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GMP: EMA Guideline on the use of bovine serum in the manufacture of human biological medicinal products

29.08.2013
On 1 December 2013, the adopted Guideline on the use of bovine serum in the manufacture of human biological medicinal products will come into effect. It replaces the Note for Guidance on the use ...

FDA: ANDAs: Stability Testing of Drug Substances and Products, Questions and Answers - Draft Guidance

29.08.2013
This draft guidance provides answers to questions from the public comments we received on the draft guidance for industry on ANDAs: Stability Testing of Drug Substances and Products (stability ...

FDA: Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring

29.08.2013
At the beginning of August, the FDA released a guideline on monitoring of clinical trials. This document is the final version of a draft dated August 2011 in which a few comments have been ...

EMA: This paper highlight s issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration

22.08.2013
This paper highlights issues that require consideration during the development and lifecycle of coated nanomedicine products designed for parenteral administration. ...

GMP: Frequently asked GMP Question: How to reduce testing and comply with GMP?

22.08.2013
Testing active pharmaceutical ingredients, excipients and packaging materials is one of the main tasks of the quality control units in the pharmaceutical industry. It must be ensured that the ...

GMP: Interesting APIC/CEFIC Guideline for the Qualification of Contract Laboratories

22.08.2013
The guideline is supposed to define uniform requirements for the \"life cycle management\" of contract laboratories. In addition the APIC had already prepared a guideline for the management of ...

GMP: What\'s new from the FDA regarding Medical Devices?

22.08.2013
In hardly any other area the FDA ‘s Center for Devices and Radiological Health publishes so many guidelines as in the area of medical devices. This is a consequence of the wide range of medical ...

GMP: New EMA Guideline on Starting Materials from Biological Medicinal Products

22.08.2013
The Guideline describes the requirements for the quality documentation of module 3 of the marketing authorisation dossier. Here, the complete manufacturing process including all sources as well as ...

EMA: Draft guideline on clinical investigation of medicinal products for the treatment of amyotrophic lateral sclerosis

08.08.2013
This document replaces and updates the previous points to consider on amyotrophic lateral sclerosis and focuses on the design of studies for disease-modifying as well as symptomatic treatments in ...

EMA: Concept paper on the development of product-specific guidance on demonstration of bioequivalence

08.08.2013
This document describes for specific products the regulatory view on specific aspects related to the demonstration of bioequivalence based on previous assessments of generic medicines. ...