Non-pharmaceutical products - European Medicines Agency
In the non-pharmaceutical products section there is regulatory and procedural information on: Plasma Master File (PMF) Ancillary medicinal substances
Binders, fillers and more? What’s all that other stuff in my medicine?
May 9, 2024 · Pharmaceuticals all contain an array of binders, coatings, supplements and fillers. But rather than being a negative feature, these supplementary, non-medicinal ingredients play …
Development of a human umbilical cord-derived mesenchymal …
Umbilical cord-derived mesenchymal stromal cells (UC-MSCs) revealed their key role in immune regulation, offering promising therapeutic perspectives for immune and inflammatory diseases.
How to achieve safe, high-quality clinical studies with non-Medicinal …
The aim of this article is to 1) briefly review the current guidelines and regulations for Investigational Medicinal Products; 2) present a standardised approach to ensure the quality …
Products without an intended medical purpose: EU clarifies …
Dec 20, 2022 · Non-medical product manufacturers have limited time to prepare for new risk management and clinical data obligations. An implementing regulation (EU) 2022/2346 on …
Drugs and non-medical products sold in pharmacy: information …
From this survey, it emerged that most of the respondents go to pharmacy to purchase drugs exclusively and only a small number of people go to purchase other products. The pharmacist …
Development of a human umbilical cord-derived mesenchymal …
Nov 13, 2021 · Background: Umbilical cord-derived mesenchymal stromal cells (UC-MSCs) revealed their key role in immune regulation, offering promising therapeutic perspectives for …
Excipients and Non-medicinal Agents as Active Pharmaceutical ...
Jan 1, 2015 · This chapter intends to highlight atypical actives and non-medicinal agents in OTC drug products with an emphasis on their therapeutic properties.
ISPE Releases New Guidance for Definition and Use of Non
Feb 7, 2013 · The ISPE Good Practice Guide: Harmonizing the Definition and Use of Non-Investigational Medicinal Products helps companies who operate studies in multiple countries …
This section provides guidance on some categories of medicinal products which are normally used in clinical trials as non-investigational medicinal products (NIMPs).