GMP: FDA publishes Draft on Medical Devices Recalls Guideline

The FDA has published an independent industry guideline on product recalls, biological and medical devices (\"Product Recalls, Including Removals and Corrections\"). According to this guideline, ...

MHRA: Public consultation on Medical Devices (Amendment) Regulations 2013

The MHRA is seeking views on its approach to implementing into UK law the Commission Regulations 722/2012 on animal tissues and Commission Regulation 207/2012 on e-labelling. ...

EMA: Checking process of mock-ups and specimens of outer / immediate labelling and package leaflets of human medicinal products in the centralised procedure

The EMA has now reviewed the experience with the checking process and considers that further amendments/simplification can be introduced. This document presents the proposed revision of the ...

EMA: Rules for the implementation of Council Regulation (EC) No 297/95 on fees payable to the European Medicines Agency and other measures

This document contains revised implementing rules to the Fee Regulation as of 1 April 2013. ...

GMP: WHO\'s New Draft Guideline on Submission of Quality Data for Generic Medicinal Products

The guideline provides concrete recommendation on how to submit information within the CTD structure. The document ends with an appendix about conducting and assessing comparative dissolution ...

EMA: Concept paper on the development of medicinal products for the treatment of autism spectrum disorder

Autism spectrum disorders (ASDs) are a group of neurodevelopmental disabilities with symptoms typically presenting before the age of 3 years and persisting into adulthood. They are described as ...

GMP: Simplification of Application Submissions for Centrally Authorised Products

The document contains important information about the delivery of applications to the competent authority in the case of new marketing authorisations, renewals, type II variations, and further ...

EMA: Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia

This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic ...

Polish Ministry of Health: Project of act concerning amendment of act - Pharmaceutical law and other acts

This document is a project of act concerning amendment of act - Pharmaceutical law and other acts. ...

EMA: Reflection paper on Immune Tolerance Induction in haemophilia A patients with inhibitors

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

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