GMP: FDA strives for more Transparency regarding GMP Compliance and Enforcement Data

The U.S Food and Drug Administration (FDA) released 8 new draft proposals in a report titled \"Food and Drug Administration Transparency Initiative: Draft Proposals for Public Comment to Increase ...

GMP: New Document about Duplicate Marketing Authorisation Applications

According to Article 82 of the EU Regulation No 726/2004 \"only one authorisation may be granted to an applicant for a specific medicinal product\". In exceptional cases though, the same applicant ...

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

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

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

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

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

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

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

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

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 ...

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