News
EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
08.01.2015
This guidance document addresses a number of questions which marketing authorisation holders (MAHs) may have on post-authorisation procedures. It provides an overview of the Agency’s position on
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EMA: Draft guideline on the use of minimal residue disease as an endpoint in chronic lymphocytic leukaemia studies
18.12.2014
The scope of this document is to describe the basis and regulatory requirements for the use of minimal residue disease (MRD) as an intermediate endpoint to predict clinical benefit in trials in
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Polish Parliament: The act of December 5, 2014 concerning amendment of act - Pharmaceutical Law and other acts.
18.12.2014
This document is The act of December 5, 2014 concerning amendment of act - Pharmaceutical Law and other acts. ...
FDA: Specification of the Unique Facility Identifier (UFI) System for Drug Establishment Registration
18.12.2014
This guidance specifies the unique facility identifier (UFI) system for registration of domestic and foreign drug establishments. This guidance is intended to address provisions set forth in
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EMA: Procedure for reporting of pharmacovigilance inspections requested by the CVMP
18.12.2014
In this procedure a pharmacovigilance (PhV) inspection reports related to inspections requested by the Committee for Medicinal Products for Veterinary Use (CVMP) are detailed. The definitions,
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EMA: Recommendations for the implementation of the exemptions to the labelling and package-leaflet obligations in the centralised procedure
11.12.2014
Companies developing human medicines that are not delivered directly to patients or where there are availability issues may be exempt from some of the obligations for labelling or package
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FDA: General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products - Draft
11.12.2014
This draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who
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RAPS: EU Regulators Concerned About Drug Data Fraud by Indian Company
11.12.2014
European regulatory officials have expressed concern that dozens of medicines may have been approved in the EU based on fraudulent data conducted by a contract testing facility in Hyderabad, India. ...
URPL: nformation of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related to marketing authorization of a medicinal product since January 1, 2015.
11.12.2014
This document is an information of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products of December 10, 2014 concerning amendment of fees related
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EMA: Draft questions and answers on cyclodextrins in the context of the revision of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use\'
04.12.2014
Following the European Commission decision to revise the Annex of the guideline on ‘Excipients in the label and package leaflet of medicinal products for human use’ (CPMP/463/00 Rev. 1), a
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