Regulatory Blog

Yesterday (13-September,2022) FDA published a new webpage to share the most recent research activities of the Center for Drug Evaluation...

Recently the MHRA updated its Medical devices: Software Applications (apps) guidance, which provides information on when software...

Association of Southeast Asian Nations, or ASEAN, is a political and economic union of 10 members states in Southeast Asia, which are...

On 1-September, 2022 Swissmedic released the updated guidance on " Guidance document On Export Certificates". Swissmedic issues export...

The National Institute for Food and Drug Surveillance - Invima, informs manufacturers and importers of controlled technology medical...

The Australian Regulatory Guidelines for Medical Devices (ARGMD) released updated guidance on 19-August-2022, which provides information...

Today USFDA's Center for Devices and Radiological Health updated multiple guidances such as "Regulatory Requirements for Hearing Aid...

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

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

Earlier this Thursday the Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance on how to register your medical...

Recently the Indian Central Drugs Standard Control Organization (CDSCO) released three draft guidance documents, where the In vitro...

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

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

The South African Health Products Regulatory Authority (SAPHRA) did a few Administrative updates and amendments in its Post-marketing...

On 15-June-22, the HPRA released a guide on how to Performance Studies Conducted in Ireland. The term ‘performance study’ (PS) is defined...

According to the guidance document, FDA recommends what information should be included in a premarket submission for radiological devices...

FDA published a new Manual of Policies and Procedures (MAPP), “Assessment of the User Interface of a Drug-Device Combination Product...

Malaysia’s Medical Device Authority (MDA) & Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) has updated guidance updates...

On 3 June, USFDA's Center for Devices and Radiological Health & Center for Biologics Evaluation and Research released updated guidance...

According to the U.S. Food and Drug Administration (FDA), the purpose of a "CAPA program is to collect information, analyze information,...