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ICH M14 Guideline: General Principles on Plan, Design and Analysis of Pharmacoepidemiological Studies That Utilize Real-World Data for Safety Assessment of Medicines
Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...
Sharan Murugan
May 31, 20242 min read
33 views
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USFDA Guidance: Platform Technology Designation Program for Drug Development
Today (29 May 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
May 28, 20242 min read
68 views
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Malaysia NPRA: Electronic Labelling (E-Labelling) Guidance For Pharmaceutical Products
Malaysia's National Pharmaceutical Regulatory Agency (NPRA) last week (21 May, 2024) released an updated guideline on " Electronic...
Sharan Murugan
May 25, 20242 min read
110 views
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EDQM Guidance: Content of the Dossier for Sterile Substances
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has released a draft guideline titled "Content of the Dossier...
Sharan Murugan
May 25, 20242 min read
50 views
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Philippines FDA: Authorization for Registration Applications of Pharmaceutical Products and Active Pharmaceutical Ingredients for Human Use
The Philippines Food and Drug Administration (FDA) has released a draft (for comments) "Rules and regulations for the authorization and...
Sharan Murugan
May 18, 20241 min read
45 views
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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
63 views
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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
31 views
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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 18, 20242 min read
38 views
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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
52 views
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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
12 views
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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
125 views
0 comments
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
22 views
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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
22 views
0 comments
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
29 views
0 comments
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
11 views
0 comments
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
14 views
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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
257 views
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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
23 views
0 comments
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
192 views
0 comments
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
43 views
0 comments