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GMP: New EMA\'s Reflection Paper on API Starting Materials

23.10.2014
EMA released a document entitled \"Reflection paper in the requirements for selection and justification of starting materials for the manufature of chemical active substances\". The paper was ...

EMA: Substances considered as not falling within the scope of Regulation (EC) no 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin

23.10.2014
Regulation (EC) No. 470/2009 of 6 May 2009 lays down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin. The ...

GMP: EDQM revises 5.1.10. Guidelines for using the Test for Bacterial Endotoxins

23.10.2014
In September, the European Directorate for the Quality of Medicines & HealthCare (EDQM) published in Pharmeuropa online the information about their new policy for bacterial Endotoxins, which was ...

MHRA: EMA public consultation on functional specification for portal and database that will underpin the EU Clinical Trials Regulation

23.10.2014
One of the features of the EU Clinical Trials Regulation No 536/2014 is the creation of the EU portal and the EU database for clinical trials. The Regulation and systems infrastructure provided by ...

EMA: European Medicines Agency guidance for applicants seeking scientific advice and protocol assistance

16.10.2014
This guidance document addresses a number of questions that users of the scientific advice or protocol assistance procedures may have. It provides an overview of the procedure to obtain scientific ...

RAPS: Chinese Company Used Suppliers Linked to Contaminated Heparin Scandal, FDA Claims

16.10.2014
A Chinese-based manufacturer of heparin products has been sent a Warning Letter by the US Food and Drug Administration (FDA) after regulators accused the company of preventing FDA inspectors from ...

GMP: Final Concept Paper ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle

16.10.2014
ICH has just published a Final Concept Paper for a new ICH Q12 guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle. Currently, there is a lack of a harmonised ...

EMA: Reflection paper on the requirements for selection and justification of starting materials for the manufacture of chemical active substances

16.10.2014
This reflection paper aims to clarify some of the expectations of EU competent authorities arising from the guidance found in ICH Q11 (Development and Manufacture of Drug Substances (Chemical ...

RAPS: New Fixed-Dose Combination Drugs Now Eligible for 5 Years of Exclusivity, FDA Says

16.10.2014
The US Food and Drug Administration (FDA) has finalized a new policy which will for the first time allow new fixed-dose combination (FDC) drugs consisting of at least one new drug product to be ...

EMA: Questions and answers on the European Medicines Agency policy on publication of clinical data for medicinal products for human use

09.10.2014
The European Medicines Agency (EMA) has committed to continuously extending its approach to transparency. A key goal in this process is the proactive publication of clinical-trial data for ...

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