Regulatory Blog

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

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

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US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC)...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

US Food and Drug Administration (FDA) has finalized guidance for industry and agency staff on the use of Principles of Premarket Pathways...

On January 28, 2022 Swismedic released a list of guidances for different segments, check out the below important list of swiss medic...

This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling...

FDA published a series of guidances on January 26, 2022 focussing on Generic Drug Application Submissions, Labeling, and Review. These...

On January 20, 2022, the UK MHRA released guidance on how to complete your Electronic Application Form (eAF) and Cover Letter. This form...

China’s National Medical Products Administration (NMPA) released 2 guidelines supporting the development and registration of drug-device...

UK MHRA updated its guidance on How to apply for a clinical trial including eligibility, phases, model IMPDs, costs, and how to make...

SFDA updated their Biowaiver guideline recently. These guidelines are intended to facilitate and support the workflow of drug...

Yesterday U.S. Food and Drug Administration issued an emergency use authorization (EUA) for Pfizer’s Paxlovid (nirmatrelvir tablets and...

Priority Review indicates that the review process of the application will be expedited by the concerned departments. However, the...

This new pathway supports innovative approaches to the safe, timely, and efficient development of medicines to improve patient access....

Senior US Senator Chuck Grassley has urged to "reinstate unannounced" inspections of prescription drug manufacturing facilities in...

This guidance was developed within the Expert Working Group (Quality) of the International Council for Harmonisation of Technical...

This guidance provides recommendations to holders of biologics license applications (BLAs) for specified biological products regarding...