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Finland adopts New Act on Clinical Trials Legislation (FIMEA)
The Parliament of Finland has adopted a new Act on Clinical Trials on 8 October 2021. The Parliament also approved amendments to the...
Sharan Murugan
Nov 7, 20211 min read
Saudi Arabia’s (SFDA) Guide on Regulatory Framework for Drug Registration, Variation or Renewals
Saudi Arabia’s (SFDA) updated Guide on Regulatory Framework for Drug Registration, Variation or Renewal The Drug Sector in Saudi Food &...
Sharan Murugan
Oct 19, 20211 min read
South Africa’s (SAHPRA’s) updated Reliance Guideline for a New Registration or Variation Application
This guideline is intended to provide information and guidance to applicants/HCRs on the prescribed requirements and process to be...
Sharan Murugan
Oct 19, 20211 min read
UK-MHRA Guidance on Pharmacovigilance Procedures
This guidance summarises UK-MHRA’s approach to pharmacovigilance. The Guidance on pharmacovigilance procedures was Updated on 14 October...
Sharan Murugan
Oct 19, 20211 min read
ICH guideline Recommendation on Daily (PDE) Limits for Seven Mutagenic Impurities
The International Council for Harmonization (ICH) Endorsed on 6 October 2021 its (Addendum to M7(R2)) M7(R2) draft guideline setting new...
Sharan Murugan
Oct 12, 20211 min read
European Commission (EC) updated guide on Good Lay Summary Practice
The European Commission (EC) on 04-October-2021 has put out recommendations on finest practices for preparation, translation and...
Sharan Murugan
Oct 7, 20211 min read
USFDA’s drafts “Investigator Responsibilities–Safety Reporting for Investigational Drugs & Devices
The U.S. Food and Drug Administration has released draft guidance for clinical trial investigators outlining their safety reporting...
Sharan Murugan
Oct 3, 20211 min read
USFDA’s drafts “Benefit-Risk Assessment for New Drug and Biological Products” Guidance
The intent of this guidance is to clarify for drug sponsors and other stakeholders how considerations about a drug’s benefits, risks, and...
Sharan Murugan
Oct 3, 20211 min read
USFDA’s Real-World Data: Assessing e-Health Records & Med Claims Data To Support Regulatory Decision
On 28-September, 2021 USFDA released the guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data To...
Sharan Murugan
Sep 29, 20212 min read
USFDA’s Q&A Quality (CMC) Related Controlled Correspondence for Generic Drugs
On 20.09.2021, USFDA released an updated Questions and Answers on Quality-Related Controlled Correspondence Guidance for Industry. This...
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...
Sharan Murugan
Sep 23, 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,...
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...
Sharan Murugan
Sep 17, 20211 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...
Sharan Murugan
Sep 14, 20212 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...
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...
Sharan Murugan
Sep 11, 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...
Sharan Murugan
Sep 8, 20211 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...
Sharan Murugan
Sep 8, 20212 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...
Sharan Murugan
Sep 7, 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...
Sharan Murugan
Sep 5, 20211 min read