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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 ...

Polish Ministry of Health: The Regulation of Polish Minister of Health of September 18, 2014 concerning variations in marketing authorization of veterinary medicinal product.

09.10.2014
This document is the Regulation of Polish Minister of Health of September 18, 2014 concerning variations in marketing authorization of veterinary medicinal product. ...

EMA: Draft guideline on regulatory acceptance of 3R (Replacement, Reduction, Refinement) testing approaches

09.10.2014
In accordance with Directive 2010/63/EU, the principle of the 3Rs (Replacement, Reduction and Refinement) needs to be considered when selecting testing approaches to be used for regulatory testing ...

RAPS: FDA Announces Major Regulatory Changes, With Specialization a Key Focus

09.10.2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of ...

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

09.10.2014
Regulatory functions at the US Food and Drug Administration (FDA) are set to undergo a major overhaul in the coming months after a year-long effort by the agency recommended making scores of ...