Regulatory Blog

On 11-March-2022, FDA released the final guidance "Providing Regulatory Submissions in Electronic and Non-Electronic 1 Format —...

On 7 April 2022, European Medicines Agency released a draft guidance document on how to approach the protection of personal data and...

As part of its recent announcement, the International Council for Harmonization (ICH) released on 4 April 2022, a draft E11A guideline...

On 29-March-2022, a guidance document titled "Malaysian Guidance Document on Voluntary Good Pharmacovigilance Practices (GVP) Inspection"...

Two draft guidelines were issued by the International Council for Harmonization (ICH) on 31 March 2022 (Thursday), intended to support...

A new how-to guide was published by the International Pharmaceutical Excipients Council (IPEC) to assist the pharmaceutical industry in...

On 18 March 2022, EMA released updated guidance on "European Medicines Agency post-authorisation procedural advice for users of the...

Guideline on Good Pharmacovigilance Practices (GVP) for Pregnancy Prevention Programs A public consultation was launched by the European...

This guidance document describes the rules that apply to the renewal or discontinuation of authorisation, how these rules are to be...

The MHRA on 17-March-2022 updated its Guidance on Advertise your medicines which details how to comply with the requirements on promoting...

Yesterday USFDA published the fees for over-the-counter (OTC) monograph drugs for fiscal year (FY) 2022 in a Federal Register Notice...

On 11-March-2022, SwissMedic released updated guidance on "Packaging for Human Medicinal Products". The purpose of this document is to...

Project Orbis aims to review and approve promising cancer treatments to help patients access treatment faster. MHRA recently added...

As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...

The purpose of this document is to inform applicants on how to submit variations to the South African Health Products Regulatory...

MHRA, the UK Medicines and Healthcare Products Regulatory Agency has updated its guidance information on the Innovative Licensing and...

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)...

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