GMP: New EMA Guideline on Specifications for Impurities in Antibiotics

EMA published the final \"Guideline on Setting Specifications for Related Impurities in Antibiotics\" (EMA/CHMP/QWP/199250/2009) which is coming into effect one year after on 30 June 2013. ...

GMP: EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines

The sensitivity of modern detection methods increased considerably during the last years. The development includes that the detection limits of adventitious agents decreased considerably too. ...

MHRA: Public consultation (MLX380): European Commission’s proposal for a Clinical Trials Regulation

The European Commission proposes to simplify the rules for the conduct of clinical trials and harmonise the way trials are conducted in the European Union. The proposed Regulation will replace the ...

GMP: New rules for Medical Devices published by the EU - significantly tightened Controls planned

On 26 October 2012 the European Commission published proposals to ensure that especially patients can reap the benefits of safe, effective and innovative medical devices. But the proposals also ...

GMP: QP for Manufacturers of Medical Devices - New EU Requirement?

Regarding medical devices, article 13 of the proposal introduces a new role for manufacturers of medical devices: A person responsible for regulatory compliance, subsequently referred to as ...

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

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.

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

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

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

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 ...

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