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EMA: Guidance on centrally authorised products requiring a notification of a change for update of annexes

20.10.2011
EMA communicated to all Parallel Distributors that it is not required to inform the EMA on changes to the labelling or leaflet related to any update of the annexes, except for those when the EMA ...

EMA: Concept paper for a guideline on the quality of porcine trypsin used in the manufacture of human biological medicinal products

13.10.2011
Porcine trypsin is a common reagent used during the manufacture of biological medicinal products for the detachment of cells from the culture vessel for their passage. At manufacture of some ...

FDA: Warnings and Precautions, Contraindications, and Boxed Warning Section of Labeling for Human Prescription Drug and Biological

13.10.2011
This guidance is intended to assist applicants and reviewers in drafting the “Warnings and Precautions, Contraindications, and Boxed Warning” sections of labeling for human prescription drug ...

FDA: Incorporation of Physical- Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting

13.10.2011
This document is intended to provide guidance to pharmaceutical manufacturers who want to use physical-chemical identifiers (PCIDs) in solid oral dosage forms (SODFs). A PCID is a substance or ...

GMP: Technical Report - Assistance for Biotechnology Cleaning Validation

13.10.2011
Since the Nineties, cleaning validation has been a topic in the area of GMP. Most guidelines cover the topic of cleaning validation only in a general way. The PDA\'s Technical Report No. 49 ...

URPL: EudraVigilance System - Communication

11.10.2011
On 1 July 2011 the European medicines Agency (EMA) has published the format, in which by 2 July 2012 pharmaceutical companies shall submit information on all of the medicines for human use ...

TOPRA: European Commision v Republic of Poland

11.10.2011
Failure of a Member State to fulfil obligations - Directive 2001/83/EC -Article 6 -Marketing authorisation - Article 5 - Exclusion from provisions of directive for medicinal products ordered for ...

EMA: Concept paper on the revision of the guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues

04.10.2011
The Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/BMWP/42832/2005) lays down the ...

EMA: Guideline on core SmPC and Package Leaflet for Radiopharmaceuticals

04.10.2011
This guideline describes the information to be included in the Summary of Products Characteristics (SmPC) and Package Leaflet for Radiopharmaceuticals. ...

EMA: Guideline on quality of herbal medicinal products/traditional herbal medicinal products

04.10.2011
This guideline intends to cover the general quality aspects of herbal medicinal products (for human and veterinary use), including traditional herbal medicinal products for human use. The special ...

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