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EMA: Scientific guideline: Reflection paper on the need for active control in therapeutic areas where use of placebo is deemed ethical and one or more established medicines are available, draft:

14.01.2011
This paper describes regulatory considerations, and expectations of applicants, in discussing the importance of a direct comparison to active control for a properly informed decision on ...

MHRA: Medicines for children: Publication of assessment reports for European Article 45 and 46 paediatric work-sharing procedures

14.01.2011
In November 2010, the CMDh (Co-ordination Group for Mutual Recognition and Decentralised Procedures) published three more paediatric assessment reports following completion of Article 45 ...

FDA: Electronic Source Documentation in Clinical Investigations

14.01.2011
This document provides guidance to sponsors, contract research organizations (CROs), data management centers, and clinical investigators on capturing, using, and archiving electronic data in ...

FDA: Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements

14.01.2011
This guidance provides recommendations to industry regarding postmarketing adverse event reporting for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. FDA ...

EMA; Regulatory and procedural guideline: Procedure for calls for scientific data for use in HMPC assessment work

05.01.2011
In accordance with Directive 2004/24/EC (1), amending as regards traditional herbal medicinal products, Directive 2001/83/EC, it is the task of the Committee on Herbal Medicinal Products (HMPC) to ...

EMA: Glossary on herbal teas

05.01.2011
The purpose of this paper is to define the terms applied to the preparation of herbal teas by patients. The definitions will help to clarify the terms used to describe the preparation of herbal ...

EMA: Scientific guideline: Reflection paper on the level of purification of extracts to be considered as herbal preparations

05.01.2011
This reflection paper applies to extracts used as active substances in herbal medicinal products (HMPs) both for human and veterinary use and in traditional herbal medicinal products (THMPs) for ...

Polish Ministry of Health: Regulation concerning reimbrusement of medicinal products and guaranteed benefits related to therapies.

29.12.2010
The package of regulations concerning registers of prices of medicinal product, medical devices and registers of basic and supplementary medicinal products. ...

Polish Ministry of Health: Regulation concerned GMP requirements

29.12.2010
Regulation concerning the Good Manufacturing Practice requirements and some changes related to this regulation. ...

EMA: Regulatory and procedural guideline: European Medicines Agency pre-submission procedural advice for users of the centralised procedure

29.12.2010
This guidance document addresses a number of questions which users of the Centralised Procedure may have. It provides an overview of the European Medicines Agency’s position on issues, which are ...