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Sharan Murugan
Sep 23, 20211 min read
Swissmedic- Updated Guidance on Authorisation of Human Med.Product with New Active Substance
On 17.09.2021, swiss medic released an updated Guidance on Authorisation of Human Medicinal Product with New Active Substance HMV4. The...
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Sharan Murugan
Sep 17, 20211 min read
South Africa- Updated Guideline on Classification of Med.Dev and IVDs & Medicines for use in PHU
Updated Guideline on Classification Of Medical Devices and IVDs The aim of this guideline is to assist manufacturers, importers,...
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Sharan Murugan
Sep 17, 20211 min read
Denmark- Updated Guidance on Implementation Of Decentralised Elements In Clinical Trials
Decentralized clinical trials cover a multitude of elements that reduce, or in some cases even eliminate, the need for the trial...
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Sharan Murugan
Sep 14, 20212 min read
USFDA’s Study Data Technical Conformance Guide & Technical Specifications Doc Update -USA
Study Data Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit standardized...
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Sharan Murugan
Sep 11, 20211 min read
USFDA's updated guidance on Development of ANDA During the COVID-19 Pandemic – Q&A -USA
On 8th September 2021, FDA issued this guidance to provide general recommendations to prospective applicants and applicants of...
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Sharan Murugan
Sep 11, 20211 min read
UK’s Updated Guidance on Managing Clinical Trials due to COVID-19 & Access to eHealth Records -MHRA
Managing clinical trials during Coronavirus (COVID-19) On 8th September 2021, MHRA updated the guidance on How investigators and sponsors...
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Sharan Murugan
Sep 8, 20211 min read
USFDA's Novel Excipient Review Pilot Program
The Center for Drug Evaluation and Research (CDER) has launched the voluntary Novel Excipient Review Pilot Program (Pilot Program), which...
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Sharan Murugan
Sep 8, 20212 min read
Malaysia-NPRA Releases Guidelines on Good PharmacoVigilance (GPv) Practices
The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has released guidance about the requirements and procedures of good...
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Sharan Murugan
Sep 7, 20211 min read
Swissmedic Updates Forms for New Authorization, Variations & Extensions-Switzerland
On 01.09.2021, Swissmedic updated the forms for New authorisation of human medicinal products HMV4 and Variations and authorisation...
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Sharan Murugan
Sep 5, 20211 min read
Updated Guidance for e-Submissions for CEP applications
As the eCTD format is mandatory for the submission of all applications for Certificates of Suitability to the monographs of the European...
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Sharan Murugan
Sep 2, 20212 min read
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...
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Sharan Murugan
Aug 31, 20211 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...
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Sharan Murugan
Aug 30, 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...
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Sharan Murugan
Aug 25, 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...
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Sharan Murugan
Aug 23, 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...
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Sharan Murugan
Aug 21, 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...
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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...
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Sharan Murugan
Aug 19, 20212 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...
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Sharan Murugan
Aug 13, 20211 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...
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Sharan Murugan
Aug 8, 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...
54 views0 comments