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EMA: New guide on biosimilar medicines for healthcare professionals

11.05.2017
The European Medicines Agency (EMA) and the European Commission have published an information guide for healthcare professionals on biosimilar medicines. Biosimilars are biological medicines that ...

GMP: EMA - requirements for quality documentation concerning biological investigational medicinal products

08.09.2016
Already in 2012, the European Commission published a guideline on the quality documentation for IMP in clinical trials. Now on 23 June, the EMA issued a draft \"Guideline on the requirements for ...

GMP: FDA´s new policy regarding grouping of supplements for CMC changes

09.06.2016
On April 19, 2016 the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) released a new document outlining how supplements can be grouped together and submitted ...

RAPS: FDA Amends Regulations on General Biologic Standards for First Time Since 1977

11.05.2016
The revisions to US Food and Drug Administration’s (FDA) regulations, announced Tuesday, are designed to remove unnecessary or outdated biologics requirements and allow industry to employ new ...

RAPS: EMA Finalizes Process Validation Guidance

11.05.2016
The European Medicines Agency (EMA) has finalized guidance intended to help sponsors meet the data requirements for process validation for biotechnology-derived active substances. The guidance, ...

FDA: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of Hepatitis B Virus from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

11.01.2016
We, FDA, are providing you, establishments that make donor eligibility determinations for donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), with recommendations ...

FDA: Revised Recommendations for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products

11.01.2016
This guidance document provides you, blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with ...

EMA: Draft concept paper on the revision of the reflection paper on non-clinical and clinical development of similar biological medicinal products containing recombinant interferon alpha or pegylated recombinant interferon alpha

11.01.2016
The current reflection paper on similar medicinal products containing recombinant interferon alpha provides recommendations for the non-clinical and clinical development of recombinant interferon ...

EMA: Guideline on good pharmacovigilance practices (GVP): Product- or Population-Specific Considerations II: biological medicinal products

29.12.2015
Product- or Population-Specific Considerations II: biological medicinal products. ...

FDA: Dissolution Testing and Specification Criteria for Immediate-Release Solid Oral Dosage Forms Containing Biopharmaceutics Classification System Class 1 and 3 Drugs

13.08.2015
This guidance is developed to provide manufacturers with recommendations for submission of new drug applications (NDAs), investigational new drug applications (INDs), and/or abbreviated new drug ...