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Guide to Reporting and Initial Investigation of Quality Defects-Ireland HPRA
On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of...
Sharan Murugan
Sep 2, 20212 min read
MHRA's New & updated Innovative Licensing and Access Pathway - UK
A new pathway supporting innovative approaches to the safe, timely, and efficient development of medicines to improve patient access was...
Sharan Murugan
Aug 31, 20211 min read
Draft Guidance on PK-Based Criteria for Alternative Dosing Regimens for Treatment of Cancer - USFDA
On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...
Sharan Murugan
Aug 30, 20211 min read
Malaysia release GUIDANCE on "FOREIGN GMP INSPECTION"- NPRA
Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices...
Sharan Murugan
Aug 25, 20211 min read
GCC Guidance on Labeling Information, SPC and PIL - Gulf Cooperation Council & SFDA
The Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling...
Sharan Murugan
Aug 23, 20211 min read
FDA Export Certification - Revised Guidance -US FDA
This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...
Sharan Murugan
Aug 21, 20211 min read
Revised Draft Guidance on Bioequivalence Studies for Generic Drugs – US FDA
On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...
Sharan Murugan
Aug 21, 20211 min read
Updated Prescription Medicines Registration Process – TGA Australia
Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical...
Sharan Murugan
Aug 19, 20212 min read
Request for Comments on pre-Hatch-Waxman ‘PANDA’ applications - FDA
On 12th August, 2021 the US Food and Drug Administration (FDA) announced the establishment of a public docket to solicit comments on...
Sharan Murugan
Aug 13, 20211 min read
Guidance’s on GMP for Investigational Products & for R&D facilities -WHO
World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...
Sharan Murugan
Aug 8, 20211 min read
Guidance on Development and Submission of Near Infrared Analytical Procedures– USFDA
US Food and Drug Administration (FDA) on 06-July-2021, finalized guidance on “Development and Submission of Near Infrared Analytical...
Sharan Murugan
Aug 8, 20211 min read
Guidance on Metastasis-Free Survival as an Endpoint - Prostate Cancer trials – USFDA
USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...
Sharan Murugan
Aug 8, 20211 min read
Guidance on Variations, Extensions, Doc Protections, Form & Criteria Annex – Swissmedic -HMV4
Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows 1. Guidance document Variations and extensions HMV4...
Sharan Murugan
Aug 6, 20212 min read
Guidance on Developing Drug Shortage Management Plans - France - ANSM
The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage...
Sharan Murugan
Aug 1, 20211 min read
Pre-Authorisation Procedural Advice for Users of the Centralised Procedure - EMA
This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...
Sharan Murugan
Jul 29, 20211 min read
Guideline on Quality Documentation for Drug-Device Combination Products - EMA
The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...
Sharan Murugan
Jul 29, 20211 min read
ICH Q13 Draft Guideline reaches Step 2 of the ICH process
ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...
Sharan Murugan
Jul 28, 20211 min read
FDA’s revised MAPP Procedures for Generic Drug Labeling Change
FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...
Sharan Murugan
Jul 28, 20211 min read
Guidance on Packaging for Human Medicinal Products, Med.Prod Names & eSubmissions platform - Swiss
Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...
Sharan Murugan
Jul 19, 20211 min read
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) – EMA
European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...
Sharan Murugan
Jul 13, 20211 min read