Regulatory Blog

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...

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

Abridged review refers to a limited independent assessment of specific parts of the dossier, or submission for suitability of use under...

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...

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood...

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...

Health Sciences Authority (HSA) updated its "GUIDANCE ON THERAPEUTIC PRODUCT REGISTRATION IN SINGAPORE" recently, which describes the...

Guidance Document Authorisation of the human medicinal product with known Active Pharmaceutical Substance Medicinal products with known...

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

On 2 June, an official Q&A prepared by the European Commission (EC), European Medicines Agency (EMA), and the Heads of Medicines Agencies...