Regulatory Blog

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...

The Health Products Regulatory Authority published a guideline and is seeking feedback on its approach to an aspect of Clinical Trial...

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

The South African Health Products Regulatory Authority published a guideline that provides recommendations to applicants who intend to...

Yesterday, FDA issued a Small Entity Compliance Guide to help small businesses comply with the final rule on importation of prescription...

European Medicines Agency (EMA) has issued a final guideline on evaluating antibacterial medicines that follow the guidelines of other...

On 20 May 2022 MDCG, the Medical Device Coordination Group of the European Commission has released a question and answer guide for the...