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Ireland HPRA: Guide to Renewal of Marketing Authorisations –Human Medicines
Irelands Health Products Regulatory Authority (HPRA) released guidance on "Guide to Renewal of Marketing Authorisations - Human...
Sharan Murugan
Mar 29, 20242 min read
Swiss Medic: eCTD Guidance for Industry & Time limits for Authorisation Applications
Swissmedic, recently published updated guidance on "Guidance Industry eCTD" and "Guidance on Time limits for Authorisation Applications"....
Sharan Murugan
Mar 29, 20242 min read
EMA Guidance: e-Submission of Information on IMP in the Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
The European Medicines Agency (EMA) last Wednesday released an updated guidance on the electronic submission of information on...
Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Regulation of devices in Northern Ireland & Apply for Manufacturer or Wholesaler of Medicines Licences
Earlier today (25 March 2025) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
Sharan Murugan
Mar 25, 20242 min read
UK MHRA: Guidance on Licence to Market, Export Drugs, Reclassifing Medicine s & Notifying about a Clinical Investigation for a Medical Device
This week the Medicines and Healthcare Products Regulatory Agency (MHRA) updated multiple guidelines related to medicine and medical...
Sharan Murugan
Mar 20, 20242 min read
ICH (Final) Guidance: Q2(R2) Validation of Analytical Procedures and Q14 Analytical Procedure Development
Last week the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research, Office of Regulatory Policy, and the...
Sharan Murugan
Mar 13, 20241 min read
UK MHRA: Guidance on Packaging, Labelling and Patient Information Leaflets
Earlier today (08 March 2024) Medicines and Healthcare Products Regulatory Agency (MHRA) updated its "Guidance on Medicines: Packaging,...
Sharan Murugan
Mar 7, 20242 min read
India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion
India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...
Sharan Murugan
Mar 5, 20242 min read
USFDA Guidance: Clinical Pharmacology Considerations for Antibody-Drug Conjugates
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Mar 5, 20242 min read
USFDA Guidance: Reporting Amount of Listed Drugs and Biological Product and Key Information and Facilitating Understanding in Informed Consent Guidance
Earlier this week (26 & 29 February 2024) the the U.S. Food and Drug Administration (FDA) released two guidances "Reporting Amount of...
Sharan Murugan
Mar 2, 20242 min read
EMA: QRD updation and Product-Information Templates Updation
The European Medicines Agency released an updated template on QRD and updated its page on "Product-information templates - Human". The...
Sharan Murugan
Mar 2, 20242 min read
UK MHRA Guidance: Navigating on Applying for a Licence to Market a Medicine
Last Wednesday (28 February 2024) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated guidance on "Apply for...
Sharan Murugan
Mar 2, 20242 min read
South Africe SAPHRA: Guidelines For Medicine Recalls – Withdrawals And Rapid Alerts
Recently last week the South African Health Products Regulatory Authority (SAPHRA) released an updated guideline "Guidelines For Medicine...
Sharan Murugan
Feb 22, 20242 min read
EMA Guidance: Electronic Submission of Information for Investigational Medicinal Products in XEVMPD
Recently (14 February 2024) the European Medicines Agency released updated (annotated) guidance on "Guidance on the electronic submission...
Sharan Murugan
Feb 17, 20242 min read
USFDA Guidance: Use of Data Monitoring Committees in Clinical Trials
Today (13 February 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research, Center for Devices...
Sharan Murugan
Feb 13, 20242 min read
USFDA CMC Guidance: Advanced Manufacturing Technologies Designation Program
The U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research...
Sharan Murugan
Feb 13, 20242 min read
Swissmedic Guidance: Navigating Variations, Product Information, and Electronic ICSRs through PV Gateway
Yesterday (06 February 2024) Switzerland's Swissmedic released updated guidance on "Electronic exchange of ICSRs through PV Gateway", and...
Sharan Murugan
Feb 7, 20242 min read
USFDA Guidance: "Understanding the USFDA Notification Process for Discontinuance or Interruption in Manufacturing of Pharmaceutical Products"
Yesterday (06 February 2024) the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research and Center for Biologics...
Sharan Murugan
Feb 7, 20242 min read
Saudi's SFDA: Good Manufacturing Practice for Blood Establishments
Blood establishments play a crucial role in ensuring a safe and adequate supply of blood for transfusion and other medical purposes. To...
Sharan Murugan
Feb 7, 20242 min read
Australia TGA: eCTD AU module 1 and regional information
Australia's Therapeutic Goods Administration (TGA) released updated guidance "eCTD AU module 1 and regional information" on 30 January...
Sharan Murugan
Jan 31, 20241 min read