The implementation of an effective quality management system has always been considered a principal method for a manufacturer to maintain and improve its product and service quality. Globally many regulatory authorities incorporate quality management system as one of the mandatory requirements for the regulatory control of high-risk medical devices. The present study aims to analyze the GMP enf...

Recommendations published by WHO are intended to be scientific and advisory. Each of the following sections constitutes guidance for national regulatory authorities and for the manufacturers of biological products. If a national regulatory authority so desires, these Recommendations may be adopted as definitive national requirements, or modifications may be justified and made by the national re...

During faecal microbiota transplantation, stool from a healthy donor is transplanted to treat a variety of dysbiosis-associated gut diseases. Competent authorities are faced with the challenge to provide adequate regulation. Currently, regulatory harmonization is completely lacking and authorities apply non-existing to most stringent requirements. A regulatory approach for faecal microbiota tra...

This document provides a comprehensive review of the information and data relevant to the environmental risk assessment of Cry1F, a family of proteins encoded by genes isolated from Bacillus thuringiensis (Bt), and it presents a summary statement about the environmental safety of these proteins when produced in genetically engineered (GE) cotton (Gossypium hirsutum) and maize (Zea mays) plants....

Risk governance is a major challenge in the twenty-first century. Governments and regulatory authorities are required to deliver the best possible risk governance to society. However, in a globalized world, their performance is increasingly assessed at the international level by using the best scientific knowledge available. Companies face a renewed demand for social and public responsibility a...

Since 1997, in order for a new drug to obtain its price and reimbursement in Italy, the negotiation between authorities and the pharmaceutical industry must include an economic evaluation. The economic evaluation study leads to price and reimbursement negotiations together with such other requirements as the price of the new drug in other countries, the impact on the domestic market in terms of...

The World Organisation for Animal Health (OIE) TerrestrialAnimal Health Code considers the prudent use of antimicrobial agents in veterinary medicine to comprise a series of practical measures and recommendations which confer benefits to animal and public health while preserving and maintaining the therapeutic efficacy of antimicrobials. This paper reviews some of the main veterinary prudent us...