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HMA: Requirements on Electronic Submissions (NeeS and eCTD) and Paper Documentation for New Applications within MRP, DCP or National Procedures.

12.08.2011
This document describes the documentation requested by each National Competent Authority for new applications for approval for Marketing Authorisation. ...

HMA: Contact Points for Advice on Mutual Recognition and Decentralised Procedures.

12.08.2011
The list is provided to assist pharmaceutical companies identifying a contact point for advice on the Mutual Recognition or Decentralised Procedures in each Member State. The persons listed should ...

HMA: Procedural Advice on Repeat-Use.

12.08.2011
This document describes the procedure to be adopted for “Repeat Use”. ...

HMA: Recommendation for Marketing Authorisation Holders on the Pharmacovigilance System and Risk Management Plan in the Mutual Recognition and Decentralised Procedures.

12.08.2011
This CMDh guidance document aims to provide specific guidance for RMS and CMS on the submission of data related to Pharmacovigilance systems, the necessity for submission of Risk Management Plans ...

GMP: Revised EU Guideline on Good Distribution Practice with major Changes

12.08.2011
The guideline was revised to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it should take into ...

EMA: Risk Based Quality Management in Clinical Trials.

09.08.2011
The purpose of this reflection paper is to facilitate the development of a more systematic, prioritised, risk-based approach to quality management of clinical trials, to support the principles of ...

GMP: FDA proposes Changes in Sterility Testing of Biological Products.

09.08.2011
The proposed rule is intended to provide manufacturers of biological products with greater flexibility and to encourage the use of the most appropriate and state-of-the-art test methods for ...

EMA: New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation.

09.08.2011
This guideline addresses the requirements in terms of stability testing data which drug manufacturers have to provide when applying variations to a marketing authorisation. Due to the extensive ...

FDA: PET Drugs — Current Good Manufacturing Practice (CGMP)

09.08.2011
This guidance is intended to help small businesses better understand and comply with the regulations issued by FDA concerning current good manufacturing practice (CGMP) for positron emission ...

GMP: New FDA Draft Guidance regarding Design Development of Medical Devices.

09.08.2011
The goal of this guidance is to assist the medical devices industry in performing appropriate human factors testing on medical devices in order to reduce use error and injuries. The FDA hopes that ...