Regulatory Blog

On August 23, the Saudi Food and Drug Authority updated its "Guidelines for Stability Testing of Active Pharmaceutical Ingredients and...

EudraVigilance is the system for managing and analysing information on suspected adverse reactions to medicines which have been...

On 22-August-2022, Sunlenca (lenacapavir) is an injectable HIV medication developed by Gilead Sciences that has been approved to market...

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational...

Today (17 August 2022) MHRA updated its Guidance on "Medicines: apply for a parallel import licence" The guidance in general details...

Nitrosamines are chemical compounds classified as probable human carcinogens on the basis of animal studies. EU regulators first became...

Today (9 August 2022) MHRA updated their Guidance on Clinical trials for medicines to manage authorisation, and report safety issues. The...

Recently the National Institute for Food and Drug Surveillance - Invima and the United States Pharmacopeia - USP, celebrated the signing...

Friday the USFDA agency published a new web page to share the most recent FDA actions and activities related to complex generics, which...

Health Canada on August 2, 2022, revised the Guidance Document entitled: The Management of Drug Submissions and Applications (MDSA). This...

Today (August 4, 2022) UK Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance for the industry, “Guidance:...

Yesterday (01.08.2022) the Swiss Medic updated their "Guidance document on Authorisation procedures for Covid-19 medicinal products...

Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...

Multiple guidances were updated and released by the USFDA last week and had some important updates related to Drugs, Biologics, and...

On 8 July 2022, EMA updated its Products Management Services - Implementation Guide "Implementation of International Organization for...

Earlier Monday, China's drug regulator granted conditional approval for an HIV drug to treat COVID-19. This is the first oral antiviral...

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) has updated its variation guideline for pharmaceutical products to be in...

Recently EMA released new guidance for "patients and healthcare professionals’ organisations" with key principles and examples of good...

A technology capability investment plan has been published by the European Medicines Agency (EMA), which outlines how it plans to invest...

On July 22, 2022, FDA announced the availability of a proposed rule, Revising the National Drug Code Format and Drug Label Barcode...