EN PL

News

Polish Office of Registration: Statement amending Ordinance on the fees payable in relation to placing medicinal product on the market came into force on 06.04.2011

05.04.2011
The President of the Office for Registration of Medicinal Products, Medical Cevices and Biocidal Products hereby informs that Ordinance of the Minister of Health of 02.03.2011 amending Ordinance ...

FDA: Postmarketing Studies and Clinical Trials — Implementation of Section 505(o)(3) of the Federal Food, Drug, and Cosmetic Act

31.03.2011
This guidance provides information on the implementation of new section 505(o) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 355(o)), added by section 901 of the Food and Drug ...

EMA: Draft guideline on requirements for the production and control of immunological veterinary medicinal products

30.03.2011
This document provides information on items to be considered for the production and control of all immunological veterinary medicinal products (IVMPs). The guideline outlines important items ...

EMA: European Medicines Agency post-authorisation procedural advice for users of the centralised procedure

25.03.2011
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 ...

EMA: ICH Topic Q3C (R5) Impurities: Guideline for residual solvents

25.03.2011
The objective of this guideline is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the patient. The guideline recommends use of less toxic solvents and ...

EMA: Concept paper on potency declaration / labelling for biological medicinal products which contain modified proteins as active substance

18.03.2011
This concept paper aims to provide the rationale for drafting a guidance document for potency assignment of modified proteins for which an International Standard exists or where a clinical ...

EMA: European Medicines Agency announces start of process improvement of core business procedures

18.03.2011
The programme aims to improve the efficiency of processes in order to support the Agency’s capabilities to deliver sustainable results. The programme will initially focus on processes for the ...

EMA: European Medicines Agency and U.S. Food and Drug Administration announce pilot program for parallel assessment of Quality by Design applications

16.03.2011
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) are launching a three-year pilot program that will allow parallel evaluation of relevant quality data ...

EMA: Guideline on the evaluation of drugs for the treatment of gastro-oesophageal reflux disease

14.03.2011
This guideline intends to address the EU regulatory position on the main topics of the clinical development of new medicinal products in the treatment of patients with gastro-oesophageal reflux ...

EMA: Procedural advice on the evaluation of combined advanced therapy medicinal products and the consultation of notified bodies in accordance with Article 9 of Regulation (EC) No. 1394/2007

03.03.2011
Advanced Therapy Medicinal Products (ATMPs) offer new treatment opportunities for diseases and injuries of the human body. The regulatory framework established by the new legislation on ATMPs is ...