Regulatory Blog

The French National Agency for Medicines and Health Products Safety (ANSM) has released guidance on the development of shortage...

This guidance document addresses a number of questions that users of the centralised procedure may have. It provides an overview of the...

The European Medicines Agency (EMA) on 22-July-2021 has adopted a guideline on the quality information that manufacturers of combination...

ICH on 27 July 2021, confirmed that the ICH Q13 Guideline on Continuous Manufacturing of Drug Substances and Drug Products reached Step 2...

FDA on July 26, 2021, published a revision to the Manual of Policies and Procedures (MAPP 5230.3), “Generic Drug Labeling Revisions” The...

Clinical Trials Information System (CTIS) will act as the single entry point for clinical trials authorisation and supervision in the...

FDA announced the availability of a final guidance for the industry entitled "Field Alert Report (FAR) Submission: Questions and...

Guidance document Packaging for Human Medicinal Products HMV4 This guidance document explains how primary and secondary packaging...

The Medicines and Healthcare products Regulatory Agency (MHRA) is ensuring that the UK remains one of the best places in the world to...

European Medicines Agency (EMA) has assessed several rare adverse events for COVID-19 vaccines and one gene therapy for treating...

The US Food and Drug Administration (FDA) yesterday (06-July-2021) finalized its guidance on the form and content requirements for unique...

The Medicines and Healthcare products Regulatory Agency (MHRA) publishes its Delivery Plan 2021-2023 ‘Putting patients first. This Plan...

A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices. The TGA...

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) announced that its new guidance on good practices for data management and...

This guidance provides recommendations for clinical trials designed to assess the adhesion performance of transdermal and topical...

The US Food and Drug Administration on 1st-July,2021 issued final guidance to assist sponsors in using alternate electronic formats for...

The European Medicines Agency (EMA) has issued a list of five preferred therapeutics for COVID-19 patients, including four monoclonal...