Search
UK MHRA Guidance: Pre-submission Advice & Support
UK's Medicines and Healthcare products Regulatory Agency (MHRA) updated and released ( 1 October 2024 ) guidance " Pre-Submission Advice...
Sharan Murugan
Oct 2, 20242 min read
UK MHRA: Guidance on Applying for a Manufacturer or Wholesaler of Medicines Licence
Yesterday (27 September 2024) the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on " Applying...
Sharan Murugan
Sep 28, 20242 min read
India CDSCO Guidance: Pharmacovigilance Document for Marketing Authorization Holders of Pharmaceutical Products
India's CDSCO Pharmacovigilance released an updated guidance " Pharmacovigilance Guidance Document for Marketing Authorization Holders of...
Sharan Murugan
Sep 25, 20242 min read
USFDA Guidance: An Acceptable Circular of Information for the Use of Human Blood and Blood Components
The USFDA's Center for Biologics Evaluation and Research (CBER) has released the final guidance document , titled “ An Acceptable...
Sharan Murugan
Sep 25, 20242 min read
USFDA Med Dev Guidance: Biocompatibility Testing and Accreditation Scheme for Conformity Assessment (ASCA) Program
USFDAs Center for Devices and Radiological Health and Center for Biologics Evaluation and Research released multiple draft guidance...
Sharan Murugan
Sep 22, 20242 min read
SFDA Guidance: Conducting Clinical Trials with Decentralized Elements & Integrating Randomized Controlled Trials
Guidance: Conducting Clinical Trials With Decentralized Elements The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation...
Sharan Murugan
Sep 22, 20242 min read
EMA IRIS Guide for Applicants: How to Create, Submit, and Manage IRIS Applications
On 16 September 2024 the European Medicines Agency (EMA) provided a detailed guide " IRIS guide for applicants - How to create and submit...
Sharan Murugan
Sep 21, 20242 min read
USFDA Guidance: Providing Regulatory Submissions in Electronic Format Using eCTD Specifications
This Friday (13 Septmeber, 2024) the USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Sep 15, 20242 min read
EMA: Harnessing AI in Medicines Regulation: The Role of Large Language Models (LLMs)
The advancement of Artificial Intelligence (AI) is transforming many industries, and the pharmaceutical and regulatory sectors are no...
Sharan Murugan
Sep 15, 20242 min read
UK MHRA: Windsor Framework: Wholesalers & Manufacturers Guidance & Labelling and Packaging Requirements
The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has released 2 updated essential guidances " Wholesalers &...
Sharan Murugan
Sep 15, 20242 min read
South Africa SAHPRA: eCTD Validation and Technical Screening for Renewals - Template
The South African Health Products Regulatory Authority (SAHPRA) has provided updated guidance for " ECTD Validation And Technical...
Sharan Murugan
Sep 9, 20242 min read
USFDA Guidance: Incorporating Voluntary Patient Preference Information Over the Total Product Life Cycle
USFDA's Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) released a draft...
Sharan Murugan
Sep 6, 20242 min read
USFDA Guidance: Bioresearch Monitoring Technical Conformance Guide
The USFDA Center for Drug Evaluation and Research issued the final guidance today (03 September 2024) " Bioresearch Monitoring...
Sharan Murugan
Sep 3, 20242 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format through PV Gateway
The Swissmedic released an updated guidance " Electronic Exchange of ICSRs in E2B(R2) Format through PV Gateway " that provides...
Sharan Murugan
Aug 31, 20242 min read
USFDA Guidance: Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers
The U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research and Center for Devices and Radiological Health ...
Sharan Murugan
Aug 31, 20242 min read
India's: Newly Launched Indian Pharmacopoeia (IP) Online Portal and Adverse Drug Monitoring System (ADRMS) Online Portal
India has recently made significant advancements in its healthcare regulatory landscape by launching two new online portals " Adverse...
Sharan Murugan
Aug 27, 20242 min read
UK MHRA Guidance: Clinical Trials for Medicines – Applying for Authorisation in the UK
The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated their comprehensive guidance " Clinical Trials for Medicines –...
Sharan Murugan
Aug 27, 20242 min read
Swissmedic Guidance: The Electronic Exchange of ICSRs in E2B(R3) Format Through B2B Gateway
Today (26 August, 2024) the Swissmedic released " guidance for the industry on the electronic exchange of ICSRs in E2B(R3) format...
Sharan Murugan
Aug 26, 20242 min read
India CDSCO Guidance: Draft Pharmaceutical Good Distribution Practices (GDP)
The Central Drugs Standard Control Organisation (CDSCO) in India has issued a draft guideline on Good Distribution Practices (GDP) for...
Sharan Murugan
Aug 20, 20242 min read
USFDA Guidance: Product-Specific Guidance Meetings Between FDA and ANDA Applicants Under GDUFA
The U.S. Food and Drug Administration (FDA) on August 19, 2024, published the guidance “ Product-Specific Guidance Meetings Between FDA...
Sharan Murugan
Aug 19, 20242 min read