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GMP: ICH announces Q&A Document on Q11 Guideline - Main Focus: API Starting Materials

15.01.2015
The ICH Q11 Guideline entitled \"Development and Manufacture of Drug Substances\" from May 2012 has been implemented in the three ICH regions EU, USA and Japan for 2 years now. It describes the ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) M2 on electronic common technical document (eCTD) - file format criteria - Step 5

15.01.2015
ICH M2 EWG pursued the challenging task of recommending international solutions by identifying the key areas (domains) that demanded M2\'s immediate attention. ICH M2 EWG concluded that the best ...

RAPS: China May Soon Allow Online Drug Sales

15.01.2015
Regulators in China are looking to allow online sales of prescription medicines starting in early 2015, according to Reuters. A senior healthcare policy worker told the publication the China Food ...

EMA: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

15.01.2015
The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/05 Rev.1) lays down the ...

EMA: Reflection paper on the use of heat treatment to inactivate retrovirus RD114 in live immunological veterinary medicinal products (IVMPs)-draft

08.01.2015
This guideline outlines the data requirements to be submitted by the marketing authorisation holder (MAH) to introduce a heat treatment to inactivate retroviruses in the active substance for the ...

URPL: Announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of Supplement 8.3 of eighth edition of European Pharmacopoeia (Ph. Eur.).

08.01.2015
This document is an announcement of President of The Office for Registration of Medicinal Products, Medical Devices and Biocidal Products concerning content of Supplement 8.3 of eighth edition of ...

EMA: Guidance on the classification of veterinary medicinal products indicated for minor use minor species (MUMS)/limited market - draft

08.01.2015
This guidance document relates to requests from applicants seeking to access incentives for MUMS/limited market products where a request for classification is made to the Committee for Medicinal ...

Polish Parliament: The act of December 19, 2014 concerning amendment of act - Pharmaceutical Law and other acts.

08.01.2015
This document is a final version of the act of December 19, 2014 concerning amendment of act - Pharmaceutical Law and other acts. ...

EMA: Guideline on core SmPC for human plasma derived and recombinant coagulation factor IX products

08.01.2015
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for human plasma derived and recombinant coagulation factor IX products, which are ...

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 ...