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FDA: Draft - Guidance for Industry Allowable Excess Volume and Labeled Vial Fill Size in Injectable Drug and Biological Products

20.03.2014
This draft guidance provides the pharmaceutical industry with the Center for Drug Evaluation and Research’s (CDER’s) and the Center for Biologics Evaluation and Research’s (CBER’s) current ...

FDA: Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports

13.03.2014
A new guidance finalized by the US Food and Drug Administration (FDA) is meant to clarify which events and changes sponsors of new and generic drug products need to report in their annual reports ...

EMA: Draft guideline on the evaluation of medicinal products for the treatment of chronic constipation

13.03.2014
This guideline intends to address the EU regulatory position in the main topics of clinical development of new medicinal products in the treatment of chronic constipation, opioid-induced ...

EMA: Interim guidance on enhanced safety surveillance for seasonal influenza vaccines in the EU

13.03.2014
Seasonal influenza vaccines present several specific challenges for pharmacovigilance. These include mass immunisation in large population cohorts in a relatively short and fixed time period each ...

GMP: GDP - Q&As for Wholesale Distribution of Medicines

13.03.2014
The Danish Health and Medicines Authority (DHMA) has recently updated its \"wholesale distribution of medicines within the EU/EEA questions and answers\" document. It gives some valuable ...

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 ...