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South Africa (SAPHRA): Reliance Guideline
Recently this week the South African Health Products Regulatory Authority (SAHPRA) has updated the Reliance Guideline to streamline the...
Sharan Murugan
May 18, 20242 min read
Switzerland’s Swissmedic: Guidance on Temporary Authorization to Use an Unauthorised Medicinal Product
Swissmedic, the Swiss Agency for Therapeutic Products, has provided guidelines on (15 May 2024) "Temporary Authorization to Use an...
Sharan Murugan
May 18, 20242 min read
EMA Guidance: EudraVigilance Registration Documents
The European Medicines Agency (EMA) on Thursday (16 May, 2024) released an updated guidance on "EudraVigilance Registration Documents"...
Sharan Murugan
May 17, 20242 min read
Health Canada: Guidance on Preparation of Regulatory Activities in Non-eCTD Format & Filing submissions electronically
Health Canada recently (13 May 2024) updated its guidance "Preparation of Regulatory Activities in Non-eCTD Format" (electronic Common...
Sharan Murugan
May 14, 20242 min read
USFDA Guidance: REMS Logic Model: A Framework to Link Program Design With Assessment
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
May 11, 20242 min read
UK MHRA: Guidance on Send and Receive information on Adverse Drug Reactions (ADRs)
The UK Medicines and Healthcare Products Regulatory Agency (MHRA) updated its guidance "Send and Receive information on Adverse Drug...
Sharan Murugan
May 11, 20242 min read
Switzerland's SwissMedic: Guidance for requesting Product Certificates (CPP)
On 3rd May 2024 Switzerland's Swissmedic released an updated guidance document "For requesting Product Certificates (CPP)" that guides in...
Sharan Murugan
May 6, 20242 min read
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: Considerations for the Use of Human-and Animal-Derived Materials & Recognition and Use of a Standard for Uniform Blood & Blood Component Container Labels
Yesterday (30 April 2024), the FDA released a draft guidance for the industry titled "Considerations for the Use of Human-and...
Sharan Murugan
May 1, 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
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
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
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