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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...
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Sharan Murugan
Apr 22, 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...
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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...
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Sharan Murugan
Apr 20, 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...
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Sharan Murugan
Apr 16, 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...
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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...
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Sharan Murugan
Apr 13, 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...
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Sharan Murugan
Apr 7, 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...
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Sharan Murugan
Apr 4, 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...
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Sharan Murugan
Mar 30, 20241 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...
97 views0 comments
Sharan Murugan
Mar 30, 20242 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...
31 views1 comment
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...
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Sharan Murugan
Mar 29, 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...
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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...
15 views0 comments
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"....
54 views0 comments
Sharan Murugan
Mar 27, 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...
27 views0 comments
Sharan Murugan
Mar 25, 20242 min read
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on...
57 views0 comments
Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
31 views0 comments
Sharan Murugan
Mar 20, 20242 min read
USFDA Guidance: Controlled Correspondence Related to Generic Drug Development
On 18th March, 2024 the U.S. Food and Drug Administration (FDA) the Center for Drug Evaluation and Research released the final guidance...
36 views0 comments
Sharan Murugan
Mar 20, 20242 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
24 views0 comments