Aktualności
EMA: Guideline on the use of phthalates as excipients in human medicinal products
27.11.2014
This guideline covers the phthalates most commonly used as excipients in medicinal products authorised in the EU. The recommendations provided in this document apply to new and existing marketed
...
GMP: New Q&A concerning Visual Inspection
27.11.2014
The topic 100 percent visual control of parenterals constantly raises new questions, especially as concerns the use of automatic inspection machines or if statistical issues emerge concerning AQL
...
EMA: Concept paper for a guideline on data requirements regarding veterinary medicinal products for the prevention of transmission of canine and feline vector-borne diseases
20.11.2014
Vectors are living organisms - such as diptera (mosquitoes, sand flies, muscid flies), ticks, fleas and lice - that transmit a disease from an infected animal to a human or another animal.
...
EMA: Concept paper for the revision of the guidelines on data requirements for veterinary medicinal products for minor use minor species
20.11.2014
The European Medicines Agency, together with the European medicines regulatory network, aims to facilitate the access of products indicated for minor use minor species (MUMS) / limited market to
...
FDA: Rare Pediatric Disease Priority Review Vouchers, Draft Guidance for Industry
20.11.2014
This guidance provides information on the implementation of section 908 of the Food and Drug Administration Safety and Innovation Act (FDASIA), which added section 529 to the Federal Food, Drug,
...
EMA: Draft qualification opinion on in vitro hollow-fibre-system model of tuberculosis (HFS-TB)
20.11.2014
Approximately 10 years ago, the HFS-TB was developed by Gumbo et al. and first presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Since that time, the model
...
EMA: Questions and answers: Positions on specific questions addressed to the Pharmacokinetics Working Party,
20.11.2014
In the context of assessment procedures, the Pharmacokinetics Working Party (PKWP), or its predecessor the Therapeutic Subgroup on Pharmacokinetics of the Efficacy Working Party (EWP-PK subgroup),
...
GMP: ECA and PQG publish next chapter of the interpretation of the EU GDP Guide
13.11.2014
The ECA Foundation Working Group on GDP and the Pharmaceutical Quality Group (PQG) have published an additional chapter of the interpretation of the EU Good Distribution Practice (GDP Guide). ...
EMA: List of centrally authorised products requiring a notification of a change for update of annexes
13.11.2014
Parallel distributors are only required to inform the EMA of changes to the labelling or leaflet related to any update of the annexes of marketing authorisation once a year in their annual update
...
EMA: Procedural advice on CHMP/CAT/PRAC Rapporteur/Co-Rapporteur appointment principles, objective criteria and methodology in accordance with Article 62 (1) of Regulation (EC) No 726/2004
13.11.2014
This paper sets the principles, objective criteria and the methodology on the rapporteur/co-rapporteur appointment procedure. These principles and objective criteria shall apply to several
...
