News
MHRA: Public consultation (MLX380): European Commission’s proposal for a Clinical Trials Regulation
08.11.2012
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
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GMP: New rules for Medical Devices published by the EU - significantly tightened Controls planned
02.11.2012
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
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GMP: QP for Manufacturers of Medical Devices - New EU Requirement?
02.11.2012
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
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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
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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
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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
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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
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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
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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
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