Regulatory Blog

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Today (August 2, 2022) FDA published draft guidance for the industry, “Electronic Submission of Expedited Safety Reports from IND-Exempt...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 this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...

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

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...

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...

Recently on 14-July 2022, SwissMedic updated their "Packaging for human Medicinal Products" guidance. This guidance document explains how...

On 22-July 2022, USFDA released multiple guidance among them one is "Failure to Respond to an ANDA Complete Response Letter Within the...

On 22-July 2022, USFDA released multiple guidance among them one is "Orange Book Questions and Answers Guidance for Industry. What is...

On 22-July 2022, USFDA released multiple guidance among them one is "Conducting Remote Regulatory Assessments Questions and Answers"....

Clinical trials for Medicines: Apply for Authorisation in the UK (18 July 2022) This updated guidance will detail how to apply for a...

This updated guidance provides recommendations on an alternate electronic format for submissions covered under an exemption from or a...

This guideline aims to classify the requirements for submitting a renewal of marketing authorization and to provide applicants with...

India's Ministry of Health and Human Welfare has released a draft proposal on 14th June, 2022 which suggests to add barcodes or quick...