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Swissmedic Guidance: Import of a Human Medicinal Product (Parallel Import)

Today (01 May 2024) Switzerland's Swissmedic released updated guidance on "Import of a Human Medicinal Product according to Art. 14 para....

Sharan Murugan

May 1, 20242 min read

USFDA Guidance: Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling

Today (29 April 2024), FDA released a new draft guidance for the industry titled "Content and Format of Composition Statement and...

Sharan Murugan

Apr 27, 20242 min read

USFDA Guidance: Cancer Clinical Trial Eligibility Criterias

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence, Center for Drug Evaluation and Research, and Center for...

Sharan Murugan

Apr 27, 20242 min read

USFDA Guidance: Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products Q&A

On 24 April 2026 (Wednesday) the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research released a...

Sharan Murugan

Apr 27, 20242 min read

EMA: Guidance on the Anonymisation of PPD & Assessment of CCI during the preparation of RMPs

The European Medicines Agency (EMA) yesterday (26 April, 2024) released an updated guidance on the "Anonymisation of protected personal...

Sharan Murugan

Apr 27, 20242 min read

Swiss Medic: Guidance on GMP compliance by Foreign Manufacturers & Application Establishment Licence for Medicinal Products

This Monday (24 April 2024) Swissmedic, updated its guidance on "GMP compliance by Foreign Manufacturers" and "Application establishment...

Sharan Murugan

Apr 22, 20242 min read

UK MHRA Guidance: Applying for a Variation to a Marketing Authorisation

Yesterday (22 April 2024) the UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Medicines: apply for a...

Sharan Murugan

Apr 22, 20242 min read

WHO Guidance: GMP in Preventing and Controlling Nitrosamine Contamination in Pharmaceuticals

Earlier this week, the World Health Organization (WHO) released draft guidelines "WHO Good Manufacturing Practices Considerations for the...

Sharan Murugan

Apr 20, 20242 min read

EMA Guidance: Real-World Evidence for supporting Regulatory Decision-Making

On 12 April 2024 the European Medicines Agency released "Guidance on real-world evidence provided by EMA: support for regulatory...

Sharan Murugan

Apr 16, 20242 min read

UK MHRA: Rolling Review for MAA and 150-Day Assessment for National Applications

Earlier today (16 April 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance on "Rolling Review for...

Sharan Murugan

Apr 16, 20242 min read

EMA: Guidance on the Pharmaceutical Quality of Inhalation & Nasal Medicinal Products

Yesterday (12 April 2024) the European Medicines Agency released new guidance on "The Pharmaceutical Quality of Inhalation & Nasal...

Sharan Murugan

Apr 13, 20242 min read

Ireland HPRA: Submitting a Request for Ireland to Act as RMS in a Decentralised Procedure

Irelands Health Products Regulatory Authority (HPRA) released updated guidance on "Submitting a Request for Ireland to Act as RMS in a...

Sharan Murugan

Apr 7, 20242 min read

USFDA: Guidance one eSubmission of Expedited Safety Reports From IND-Exempt BA/BE Studies and Data Integrity for In Vivo BA & BE studies

Today (04 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research released draft guidance on...

Sharan Murugan

Apr 4, 20242 min read

Australia TGA: Clinical Trial Notification (CTN) Form - User Guide

On 28th March, 2024 Australia's Therapeutic Goods Administration (TGA) released an updated guidance on the "Clinical Trial Notification...

Sharan Murugan

Mar 30, 20241 min read

USFDA Guidance: Regional Implementation Guide for E2B (R3) e-Transmission of ICSR and Providing Regulatory Submissions in Electronic Format: IND Safety Reports

Today (01 April 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

Mar 30, 20242 min read

South Africa SAPHRA: Guideline For Professional Information For Human Medicines (Categories A and D) and Classification of Medical Devices and IVDs

Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated "Guideline For Professional...

Sharan Murugan

Mar 30, 20242 min read

Malaysian Guideline for Application of Clinical Trial Import Licence (CTIL) & Clinical Trial Exemption (CTX)

Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released an updated guideline on "Guideline for Application of Clinical Trial...

Sharan Murugan

Mar 29, 20242 min read

Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines

Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human...

Sharan Murugan

Mar 29, 20242 min read

Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications

Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....

Sharan Murugan

Mar 29, 20242 min read

USFDA Guidance: Handling and Retention of Bioavailability (BA) & Bioequivalence (BE) Testing Samples

The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research updated and released the draft guidance "Handling and...

Sharan Murugan

Mar 27, 20242 min read