Regulatory Blog

The Regulatory News you Need to Know,Share & Grow

Malaysia's Medical Device Authority: Guideline on Medical Face Mask and Respirator

Recently (19 May, 2023) Medical Device Authority (MDA) of the Ministry of Health Malaysia released an updated guidance on "Medical Face...

Sharan Murugan

May 23, 20231 min read

Switzerland's Swissmedic: Med Dev Guidance on Export Certificates and Service Agreement

Yesterday (23 May 2023) Switzerland's Swissmedic released two updated guidances one is "Export Certificates" guidance and another one is...

Sharan Murugan

May 23, 20232 min read

South Africa's SAPHRA: Updated Medicines Application Form Module 1.2.1

Recently (18 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Application form template...

Sharan Murugan

May 21, 20231 min read

Saudi Arabia’s (SFDA): Requirements on Importation and Shipments of Medical Devices (MDS-REQ5)

Earlier today (21 May 2023) to ensure the importation and shipment of medical devices comply with rigorous standards, the Saudi Food and...

Sharan Murugan

May 21, 20231 min read

USFDA Guidance: Pediatric Drug Development - Regulatory and Scientific Considerations

The United States Food & Drug Administration released two draft guidelines today (18-May-2023) "Pediatric Drug Development: Regulatory...

Sharan Murugan

May 18, 20232 min read

EMA Guidance: Good Practices for Industry for the Prevention of Human Medicinal Product Shortages

Earlier today (17 May 2023) the European Medicines Agency released an updated guidance document on "Good Practices for Industry for the...

Sharan Murugan

May 18, 20231 min read

UK MHRA: Med Dev Guidance on "Off-Label Use","Virtual Mfg." "Legal Requirements" & "Approved Bodies"

UK's Medicines and Healthcare Products Regulatory Agency (MHRA) this week (16,17 May 2023) released updated multiple guidances related...

Sharan Murugan

May 18, 20232 min read

USFDA Guidance: Testing of Glycerin & High Risk Drug Components & CBER Guidances on Blood Products

This week (11 & 12 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for...

Sharan Murugan

May 13, 20231 min read

EC MDCG: Med Dev Guidance on Significant Changes regarding the Transitional Provision MDR

The European Commission’s Medical Device Coordination Group (MDCG) released updated guidance "Guidance on significant changes regarding...

Sharan Murugan

May 13, 20231 min read

UK MHRA: Guidance on Qualified Person responsible for QPPV & PSMF

Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated "Guidance on the qualified...

Sharan Murugan

May 13, 20232 min read

UK MHRA Guidance: Notifying MHRA on a Clinical Investigation for a Medical Device

Last Thursday (11 May 2023) UK's Medicines and Healthcare Products Regulatory Agency (MHRA) released updated Guidance on "Notify the MHRA...

Sharan Murugan

May 13, 20232 min read

South Africa's SAPHRA: Validation Template For ECTD Variation Applications, QOA & QIS

Recently (05 May 2023) the South African Health Products Regulatory Authority (SAPHRA) released the template "Validation Template For...

Sharan Murugan

May 9, 20231 min read

Swiss Medic: Guidance on Transfer of Marketing Authorisation

Swissmedic, the Swiss Agency for Therapeutic Products, published an updated guidance document on (3 May 2023) the "Transfer of Marketing...

Sharan Murugan

May 7, 20231 min read

USFDA Guidance: Assessing User Fees Under the PDUFA of 2022

This Monday (01 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

May 4, 20231 min read

ICH/USFDA Final Guidance: Q9(R1) Quality Risk Management

Yesterday (03 May, 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research and Center for Biologics...

Sharan Murugan

May 4, 20231 min read

Singapore's HSA: Consultation on eCTD Implementation & Risk Classification on IVD

On 2nd May, 2023 Singapore's Health Sciences Authority (HSA) invited the industry to participate in the consultation on eCTD submissions...

Sharan Murugan

May 4, 20231 min read

USFDA Guidance: Decentralized Clinical Trials for Drugs, Biological Products, and Devices

Today (02 May 2023) the United States Food & Drug Administration's Center for Drug Evaluation and Research, Center for Biologics...

Sharan Murugan

May 2, 20232 min read

South Africa: Information Guideline and Quality and Bioequivalence guidelines Aligning with EMA/ICH

Recently (24 April 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated "General Information...

Sharan Murugan

Apr 29, 20231 min read

ICH/ USFDA Guidance: S12 Nonclinical Biodistribution Considerations for Gene Therapy Products

On 27th April, 2023 the United States Food & Drug Administration Center for Drug Evaluation and Research, and Center for Biologics...

Sharan Murugan

Apr 29, 20232 min read

EMA Guidance: Pre & Post Authorisation for Users of the Centralised Procedure

Recently this week (25 April, 20223) the European Medicines Agency updated and released the guidances on "Pre-authorisation procedural...

Sharan Murugan

Apr 29, 20231 min read