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Japan's PMDA: Reporting ADR & Defects during Clinical Trials using e-Application Data System
Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...
Sharan Murugan
Apr 2, 20231 min read
USFDA Guidance: Identification of Medicinal Products — Implementation and Use
Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...
Sharan Murugan
Mar 31, 20231 min read
USFDA Med Dev: Marketing Submission Recommendations for Change Control Plan for AI/ML Enabled Device
Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...
Sharan Murugan
Mar 30, 20231 min read
Pakistan's DRAP: Guidelines for Good Cold Chain Management Practices
Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for...
Sharan Murugan
Mar 28, 20231 min read
USFDA Update: In-Person, Face-to-Face ANDA Program Meetings
Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...
Sharan Murugan
Mar 28, 20231 min read
USFDA Guidance: Clinical Trial Considerations to Support Accelerated Approval of Oncology Products
Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...
Sharan Murugan
Mar 24, 20231 min read
Swissmedic: Guidance for Requesting Product Certificates (Certificate of a Pharmaceutical Product)
Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...
Sharan Murugan
Mar 20, 20231 min read
Swissmedic: eCTD v4.0 Implementation Guide published
Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...
Sharan Murugan
Mar 17, 20231 min read
USFDA Guidance: Pharmacogenomic Data Submissions
Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics...
Sharan Murugan
Mar 17, 20231 min read
USFDA Guidance: Electronic Systems, e-Records, & e-Signatures in clinical Investigations: Q&A
A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...
Sharan Murugan
Mar 16, 20231 min read
Swissmedic Guidance: Requesting Certificate of a Pharmaceutical Product (CPP)
Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...
Sharan Murugan
Mar 13, 20231 min read
Malaysia NPRA: Declaration of WorldWide Registration Status for Generic Medicines in QUEST System
Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...
Sharan Murugan
Mar 11, 20231 min read
EMA Guideline: Computerised Systems & Electronic Data in Clinical Trials
Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...
Sharan Murugan
Mar 11, 20231 min read
Philippines FDA: Guidelines on Regulatory Reliance on the Conduct of Clinical Trials
Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...
Sharan Murugan
Mar 4, 20231 min read
Swiss Medic Guidance: Product Information & Packaging for Human Medicinal Products
Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...
Sharan Murugan
Mar 4, 20231 min read
USFDA Guidance: CMC-Potency Assay Considerations for Monoclonal Antibodies & Therap. Protiens
Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...
Sharan Murugan
Mar 1, 20231 min read
ICH-Quality Guidance: Q13 Continuous Manufacturing of Drug Substances and Drug Products
In today's FDA press release, the ICH final guidance titled "Q13 Continuous Manufacturing of Drug Substances and Drug Products" was...
Sharan Murugan
Mar 1, 20231 min read
EMA Procedural Advice: Recommendations on Unforeseen Variations
Earlier today (27 February 2023) European Medicine agency released an updated "Procedural Advice on Recommendations on unforeseen...
Sharan Murugan
Feb 27, 20231 min read
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants
The Food and Drug Administration published a new draft guidance for the industry on February 17, 2023, titled "Product-Specific Guidance...
Sharan Murugan
Feb 19, 20232 min read
Swiss Medic Guidance: Document on Formal requirements
Swissmedic released an updated guidance document on "Formal requirements" yesterday (15 February 2023). By publishing this document,...
Sharan Murugan
Feb 16, 20231 min read