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EMA: Concept paper on the need to revise the guideline on the clinical development of fixed dose combinations of medicinal products regarding dossier content requirements - Draft

07.03.2013
The current guideline CHMP/EWP/240/95 Rev. 1 contains a section describing the legal basis applicable to fixed dose combination (FDC) product marketing authorisation application (MAA). ...

EMA: Concept paper on the need for revision of note for guidance on clinical investigation of medicinal products for the treatment of cardiac failure - Draft

07.03.2013
Chronic Heart Failure (CHF) encompasses heterogeneous groups of patients with a wide spectrum of symptoms and different causes. The CHMP Guideline on the clinical investigations of medicinal ...

EMA: Guideline on the use of porcine trypsin used in the manufacture of human biological medicinal products - Draft

07.03.2013
This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin. ...

GMP: European Medicines Agency recommends approval of first vaccine for meningitis B

07.03.2013
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero, a new vaccine intended for the ...

GMP: ICH publishes New Draft Guideline on Genotoxic Impurities

07.03.2013
The ICH has published a draft guideline for comment on the determination and the control of DNA reactive (mutagenic) impurities in medicinal products. The guideline is entitled: \"M7: Assessment ...

Polish Ministry of Health: Project regarding amendment of law - Pharmaceutical law and other regulations

28.02.2013
This document of Polish Ministry of Health concerns amendment of regulation - Pharmaceutical law and other regulations ...

EMA: International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline M7 on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogen

28.02.2013
The purpose of this guideline is to provide a practical framework that can be applied for the identification, categorisation, qualification and control of mutagenic impurities to limit potential ...

FDA: Guidance for Industry: Labeling for Human Prescription Drug and Biological Products – Implementing the PLR Content and Format Requirements

28.02.2013
This guidance is intended to assist applicants in complying with the content and format requirements of labeling for human prescription drug and biological products under 21 CFR 201.56(d) and ...

FDA: Draft - Guidance for Industry M3(R2) Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals Questions and Answers(R2)

28.02.2013
Although the ICH M3(R2) guidance is still in its early phases of the implementation, the complexity of the guidance, its broader scope, and numerous changes in recommendations from the M3(R1) ...

GMP: Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline

28.02.2013
The new guideline is addressed to distribution organisations and  distributors involved in the procuring, import, exporting, holding or supplying active substances. Re-packaging, re-labelling or ...

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