Regulatory Blog

On 28-February-2022, the US Food and Drug Administration (FDA) finalized guidance to assist sponsors in collecting and submitting...

As part of the manufacturing import authorisation (MIA) process, the Annex outlines the GMP requirements that must be followed when...

ePI refers to medicines' authorised, statutory information (including summary of product characteristics, package leaflet and labeling)...

Medical devices that are innovative play an important role in improving and facilitating the quality of life of both patients and...

Throughout this guide, guidance is given on the qualification of medical devices and the application of classification rules. There is a...

A number of important revisions and clarifications were made in the HPRA's Guide to Labels and Leaflets of Human Medicines on 9 February...

Malaysia's Medical Device Authority (MDA) has published guidelines to help manufacturers and authorized representatives submit...

In 2022, CDER will publish new and revised guidances in its Guidance Agenda, which was released on January 31, 2022. The 2022 list...

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...

On 3-February, 2022 Ireland adopted a new guideline the "EU Clinical Trial Regulation" (Regulation No 536/2014, hereafter ‘CTR’), was...

On 1-February 2022, the Pharmaceutical Inspection Co-operation Scheme (PIC/S) this week revised its good manufacturing practice (GMP)...