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GMP: Delegated Regulation on GMP for APIs published in the Official Journal of the EU

04.12.2014
On 25 November 2014, the \"Commission Delegated Regulation (EU) No 1252/2014\" was published in the Official Journal of the European Union. ...

EMA: Concept paper on revision of the addendum to the note for guidance on evaluation of medicinal products indicated for treatment of bacterial infections to specifically address the clinical development of new agents to treat disease due to Mycobacteriu

04.12.2014
This concept paper proposes a revision of the Committee for Medicinal Products for Human Use\'s (CHMP’s) addendum to the note for guidance on evaluation of medicinal products indicated for ...

EMA: Questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into EudraVigilance

04.12.2014
This document contains questions and answers relating to open procurement procedure EMA/2014/48/PH - Monitoring of scientific and medical literature and the entry of relevant information into ...

EMA: Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities

27.11.2014
This document aims to recommend an approach for deriving a scientifically based threshold value for individual active substances to be applied for risk identification. The guideline outlines how ...

FDA: Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act

27.11.2014
This guidance is intended for facilities planning to register or renew registration as human drug compounding outsourcing facilities (outsourcing facilities). This guidance describes the process ...

EMA: Guideline on the use of phthalates as excipients in human medicinal products

27.11.2014
This guideline covers the phthalates most commonly used as excipients in medicinal products authorised in the EU. The recommendations provided in this document apply to new and existing marketed ...

GMP: New Q&A concerning Visual Inspection

27.11.2014
The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL ...

EMA: Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases

20.11.2014
Vectors are living organisms - such as diptera (mosquitoes, sand flies, muscid flies), ticks, fleas and lice - that transmit a disease from an infected animal to a human or another animal. ...

EMA: Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species

20.11.2014
The European Medicines Agency, together with the European medicines regulatory network, aims to facilitate the access of products indicated for minor use minor species (MUMS) / limited market to ...

FDA: Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry

20.11.2014
This guidance provides information on the implementation of section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which added section 529 to the Federal Food, Drug, ...