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GMP: FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI)

06.09.2012
The FDA announced via its Center for Devices and Radiological Health (CDRH) - which is also responsible for medical devices - the publication of requirements on harmonised designation of medical ...

GMP: FDA Dissolution Methods Database

06.09.2012
The U.S. Food and Drug Administration has created the FDA Dissolution Methods Database for drug products that do not have a drug product dissolution test method in the United States Pharmacopeia ...

EMA: Draft guideline on core summary of product characteristics and package leaflet for technetium (99mTc) sestamibi

29.08.2012
This guideline describes the information to be included in the summary of product characteristics and package leaflet for technetium (99mTc) sestamibi. ...

GMP: Continuous Manufacturing - FDA Perspective on Submissions and Implementation

29.08.2012
The advantages of Continuous Manufacturing (CM) are presented in a presentation entitled \"Continuous Manufacturing - FDA Perspective on Submissions and Implementation\". The presentation points ...

GMP: New Templates for GMP and GDP certificates published by EMA

29.08.2012
The compilation is a tool for facilitating co-operation between the GMP inspectorates of the Member States and a means of achieving harmonisation. ...

GMP: New Rules for the Importation of APIs - a European Commission Leaflet provides Information

23.08.2012
The rules for importing active substances for medicinal products for human use from third countries into the EU have been reformed. The European Commission has already published a document setting ...

GMP: FDA Expectations concerning Real Time Release Testing (RTRT)

23.08.2012
RTRT is defined as the ability to evaluate and ensure the quality of products based on process data. The FDA has published an interesting presentation on its website entitled \"Regulatory ...

GMP: New EMA Guideline on Real Time Release Testing

23.08.2012
Medicinal products must comply with the requirements stated in the authorised specifications before they can be released for sale. The EMA has published a new Guideline on Real Time Release ...

GMP: Revised Guideline on Renewals in the Centralised Procedure Effective!

23.08.2012
How renewals in the centralised procedure should be processed is described in the \"Guideline on the processing of renewals in the centralised procedure\". The document describes a 120-day ...

EMA: Questions and answers on practical transitional measures for the implementation of the pharmacovigilance legislation

09.08.2012
This Question and Answer (Q&A) document provides practical considerations concerning the initial phases of operation of the new pharmacovigilance legislation (Regulation (EU) No 1235/2010 and ...