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Jun 6, 20231 min read

USFDA/ICH - E6(R3) GCP Guideline: Modernizing the Design & Conduct of Clinical Trials

The US Food and Drug Administration has announced earlier today (06 June, 2023) the availability of a draft guidance "E6(R3) Good...

Jun 6, 20231 min read

South Africa's (SAPHRA): Guideline on Pharmacovigilance Systems

Earlier today (06 June, 2023) the South African Health Products Regulatory Authority (SAPHRA) released an updated Guideline on...

Jun 5, 20231 min read

USFDA Guidance: Cover Letter Attachments for Controlled Correspondences & ANDA Submissions

The United States Food & Drug Administration published the final guidance "Cover Letter Attachments for Controlled Correspondences and...

Jun 4, 20231 min read

Australia's TGA: Guidance on Regulation of Software based Medical Devices

Recently on 2nd June, 2023 Australia's Therapeutic Goods Administration (TGA) released guidance on the "Regulation of Software based...

Jun 4, 20232 min read

SwissMedic Guidance: Orphan Drug, New Active Substance & Prior Notification

Swissmedic recently (02 June 2023) released multiple important guidelines that have captivated the audience and generated significant...

Jun 4, 20231 min read

SwissMedic Guidance on Fast-Track Authorisation, Temporary Authorisation and Variations & Extensions

Last week Swissmedic, the Swiss Agency for Therapeutic Products updated and released 3 Important guidances and forms. 1. Guidance on...

Jun 4, 20232 min read

USFDA Guidance: Drug-Drug Interaction Assessment & Nonclinical Evaluation of Immunotoxicity

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

Jun 4, 20231 min read

USFDA Guidance: Medical Device Submissions "The Q-Submission Program"

Last Friday (02 June 2023) the United States Food & Drug Administration's Center for Devices and Radiological Health and Center for...