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

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)

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

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!

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

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 ...

EMA: Draft guideline on the use of the CTD format in the preparation of a registration application for traditional herbal medicinal products

This document aims to provide guidance on how to present the application for registration of traditional herbal medicinal products (THMPs) in the Common Technical Document (CTD) format, providing ...

GMP: Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012

The document is supposed to help accomplishing an administrative harmonisation which should facilitate the processing of an ASMF by authorities and improve communication between the ASMF holder, ...

EMA: Final Guideline on clinical investigation of medicinal products in the treatment of chronic obstructive pulmonary disease (COPD)

This guideline is a revision of the CPMP Points to Consider on Clinical Investigation of Medicinal Products in the Chronic Treatment of Patients with Chronic Obstructive Pulmonary Disease (COPD) ...

EMA: Reflection paper on immune tolerance induction in haemophilia-A patients with inhibitors

In haemophilia-A patients, replacement therapy with factor-VIII (FVIII) products has become state of the art. However, a serious complication in the treatment of haemophilia A is the development ...

EMA: Draft guideline on core summary of product characteristics for human normal immunoglobulin for subcutaneous and intramuscular administration

This guideline describes the information to be included in the summary of product characteristics for human normal immunoglobulins for subcutaneous or intramuscular administration. ...

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