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EMA: Concept paper on the need for revision of the guideline on the evaluation of medicinal products in the treatment of primary osteoporosis

02.11.2012
The proposed guideline will replace guideline on the evaluation of medicinal products in the treatment of primary osteoporosis (CPMP/EWP/552/95 Rev. 2). ...

EMA: The linguistic review process of product information in the centralised procedure – human.

02.11.2012
A linguistic review of product information in all EU languages is performed after the adoption of CHMP Opinions to ensure high quality and consistent product information of Centrally Authorised ...

EMA: Concept paper for the revision of the guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestations in dogs and cats

25.10.2012
The last revision of the current guideline came into effect in June 2008. Since that time new aspects for guidance came up which were addressed in a Question and Answer (Q&A-) document ...

GMP: Draft Guideline on Good Distribution Practices for Biological Products published by CDSCO

25.10.2012
The Central Drugs Standard Control Organization (CDSCO), India\'s Authority for Medicinal Product, has published a draft Guideline on Good Distribution Practice (GDP) for biological products. The ...

EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

25.10.2012
On 23 July 2010 and after a consultation phase, the EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any ...

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

25.10.2012
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 ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of acute heart failure

18.10.2012
The CHMP Note for Guidance on the Clinical Investigation of Medicinal Products for the Treatment of Cardiac Failure (CHMP/EWP/235/95, rev. 1) provides limited regulatory guidance for development ...

GMP: WHO publishes revised Draft Guideline on Quality Risk Management

18.10.2012
In our GMP News from 23 September 2010, we referred to a draft guideline of the WHO on quality risk management (QRM). Now, this draft has been revised and published for comment. The new document ...

GMP: Additional Guidance Document on Active Substance Master File (ASMF) published by EMA

18.10.2012
The European Medicines Agency (EMA) has published an additional Guidance document relating to Active substance Master Files (formerly known as European Drug Master File). The new document will ...

GMP: FDA requires Registration of Manufacturing Facilities until December 2, 2012

18.10.2012
In a Federal Register Notice dated October 2, 2012 the FDA is notifying companies who manufacture Generic Drug Products and Active Pharmaceutical Ingredients as well as certain other sites and ...