Regulatory Blog

The Health Products Regulatory Authority (HPRA) Ireland released updated guidance on the "Guide to Wholesaling and Brokering of...

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...

1. Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR This guidance is intended to provide information to applicants...

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...

FDA is issuing this draft guidance "Verification Systems Under the Drug Supply Chain Security Act for Certain Prescription Drugs Guidance...

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As a result of this guidance, the July 2013 draft guidance Pre-Launch Activities Importation Requests (PLAIR) has been finalized, which...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

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...