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EMA: Guideline on process validation for finished products - information and data to be provided in regulatory submissions

05.03.2014
This guideline replaces the previous note for guidance on process validation (CPMP/QWP/848/96, EMEA/CVMP/598/99). The guideline is brought into line with ICH Q8, Q9 and Q10 documents and the ...

EMA: Draft concept paper on revision of the points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CHMP/EWP/2655/99) and conversion to a CHMP guideline

05.03.2014
This concept paper proposes a revision of the CHMP’s points to consider on pharmacokinetics and pharmacodynamics in the development of antibacterial medicinal products (CPMP/EWP/2655/99) and its ...

EMA: Draft guideline on the evaluation of the pharmacokinetics of medicinal products in patients with decreased renal function

05.03.2014
Pharmacokinetic studies can be used to estimate drug exposure in subpopulations of patients with characteristics that might affect the pharmacokinetics of the drug, and alternative dosing regimens ...

EMA: Draft guideline on core SmPC for human fibrinogen products

05.03.2014
This guideline describes the information to be included in the Summary of Product Characteristics (SmPC) for Human Fibrinogen, which is indicated for the treatment and prophylaxis of bleeding in ...

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

05.03.2014
This guideline describes the information to be considered by the manufacturer of human biological medicinal products using porcine trypsin. Although specific guidance and specification has been ...

GMP: PIC/S revises Annex 14 for Medicinal Products derived from Human Blood or Plasma

27.02.2014
The document provides specific guidance on GMP practices related to the collection, processing, storage and transport. ...

GMP: PIC/S GMP Guideline - Revised Annex 2 for biological Substances and Products adopted

27.02.2014
The PIC/S published the current revision of their GMP Guide (PE 009-11). The revised Guide will become effective on 1 March 2014. ...

MHRA: Marketing authorisations: Types of application

27.02.2014
There are several alternative procedures to choose from depending on which countries the product is going to marketed in and the type of medicine. ...

GMP: FDA publishes new Guidance on Validation of Analytical Methods

27.02.2014
This Guideline replaces the Guidance for Industry \"Analytical Procedures and Methods Validation\" from 2000 and - when finalised - should also replace the \"Guidelines for Submitting Samples and ...

EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances

20.02.2014
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance. There are currently two approved guidelines on the subject; ...