This document is intended to guide the submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate...
The PRIME scheme aims to support the development of novel medicines that target an unmet clinical need in conditions that are seriously debilitating or life-threatening. The scheme offers enhanced support to...
The technical and regulatory aspects of drug development and production, encompassing the chemical composition of the drug substance, its manufacturing process, and the controls implemented to ensure its quality...
In the fast-paced world of pharmaceuticals, maintaining quality and compliance is of utmost importance. One crucial aspect of the drug development process is the Drug Master File (DMF) writing guideline. The DMF serves...
The revision 1 of the MDCG 2019-07 Guidance on Article 15 of the Medical Device Regulation (MDR) and In Vitro Diagnostic Device Regulation (IVDR) on #PRRC has been published in December...
The New SAHPRA eCTD site can be accessed via SAHPRA website. The new specifications, guidelines and validation criteria is effective 1 October 2024 allowing adequate time for implementation –...
In the realm of pharmaceuticals, ensuring patient safety, optimizing regulatory processes, and fostering global collaboration are paramount. Enter IDMP, an acronym that stands for Identification of Medicinal Products. While...
When submitting general medical devices for approval in the ASEAN region, it is essential to follow the guidelines and standards set by the ASEAN Common Submission Dossier Template (CSDT)...
The revised EDQM guideline “content of the dossier” and other key documents will be useful tools With effect from May 1, 2024, the updated EDQM guideline “Content of the...
In the world of business, certain identifiers hold significant importance, and one such identifier is the DUNS number. Short for Data Universal Numbering System, a DUNS number is a...
