Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

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 Established Medicines Marketing Authorisation Application Process Changes

The UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance "Established Medicines Marketing Authorisation...

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India CDSCO: Draft Guidance on Post Approval Changes (PAC’s) for Biologicals for consulataion

India's Central Drugs Standard Control Organization (CDSCO) has published draft guidance "Post Approval Changes in Biological Products:...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

USFDA Guidance: Q&A-Charging for Investigational Drugs Under an IND - What You Need to Know

Earlier this week (14 February, 2024) the the U.S. Food and Drug Administration (FDA) released guidance "Charging for Investigational...

Sharan Murugan

Feb 17, 20241 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

USFDA Guidance: Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products

FDA announced on Monday (29-January-2024) that a draft guidance for the industry is available titled, "Collection of Race and Ethnicity...

Sharan Murugan

Jan 31, 20241 min read

USFDA Guidance: Human Gene Therapy Products Incorporating Human Genome Editing & Development of Chimeric Antigen Receptor (CAR) T Cell Products

On Monday (29 January 2024) the U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation released two...

Sharan Murugan

Jan 31, 20242 min read

USFDA Guidance: Conducting Remote Regulatory Assessments Questions and Answers

Last Friday (26 January 2024), the FDA Office of Regulatory Affairs announced the availability of a revised draft guidance for the...

Sharan Murugan

Jan 28, 20242 min read