Regulatory Blog

The Medicines and Healthcare Products Regulatory Agency (MHRA) recently (06 April 2023) released updated guidance on "Good Clinical...

Earlier today (o5 April 2023) USFDA's Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center...

Today (o5 April 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released a draft...

Statutory guidance on MHRA fees A new statutory fee for MHRA services was introduced on April 1, 2023, by the Medicines and Healthcare...

Recently Japan's the Ministry of Health, Welfare and Labour (MHLW) - Pharmaceuticals and Medical Devices Agency issued guidance “System...

Today (31 March 2023) USFDA's Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research released updated...

Earlier today (30 March 2023) USFDA released draft guidance on "Marketing Submission Recommendations for a Predetermined Change Control...

Pakistan's Drug Regulatory Authority of Pakistan released Draft Guidelines for "Good Cold Chain Management Practices for...

Starting from March 27, 2023, the FDA generic drug program will resume in-person face-to-face (FTF) meetings with the industry along with...

Earlier today (24 March 2023) USFDA's Oncology Center of Excellence released a draft guidance on "Clinical Trial Considerations to...

Earlier today Switzerlands Swissmedic released an updated guidance document for "Requesting Product Certificates - Certificate of a...

Earlier today (17 March 2023) Switzerland's SwissMedic released published the "Implementation Guide for eCTD v4.0" and the implementation...

Earlier today (16 March 2023) the US Food and Drug Administration's Center for Drug Evaluation and Research (CDER), Center for Biologics...

A draft guidance from the US Food and Drug Administration entitled "Electronic Systems, Electronic Records, and Electronic Signatures in...

Earlier today (13 March 2023) Switzerland's SwissMedic released an updated "Guidance document for requesting product certificates (CPP)"...

Yesterday (10 March 2023) released an updated word template that shall declare their worldwide registration status (WWRS) for all new...

Recently (9 March 2023) the European Medicine agency released a "Guideline on Computerised Systems & Electronic Data in Clinical Trials"...

Yesterday (3rd March 2023) the Philippines Food and Drug Administration (FDA) released an updated guideline "Guidelines on Regulatory...

Recently (01 march, 2023) Swissmedic released an updated guidance document on "Product information for human medicinal products" and...

Earlier today (01 March, 2023) USFDA released a draft guidance on "Potency Assay Considerations for Monoclonal Antibodies and Other...