Regulatory Blog

Earlier today (27-September-2022) EMA released draft guidance on the "Good Practice Guide for the use of the Metadata Catalogue of...

Earlier today (27 September 2022) MHRA released updated guidance on Good clinical practice for Clinical Trials where they had updated...

A draft guidance was released on 23 September 2022 by the US Food and Drug Administration on the ethical considerations for including and...

Yesterday (22 September 2022) USFDA issued “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act...

The UK MHRA released this updated guidance today and added a section on 'Advertising and promotions' to Northern Ireland MHRA Authorised...

Recently USFDA released an updated "Electronic Common Technical Document (eCTD) Technical Conformance Guide" that revised some sections...

Swissmedic on Thursday released an updated guidance document on the eDok submission which as included new templates with minor other...

Recently the Pharmacopoeial Discussion Group (PDG), which comprises the European Pharmacopoeia (Ph. Eur.), the Japanese Pharmacopoeia...

In yesterday's final rule, the U.S. Food and Drug Administration outlined (Unpublished version) the requirements for annual reports by...

The Register of Innovative Drugs is maintained pursuant to subsection C.08.004.1(9) of the Food and Drug Regulations of Health Canada and...

Earlier today (08-September-2022) USFDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research...

Earlier today on 8-September-2022, USFDA's Center for Drug Evaluation and Research, Office of New Drugs published two draft Labeling...

Yesterday 07-September-2022, USFDA's Center for Drug Evaluation and Research published a draft guideline "General Clinical Pharmacology...

On 2-September, 2022 the European Medicines Agency released the updated IRIS guidance on "How to create and submit scientific...

The Singapore Health Sciences Authority (HSA) published a Safety Alert for Finasteride on 30-August-2022. Suicidal ideation is a known...

On August 31, 2022 the EMA updated its guidance "Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections coordinated by...

Yesterday (29-August-2022) Health Canada notified that Recommendations on the Implementation of the Revised ICH Q3D(R2) Harmonized...

On August 28, the Saudi Food and Drug Authority updated its "Guide to Good Manufacturing Practice for Medicinal Products". The new...

In an announcement yesterday, USFDA released the below draft guidances for industry, developed with the assistance of ICH, the...

On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...