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USFDA Guidance: BIMO Inspections Processes, Practices & Standardized Format for Electronic Submission
The US Food and Drug Administration (USFDA) is announcing the availability of a draft guidance for the industry entitled “Processes and...
Sharan Murugan
Jun 9, 20242 min read
India CDSCO: Guidance for Industry on Pharmacovigilance Requirements for Human Vaccines
The Central Drugs Standard Control Organisation (CDSCO) has issued comprehensive guidance on (29 May, 2024) "Guidance for Industry on...
Sharan Murugan
Jun 5, 20242 min read
EMA Guidance: Procedural Advice on Paediatric Applications
The European Medicines Agency (EMA) yesterday(04 June 2024) updated and released the guidance document "Procedural Advice on Paediatric...
Sharan Murugan
Jun 5, 20242 min read
EMA Guidance: IRIS Guide for Applicants
On 03-June-2024 the European Medicines Agency released an updated "IRIS Guide for Applicants" that guides How to create, submit and...
Sharan Murugan
Jun 5, 20242 min read
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Recently the International Council for Harmonisation (ICH) announced on 24 May, 2024 the availability of draft guidance for the industry...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
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
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
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
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
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: 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