthcare Products Regulatory Agency...

Sharan Murugan

Jul 30, 20231 min read

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

USFDA Guidance: Qualification of Medical Device Development Tools

Today (17 July 2023) the USFDA's Center for Devices and Radiological Health (CDRH) released final guidance on "Qualification of Medical...

Sharan Murugan

Jul 17, 20232 min read

MHRA Med Dev Guidance: In-Vitro Diagnostic Medical Devices on Legislation

Earlier today (17 July, 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "The...

Sharan Murugan

Jul 17, 20231 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

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

UK MHRA MD Guidance: Borderlines with Medical Devices & Other Products in Great Britain

Yesterday(01 July 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidelines on the "Borderlines...

Sharan Murugan

Jul 2, 20231 min read